Healthcare Compliance News

Trump Administration Appoints Deputy HHS Secretary & National Coordinator for Health IT

There have been a further two appointments to leadership positions at the U.S. Department of Health and Human Services (HHS). Robert F. Kennedy, Jr., has sworn in Jim O’Neill as Deputy HHS Secretary, and Thomas Keane, MD, MBA, has been named as the new Assistant Secretary for Technology Policy/National Coordinator for Health Information Technology. Last week, the HHS appointed Paula M Stannard as the new Director of the HHS’ Office for Civil Rights (OCR).

Deputy HHS Secretary, Jim O'Neill

Jim O’Neill, Deputy Secretary, Department of Health and Human Services.

Jim O’Neill is a HHS veteran, having served in the department for almost six years between 2002 and 2008, first as Director of the Speech and Editorial Division, then Associate Deputy Secretary and Senior Advisor to the Deputy Secretary, and as Principal Associate Deputy Secretary between 2007 and 2008. In the latter role, O’Neill led reforms at the U.S. Food and Drug Administration (FDA) to overhaul food safety regulations and implemented the FDA Amendments Act to improve the safety of drugs and medical devices.

After leaving the HHS, O’Neill oversaw the development of tools and techniques for enhancing background checks as a member of the Suitability and Security Clearance Performance Accountability Council, served as Managing Director at the global macro hedge fund Clarium Captial Management, Acting CEO of the Thiel Foundation supporting nonprofits promoting technology and freedom, and co-founded the Thiel Fellowship, which has helped many young entrepreneurs found science and tech firms.

O’Neill has also served on the Board of Directors at Advantage Therapeutics Inc., as Board Observer at Oisin Biotechnologies, and was on the Board of Directors at the SENS Research Foundation, where as CEO he led efforts to research and develop regenerative medicine solutions for age-related diseases such as Alzheimer’s, heart disease, and cancer.

“Jim O’Neill’s extensive experience in Silicon Valley and government makes him ideally suited to transition HHS into a technological innovation powerhouse. He will help us harness cutting-edge AI, telemedicine, and other breakthrough technologies to deliver the highest quality medical care for Americans,” said Secretary Kennedy. “As my deputy, he will lead innovation and help us reimagine how we serve the public. Together, we will promote outcome-centric medical care, champion radical transparency, uphold gold-standard science, and empower Americans to take charge of their own health.”

“I am deeply honored to return to HHS,” said Deputy Secretary O’Neill. “All Americans deserve to be healthy, happy, and prosperous, and President Trump and Secretary Kennedy have the right vision and leadership to get us there.”

Assistant Secretary for Technology Policy/National Coordinator for Health Information Technology, Thomas Keane, MD.

Thomas Keane, MD. Assistant Secretary for Technology Policy/National Coordinator for Health Information Technology.

Thomas Keane, MD, MBA, has also rejoined the HHS, becoming the second Assistant Secretary for Technology Policy and the ninth National Coordinator for Health Information Technology (ASTP/ONC). Dr. Keane, a physician, engineer, and interventionalist radiologist, previously served at the HHS as Senior Advisor to the Deputy Secretary of Health and Human Services.

Keane was an administrator of the COVID-19 Provider Relief Fund and led the development of the AHRQ National Nursing Home COVID Action Network, which helped improve infection control and safety practices in nursing facilities. Dr. Keane has also served as CEO of Radiology Associates of Southeastern Ohio, an interventional radiology fellow at Johns Hopkins Hospital, and a radiology resident at New York Presbyterian Hospital. In the new role, DR. Keane will play a key role in shaping the future of Health IT and the HHS technology strategy.

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Michigan House Passes Bill Requiring Medical Records to be Stored Domestically

The Michigan House of Representatives has passed a bill (HB 4242) that seeks to protect the sensitive health data of state residents from foreign entities of concern by requiring electronic medical records to be stored in the United States or Canada.

If signed into law, Michigan residents will have peace of mind that their sensitive healthcare data will be protected from all foreign entities of concern on the federal watch list, namely The People’s Republic of China, the Russian Federation, the Islamic Republic of Iran, the Democratic People’s Republic of Korea, the Republic of Cuba, the Venezuelan regime of Nicolas Maduro, and the Syrian Arab Republic.

The bill was introduced by Rep. Jamie Thompson (R) and requires licensees that use off-site physical or virtual environments for electronic medical records to ensure that the physical or virtual environment is physically maintained in a U.S. state or Canadian province, including if the medical records are maintained by a third-party medical records company.  If passed, healthcare regulatory compliance fines of up to $10,000 can be imposed if the failure was due to gross negligence or willful and wanton misconduct.

“Ensuring our health care record technology is physically maintained in the US or Canada, as my bill does, is a needed step Michigan should take to protect the personal and private health information of people we all represent,” explained Thompson. “Our adversaries abroad frequently try to compromise our national security and access information within our country. We should be updating our laws to reflect this reality and installing commonsense safeguards to protect residents.”

Under federal HIPAA law, healthcare providers are required to implement safeguards to ensure the confidentiality, integrity, and availability of electronic protected health information; however, HIPAA does not require medical records to be maintained in the United States or Canada.

In 2023 and 2024, more than 700 large healthcare data breaches were reported to the HHS’ Office for Civil Rights, with large data breaches reported at a rate of more than two per day. “If these breaches come from a foreign adversary of the United States, the fallout could be profound,” Rep. Thompson said. “In addition, the lack of trust resulting from a privacy breach can cause patients to potentially withhold serious information that may help get them needed care. As a licensed practical nurse, I find this element very concerning as well.”

Several other bills have been introduced with requirements to protect data from foreign influence (House Bills 4233-35 and 4238-42). They include provisions that prevent foreign entities of concern from collecting sensitive information by blocking prohibited apps on government devices; prevent public bodies from entering into constraining agreements with foreign entities of concern; ensure public economic incentives are not awarded to foreign entities of concern; and prevent entities of concern from purchasing land and surveilling military bases and other critical infrastructure. The bills will now be considered by the Senate.

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Albany ENT & Allergy Services Pays $500K Penalty and Commits to $2.25M Cybersecurity Investment

The New York multi-site medical practice, Albany ENT & Allergy Services, has agreed to pay a $500,000 financial penalty to the state of New York and will invest $2.25 million to strengthen its information security practices after suffering two ransomware attacks that saw threat actors gain access to the medical records of more than 213,000 New York patients. Under the agreement, a further $500,000 in penalties must be paid if Albany ENT & Allergy Services fails to invest the required $2.25 million in upgrades and maintenance of its information security program over the next 5 years.

An investigation was launched by the Office of the New York Attorney General (OAG) following an intrusion of Albany ENT & Allergy Services’ network by two different threat actors between March 23, 2023, and April 4, 2023. The first intrusion involved ransomware and was discovered on March 27, 2023, when files were encrypted. Systems and data were restored by the healthcare provider’s IT vendor; however, the source of the intrusion was not identified before the restoration of external network access.

A different threat actor conducted a second ransomware attack 10 days later on April 2, 2023. A digital forensics firm was engaged to conduct a thorough investigation and remediate any vulnerabilities before the restoration process began. The compromised systems contained the records of 213. 935 patients, including names, addresses, birth dates, driver’s license numbers, Social Security numbers, diagnoses, test results, and treatment information.  Both threat actors provided evidence of data exfiltration when attempting to extort Albany ENT & Allergy Services; however, ransoms were not paid. The file review was completed in May 2023 and the affected individuals were notified and offered complimentary credit monitoring services.

The failure to identify the initial access vector was due to insufficient server logs. While server logs were created, they were not retained for a reasonable period, and there were no security programs in place to monitor and analyze server traffic. The company that conducted the forensic investigation after the second attack concluded that the initial access vector was likely the exploitation of an unpatched vulnerability in a Cisco VPN firewall.

The OAG investigation revealed the breach involved the protected health information of around 80,000 individuals more than the 120,000 individuals stated in the initial breach report. The additional affected individuals had their driver’s license numbers posted online by the threat actors when the ransom was not paid. OAG also determined that the threat actors gained access to six devices that hosted unencrypted personal information and some of those devices continued to store unencrypted personal information for months after the ransomware attacks. While an encryption policy had been implemented for laptop computers, it did not apply to personal information stored on other systems. Multi-factor authentication (MFA) had been implemented, but not consistently, with some remote access systems not protected by MFA.

Albany ENT & Allergy Services did not have an in-house information technology team and outsourced those functions to two third-party vendors. Outsourcing IT functions is acceptable under state law; however, a single Albany ENT & Allergy Services employee was responsible for liaising with those vendors and ensuring appropriate policies and procedures were followed and recommended practices were implemented. That employee did not have any IT or InfoSec experience or training. The lack of effective oversight meant critical security updates were not implemented in a timely manner, logs of activity in information systems were not retained for sufficiently long, MFA was not consistently implemented, and a reasonable information security program was not maintained. The security failures were determined to violate New York Business and Executive Law.

Under the agreement, Albany ENT & Allergy Services is required to implement a range of security measures including establishing a comprehensive information security program and ensuring effective oversight of its information security vendors. “Health care facilities need to take protecting patients’ private information seriously, and that means investing to protect data and responding quickly if breaches occur. Today’s agreement with AENT will strengthen its cybersecurity and protect the private information of New Yorkers who rely on this Capital Region medical provider,” said Attorney General Letitia James. “I urge all health care facilities and general companies to follow guidance from my office on how to have more secure systems to protect New Yorkers’ data.”

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Industry Groups Give Feedback on CISA’s Proposed Cybersecurity Reporting Requirements

In April, as required by the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA), the Cybersecurity and Infrastructure Security Agency (CISA) issued a Notice of Proposed Rulemaking (NPRM) introducing new requirements for critical infrastructure entities to report certain cybersecurity incidents. CISA sought comment from the public, and several healthcare stakeholders have provided feedback on the proposed rule.

Background

The proposed rule requires critical infrastructure entities to report cybersecurity incidents to CISA within 72 hours of detecting a cybersecurity incident and within 24 hours of making a ransomware payment. The types of covered incidents include:

  • Unauthorized system access
  • Denial of Service (DOS) attacks with a duration of more than 12 hours
  • Malicious code on systems, including variants if known
  • Targeted and repeated scans against services on systems
  • Repeated attempts to gain unauthorized access to systems
  • Email or mobile messages associated with phishing attempts or successes
  • Ransomware attacks against critical infrastructure, including the variant and ransom details if known

The types of information that must be submitted to CISA include:

  • Incident date and time
  • Incident location
  • Type of observed activity
  • Detailed narrative of the event
  • Number of people or systems affected
  • Company/Organization name
  • Point of Contact details
  • Severity of event
  • Critical infrastructure sector
  • Anyone else who has been informed

CISA will share the information with federal and non-federal partners to improve detection and the minimization of the harmful impacts on critical infrastructure entities, accelerate mitigation of exploited vulnerabilities, and allow software developers and vendors to develop more secure products. The information will also be shared with law enforcement to help with the investigation, identification, capture, and prosecution of the perpetrators of cybercrime.

Healthcare Industry Groups Give Feedback to CISA

The Workgroup for Electronic Data Interchange (WEDI) and the Medical Group Management Association (MGMA) have called for CISA to align the reporting time frame with the HHS’ Office for Civil Rights, as having to submit reports to multiple agencies will place a considerable administrative burden on healthcare organizations. MGMA believes the new reporting requirements will be overly burdensome for medical groups, and the duplicative reporting requirements may affect the ability of those groups to operate effectively, especially when dealing with a cyberattack.

MGMA explained that under HIPAA, covered entities must report cybersecurity incidents to the HHS’ Office for Civil Rights within 60 days for HIPAA compliance. Rather than layering different reporting requirements on each other, MGMA suggests that CISA should work closely with the HHS to seamlessly incorporate data that must reported under HIPAA. This will promote collaboration and prevent covered entities from reporting the same incident multiple times in different formats. MGMA said the sized-based criteria for reporting means small medical groups will not have the burden of reporting incidents but using the SBA definition means that many small physician offices will be impacted, even practices with annual revenues as low as $9 million.

The short timeframe for reporting incidents was criticized by WEDI, which said it could take longer than 72 hours to gather all the necessary information for the initial report. WEDI has called for CISA to be flexible with the reporting timeframe, such as allowing the initial report to be submitted with as much information as it has been possible to gather within 72 hours and allowing additional information to be submitted after that deadline as it becomes available. WEDI also proposes a carve-out for certain ransomware attacks. WEDI has requested that CISA not consider an attack to be a data breach if no protected health information has been accessed, provided the entity has made a good faith effort to deploy a recognized security program and has implemented security policies and procedures.

CHIME/AEHIS Members Express Concern

The College of Healthcare Information Management Executives (CHIME) and the Association for Executives in Healthcare Information Security (AEHIS) have urged CISA to consider that the core mission of healthcare is patient safety and not to implement regulatory requirements that could jeopardize that mission.

One concern from their members is the reporting requirements under HIPAA, which require security breaches to be reported to OCR within 60 days of the discovery of a data breach. They are concerned that the clock would start ticking for reporting under HIPAA on the date of submission of the incident report to CISA, and that could create considerable additional burdens for HIPAA-regulated entities. CHIME and AEHIS have asked CISA to clarify the reporting requirements for managed service providers and other third-party service providers that provide products or services to HIPAA-covered entities, requesting that the service provider be considered the covered entity for reporting under CIRCIA.

After the initial incident report, critical infrastructure entities are required to submit supplemental reports following a significant cybersecurity incident, with those supplemental reports submitted without delay or as soon as possible. There is concern that with the threat of enforcement, HIPAA-covered entities may feel compelled to prioritize reporting of incidents over patient safety. CHIME/AEHIS have requested that the supplemental reports be submitted every 72 hours at a minimum or every 5 days, and for those reports to only be required if substantial new or different information becomes available.

CHIME/AEHIS point out that the definition of larger hospitals – those with 100 or more beds – is inadequate and that a more nuanced approach is required with other factors considered other than bed count, and not require reporting of incidents by critical access hospitals (CAHs), which are already under considerable financial strain. Making CAHs report incidents could increase the financial strain on the hospitals, leading to more closures and reduced access to healthcare for patients.

CHIME/AEHIS have received feedback from their members about the level of detail required by CISA about the security architecture of breached entities. “If CISA requires hospitals and healthcare systems to define their entire security architecture, that is a tremendous amount of information to include in a report,” explained the industry groups. “Our members do not believe that CISA needs to know an entire description of an organization’s security program – as it is not helpful to fulfill the purpose of CIRCIA, is potentially considered intellectual property (IP), and/or sensitive for the organization.”

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ONC Releases Common Agreement Version 2.0

On April 22, 2024, the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) released Version 2.0 of the Trusted Exchange Framework and Common Agreement (TEFCA).

TEFCA establishes the technical infrastructure model and governing approach for different health information networks and their users and allows them to share clinical information with each other. The ONC requires health information networks that participate in TEFCA to begin implementing the new version and support the Health Level Seven Fast Healthcare Interoperability Resources standard. ONC has also published Participant and Subparticipant Terms of Participation, which details the requirements for Participants and Subparticipants, compliance with which is required for participation in TEFCA. Version 2.0 of the Common Agreement will make it easier for participating health information networks to share data with each other and will also make it easier for patients to access their health data through digital health apps.

“We have long intended for TEFCA to have the capacity to enable FHIR API exchange. This is in direct response to the health IT industry’s move toward standardized APIs with modern privacy and security safeguards, and allows TEFCA to keep pace with the advanced, secure data services approaches used by the tech industry,” said Micky Tripathi, Ph.D., national coordinator for health information technology. “I want to commend the effort put forth by the TEFCA and FHIR communities to help get us there with the release of CA v2.0.”

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NY Attorney General Finds Northwell Health Deceptively Advertised COVID-19 Testing Sites

New York Attorney General, Letitia James, has announced a settlement with New York’s largest health network, Northwell Health, to resolve allegations it deceptively advertised its emergency departments as COVID-19 testing sites during the COVID-19 public health emergency. Northwell Health claimed in advertisements that three emergency departments in New York City and Long Island were COVID-19 testing sites; however, when patients visited to be tested they were billed for emergency room visits.

The Office of the Attorney General (OAG) investigated Northwell Health after complaints were received from patients who claimed they had been overcharged for testing. OAG investigated and found that Lenox Hill Hospital, Lenox Health Greenwich, and Huntington Hospital had signs advertising their emergency departments as COVID-19 testing sites between March 2020 and March 2021. Hundreds of patients visited the emergency departments solely to be tested for COVID-19 but were billed standard emergency department charges. In the case of Huntington Hospital, even patients who used the drive-in testing facility were charged for emergency room visits. OAG determined that Northwell Health collected $81,761.46 in out-of-pocket payments from 559 New Yorkers for COVID-19 tests and related services, and patients visiting the emergency department for other reasons were also charged for COVID-19 tests.

OAG found that the actions of Northwell Health violated New York Executive Law § 63(12) and General Business Law §§ 349 and 350. Under the terms of the settlement, Northwell Health has issued more than $400,000 in refunds to 2,048 patients and will pay a civil monetary penalty of $650,000 to the state. “During a time of great stress at the height of the pandemic, Northwell Health caused more worry and frustration for New Yorkers who were sent emergency room bills for simply taking a COVID-19 test,” said Attorney General James. “Today we are putting money back in New Yorkers’ pockets after Northwell Health misled them. New York patients should not get surprise fees, and I encourage anyone who thinks they’ve been taken advantage of through deceptive advertising to file a complaint with my office.”

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One Third of Healthcare Websites Still Use Meta Pixel Tracking Code

A recent analysis of healthcare websites by Lokker found widespread use of Meta Pixel tracking code. 33% of the analyzed healthcare websites still use Meta pixel tracking code, despite the risk of lawsuits, data breaches, and fines for non-compliance with the HIPAA Rules.

Website Tracking Technologies in Healthcare

A study conducted in 2021 that looked at the websites of 3,747 U.S. hospitals found 98.6% of the hospitals used at least one type of tracking code on their websites that transferred data to third parties, and an analysis in 2022 of the websites of the top 100 hospitals in the United States by The Markup/STAT revealed one-third of those hospitals used tracking technologies on their websites that transferred visitor data, including protected health information (PHI), to third parties.

In December 2022, the HHS’ Office for Civil Rights issued guidance to HIPAA-regulated entities on the use of website tracking technologies. The guidance made it clear that these technologies violate HIPAA unless there is a business associate agreement (BAA) in place with the provider of the code or authorizations are obtained from patients. OCR and the Federal Trade Commission wrote to almost 130 healthcare organizations in July 2023 warning them about the compliance risks of using tracking technologies, after these tools were discovered on their websites. In March 2024, OCR updated its guidance – believed to be in response to a legal challenge by the American Hospital Association –  however, OCR’s view that a BAA or authorizations are required has not changed.

Several hospitals and health systems have reported the use of these tracking technologies to OCR as data breaches, and many lawsuits have been filed against hospitals over the use of these tools, some of which have resulted in large settlements. For example, Novant Health agreed to pay $6.6 million to settle a lawsuit filed by patients who had their PHI transferred to third parties due to the use of these tracking tools. The FTC is also actively enforcing the FTC Act with respect to trackers, with BetterHelp having to pay $7.8 million to consumers as refunds for disclosing sensitive health data without consent. States have also taken action over the use of Meta pixel and other website trackers, with New York Presbyterian Hospital settling a Pixel-related HIPAA violation case with the New York Attorney General for $300,000.

Lokker’s 2024 Study of Website Tracking Technologies

Lokker, a provider of online data privacy and compliance solutions, conducted a study of 3,419 websites across four industries (healthcare, technology, financial services, and retail), that explored three critical areas of risk.

  • Unauthorized consumer data collection through third-party trackers, tags, and pixels.
  • How privacy tools are often failing to meet the requirements of emerging laws.
  • The escalating complexities of protecting consumers’ data privacy.

The study looked at the threat of data brokers sharing consumer data with foreign adversaries. Across all industries, 12% of websites had the TikTok pixel, including 4% of healthcare companies. While the privacy risks associated with this pixel are lower than other tracking technologies, the information collected by TikTok pixel may be transferred to China. 2% of websites, including 0.55% of healthcare websites, were found to use pixels and other web trackers that originated in China, Russia, or Iran. Data transfers to foreign nations are a major concern for the U.S. government. In February this year, President Biden signed an Executive Order to prevent the sharing of Americans’ data with foreign countries.

Alarmingly, given the considerable media coverage, HIPAA guidance, regulatory fines, and lawsuits associated with website tracking technologies, 33% of healthcare organizations were still using Meta pixel on their websites. Lokker found an average of 16 trackers and a maximum of 93 trackers on healthcare websites. The most common trackers used by healthcare organizations were from Google (googletagmanager.com, doubleclick.net, google-analytics.com, google.com, googleapis.com, youtube.com), Meta (facebook.com, facebook.net), ICDN (icdn.com), and Microsoft (linkedin.com). There appears to be confusion about obtaining consent from website visitors about the collection of their data through tracking technologies such as pixels and cookies. According to OCR guidance, the use of a banner on a website advising visitors about the use of tracking technologies does not constitute a valid HIPAA authorization. These consent banners were identified on the websites of 59% of healthcare organizations.

These consent banners often do not function as intended, as 98.5% of websites load cookies on page load, with Lokker reporting that, on average, 33 cookies are loaded before consent banners appear, and these banners often misclassify or overlook cookies and trackers. Lokker also found that technologies such as browser fingerprinting are often excluded from consent tools, and the rapidly evolving web means tracker changes may go unnoticed by consent tools, resulting in users unwittingly consenting to undesired data collection.

In addition to compliance risks related to HIPAA, there is also a risk of Video Privacy Protection Act (VPPA) violations. 3% of healthcare companies had Meta pixel or other social media trackers on pages containing video players, putting them at risk of VPPA lawsuits. In 2023, more than 80 lawsuits were filed alleging VPPA violations due Meta pixel being used to gather and disseminate video viewing data from websites without user consent, some of which have led to multi-million-dollar settlements.

“LOKKER’s research sheds light on critical issues that businesses often underestimate. Unauthorized data collection through third-party trackers and related technologies is far more pervasive than most people realize. We all build websites with third-party tools, and they use other third-party tools, and so on. Many of these are essential and necessary. However, this web of interconnected technologies produces dozens to hundreds of URLs collecting data on a single webpage and is the engine that powers the data broker market,” said Ian Cohen, founder and CEO of LOKKER. “Moreover, data collection on websites and ad tech happens in real time; existing privacy tools are not real-time, and therefore not getting the job done. As a result, we’re seeing a dramatic increase in privacy violations, lawsuits, and fines.” The findings are published in Lokker’s Online Data Privacy Report March 2024.

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ONC Reports on Progress on Advancing Nationwide, Trusted Health Information Networks

The HHS Office of the National Coordinator for Health Information Technology (ONC) has provided an update to Congress on the progress that has been made on the access, exchange, and use of electronic health information through trusted health information networks (HINs) and health information exchanges (HIEs).

HealthIT is integral to healthcare delivery, and it has become even more so since the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. Across the United States, hundreds of physician offices, hospitals, and health systems now use ONC-certified healthIT to access, process, store, and exchange electronic health information (EHI) and ONC reports significant progress in the past year toward nationwide interoperability, and connecting nationwide, trusted HINs.

According to the ONC report, 85% of hospitals have electronically queried or found patient health information through various methods; 64% of hospitals reported using nationwide networks that enable data exchange across different healthIT systems in 2021, around half of physicians searched for or queried patient health information via their EHR when seeing a new patient in 2021, and HINs are one of the most common methods used by hospitals to electronically send and receive summary of care cards.

There are, however, barriers to progress. As explained to Congress in a February 2023 report, those barriers have resulted in uneven progress across healthcare and have affected the ability to realize the full potential of certified health IT. In 2021, 72% of hospitals reported challenges exchanging data across different EHR vendor platforms, 54% faced challenges developing customized interfaces, 57% faced challenges matching and identifying the correct patient between systems, and in 2022, around three-quarters of hospitals experienced at least one challenge to electronic public health reporting.

HIN’s and NIEs each have limitations, which are being addressed through the Trusted Exchange Framework and Common Agreement (TEFCA). TEFCA simplifies network participation by providing a way for healthcare providers, health plans, and patients to make a single connection to access EHI on a nationwide scale, and TEFCA supports a broader range of exchange purposes, including treatment, payment, healthcare operations, public health, government benefits determination, and individual access services.

ONC published version 1.1. of TEFCA in November 2023, and in December, five organizations completed the TEFCA onboarding process and were officially designated as Qualified Health Information Networks (QHINs), and a further two organizations were designated as QHINs in February 2024.

ONC anticipates more organizations will be designated as QHINs in the coming year and reports that most hospitals are aware of TEFCA and plan to participate. ONC expects TEFCA will scale significantly and will create a pathway for modern information sharing and patients will experience the benefits, especially those that have multiple healthcare providers as it will make it much easier to efficiently access and manage their own health information, although virtually everyone that uses the healthcare system will benefit from connected HINs eventually, said ONC.

ONC thanked Congress for its commitment to the 21st Century Cures Act, which envisioned TEFCA, and recommended support for the implementation of the health IT provisions of the Cures Act.

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Healthcare Data Breach Statistics

The HIPAA Journal has compiled healthcare data breach statistics from October 2009, when the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) started publishing summaries of healthcare data breaches on its website.

HIPAA Compliance Checklist To Avoid HIPAA BreachesThis page is regularly updated to reflect the latest healthcare data breach statistics. These statistics and graphs were last updated on August 27, 2025, and are based on data obtained from OCR up to and including July 31, 2025.  Check back regularly to get the latest healthcare data breach statistics and healthcare data breach trends. You can view our 2024 healthcare data breach report here. You can also receive a free copy of our HIPAA Compliance Checklist to understand your organization’s responsibilities under HIPAA.

Trends In Healthcare Data Breach Statistics

Our healthcare data breach statistics clearly show there has been an upward trend in data breaches over the past 14 years, with 2021 seeing more data breaches reported than any other year since records first started being published by OCR.

Data breaches increased once again in 2022, with OCR receiving reports of 720 data breaches of 500 or more records. There was no letup in cyberattacks on healthcare organizations in 2023, which set two new records: The most reported data breaches and the most breached records. In 2023, 725 data breaches were reported to OCR, and across those breaches, more than 133 million records were exposed or impermissibly disclosed.

The healthcare data breach statistics below only include data breaches of 500 or more records that have been reported to OCR, as while HIPAA requires all data breaches to be reported regardless of size, OCR does not publish details of smaller data breaches. The breaches included in the statistics and graphs below include closed cases and breaches that are still being investigated by OCR for potential HIPAA violations.

Avoid HIPAA Breaches with HIPAA Compliance SoftwareBetween October 21, 2009, when OCR first started publishing summaries of data breach reports on its “Wall of Shame”, and December 31, 2023, 5,887 large healthcare data breaches have been reported. On January 22, 2023, the breach portal listed 857 data breaches as still under investigation. This time last year, there were 882 breaches listed as under investigation, which shows OCR has made little progress in clearing its backlog of investigations – something that is unlikely to change given the chronic lack of funding for the department.

There have been notable changes over the years in the main causes of breaches. The loss/theft of healthcare records and electronic protected health information dominated the breach reports between 2009 and 2015. The move to digital record keeping, more accurate tracking of electronic devices, and more widespread adoption of data encryption have been key in reducing these data breaches. There has also been a downward trend in improper disposal incidents and unauthorized access/disclosure incidents, but data breaches continue to increase due to a massive increase in hacking incidents and ransomware attacks. In 2023, OCR reported a 239% increase in hacking-related data breaches between January 1, 2018, and September 30, 2023, and a 278% increase in ransomware attacks over the same period. In 2019, hacking accounted for 49% of all reported breaches. In 2023, 79.7% of data breaches were due to hacking incidents.

It is not just the number of data breaches that is increasing, as the breaches are becoming more severe. 2021 was a bad year for data breaches, with 45.9 million records breached, and 2022 was worse with 51.9 million records breached, but 2023 smashed all previous records with an astonishing 168 million records exposed, stolen, or otherwise impermissibly disclosed. The huge total for 2023 includes 26 data breaches of more than 1 million records and four breaches of more than 8 million records. The largest data breach of the year affected 11,270,000 individuals – the second-largest healthcare data breach of all time.

There appears to have been a slight reduction in healthcare data breaches in 2024, although it is a little too early to tell, as OCR has yet to add all reported data breaches for last year to the data breach portal. While healthcare data breaches are down, the number of compromised records has increased again from last year’s record-breaking total to more than 276 million breached records, including the largest-ever healthcare data breach – the ransomware attack at Change Healthcare, which affected an estimated 190 million individuals.

The breach data is updated at least monthly, with the previous month’s figures typically added around the 21st of each month, so check back frequently to see the emerging trends for the current year.

The Biggest U.S. Healthcare Data Breaches of All Time

Rank Year Name of HIPAA-Regulated Entity State Entity Type Individuals Affected Type of Breach
1 2024 Change Healthcare, Inc. MN Business Associate 192,700,000 Hacking/IT Incident
2 2015 Anthem Inc. IN Health Plan 78,800,000 Hacking/IT Incident
3 2023 Welltok, Inc. CO Business Associate 14,782,887 Hacking/IT Incident
4 2024 Kaiser Foundation Health Plan, Inc. CA Health Plan 13,400,000 Unauthorized Access/Disclosure
5 2019 Optum360, LLC MN Business Associate 11,500,000 Hacking/IT Incident
6 2023 HCA Healthcare TN Business Associate 11,270,000 Hacking/IT Incident
7 2015 Premera Blue Cross WA Health Plan 11,000,000 Hacking/IT Incident
8 2019 Laboratory Corporation of America Holdings dba LabCorp NC Healthcare Provider 10,251,784 Hacking/IT Incident
9 2015 Excellus Health Plan, Inc. NY Health Plan 9,358,891 Hacking/IT Incident
10 2023 Perry Johnson & Associates, Inc. dba PJ&A NV Business Associate 9,302,588 Hacking/IT Incident
11 2023 Maximus, Inc. VA Business Associate 9,179,390 Hacking/IT Incident
12 2023 Managed Care of North America GA Business Associate 8,627,242 Hacking/IT Incident
13 2014 Community Health Systems Professional Services Corporations TN Healthcare Provider 6,121,158 Hacking/IT Incident
14 2023 PharMerica Corporation KY Healthcare Provider 5,815,591 Hacking/IT Incident
15 2025 Yale New Haven Health System CT Healthcare Provider 5,556,702 Hacking/IT Incident
16 2024 Ascension Health MO Healthcare Provider 5,466,931 Hacking/IT Incident
17 2025 Episource, LLC CA Business Associate 5,418,866 Hacking/IT Incident
18 2011 Science Applications International Corporation (SA VA Business Associate 4,900,000 Loss
19 2023 HealthEC LLC NJ Business Associate 4,786,241 Hacking/IT Incident
20 2025 Blue Shield of California CA Business Associate 4,700,000 Hacking/IT Incident
21 2015 University of California, Los Angeles Health CA Healthcare Provider 4,500,000 Hacking/IT Incident
22 2014 Community Health Systems Professional Services Corporation TN Business Associate 4,500,000 Theft
23 2024 HealthEquity, Inc. UT Business Associate 4,300,000 Hacking/IT Incident
24 2022 Independent Living Systems, LLC FL Business Associate 4,226,508 Hacking/IT Incident
25 2023 Reventics, LLC FL Business Associate 4,212,823 Hacking/IT Incident
26 2021 20/20 Eye Care Network, Inc FL Business Associate 4,142,440 Hacking/IT Incident
27 2022 OneTouchPoint, Inc. WI Business Associate 4,112,892 Hacking/IT Incident
28 2023 Colorado Department of Health Care Policy & Financing CO Health Plan 4,091,794 Hacking/IT Incident
29 2013 Advocate Health and Hospitals Corporation, d/b/a Advocate Medical Group IL Healthcare Provider 4,029,530 Theft
30 2024 Concentra Health Services, Inc. TX Healthcare Provider 3,998,163 Hacking/IT Incident
31 2016 Banner Health AZ Healthcare Provider 3,620,000 Hacking/IT Incident
32 2021 Florida Healthy Kids Corporation FL Health Plan 3,500,000 Hacking/IT Incident
33 2015 Medical Informatics Engineering IN Business Associate 3,500,000 Hacking/IT Incident
34 2016 Newkirk Products, Inc. NY Business Associate 3,466,120 Hacking/IT Incident
35 2023 Regal Medical Group,Lakeside Medical Organization, ADOC Acquisition, & Greater Covina Medical Group CA Healthcare Provider 3,388,856 Hacking/IT Incident
36 2020 Trinity Health MI Business Associate 3,320,726 Hacking/IT Incident
37 2023 CareSource OH Business Associate 3,180,537 Hacking/IT Incident
38 2023 Cerebral, Inc DE Business Associate 3,179,835 Unauthorized Access/Disclosure
39 2024 Centers for Medicare & Medicaid Services MD Health Plan 3,112,815 Hacking/IT Incident
40 2023 NationsBenefits Holdings, LLC FL Business Associate 3,099,502 Hacking/IT Incident
41 2022 Advocate Aurora Health WI Healthcare Provider 3,000,000 Unauthorized Access/Disclosure
42 2019 Dominion Dental Services, Inc., Dominion National Insurance Company, and Dominion Dental Services USA, Inc. VA Health Plan 2,964,778 Hacking/IT Incident
43 2021 Lincare Holdings Inc. FL Healthcare Provider 2,918,444 Hacking/IT Incident
44 2024 Acadian Ambulance Service, Inc. LA Healthcare Provider 2,896,985 Hacking/IT Incident
45 2022 Connexin Software, Inc. PA Business Associate 2,846,039 Hacking/IT Incident
46 2023 Navvis & Company, LLC MO Business Associate 2,824,726 Hacking/IT Incident
47 2024 A&A Services d/b/a Sav-Rx NE Business Associate 2,812,336 Hacking/IT Incident
48 2023 ESO Solutions, Inc. TX Business Associate 2,700,000 Hacking/IT Incident
49 2025 DaVita Inc. CO Healthcare Provider 2,689,826 Hacking/IT Incident
50 2023 Harvard Pilgrim Health Care MA Health Plan 2,662,337 Hacking/IT Incident
51 2018  AccuDoc Solutions, Inc. NC Business Associate 2,652,537 Hacking/IT Incident
52 2021 NEC Networks, LLC d/b/a CaptureRx TX Business Associate 2,600,000 Hacking/IT Incident
53 2021 Smile Brands, Inc. CA Business Associate 2,592,494 Hacking/IT Incident
54 2024 WebTPA Employer Services, LLC (“WebTPA”) TX Business Associate 2,518,533 Hacking/IT Incident
55 2023 Norton Healthcare Inc. KY Healthcare Provider 2,500,000 Hacking/IT Incident
56 2023 Enzo Clinical Labs, Inc. NY Healthcare Provider 2,470,000 Hacking/IT Incident
57 2023 Florida Health Sciences Center, Inc. dba Tampa General Hospital FL Healthcare Provider 2,430,920 Hacking/IT Incident
58 2021 Forefront Dermatology, S.C. WI Healthcare Provider 2,413,553 Hacking/IT Incident
59 2024 INTEGRIS Health OK Healthcare Provider 2,385,646 Hacking/IT Incident
60 2022 Shields Health Care Group, Inc. MA Business Associate 2,380,483 Hacking/IT Incident
61 2023 Postmeds, Inc. CA Healthcare Provider 2,364,359 Hacking/IT Incident
62 2023 Centers for Medicare & Medicaid Services MD Health Plan 2,342,357 Hacking/IT Incident
63 2024 Medical Management Resource Group, L.L.C. AZ Business Associate 2,264,157 Hacking/IT Incident
64 2016 21st Century Oncology FL Healthcare Provider 2,213,597 Hacking/IT Incident
65 2023 McLaren Health Care MI Healthcare Provider 2,103,881 Hacking/IT Incident
66 2023 Berry, Dunn, McNeil & Parker, LLC ME Business Associate 2,068,426 Hacking/IT Incident
67 2014 Xerox State Healthcare, LLC TX Business Associate 2,000,000 Unauthorized Access/Disclosure
68 2023 Arietis Health, LLC FL Business Associate 1,975,066 Hacking/IT Incident
69 2023 Great Expressions Dental Centers MI Healthcare Provider 1,925,397 Hacking/IT Incident
70 2022 Professional Finance Company, Inc. CO Business Associate 1,918,941 Hacking/IT Incident
71 2025 Anne Arundel Dermatology MD Healthcare Provider 1,905,000 Hacking/IT Incident
72 2011 IBM NY Business Associate 1,900,000 Unknown
73 2022 Apria Healthcare LLC IN Healthcare Provider 1,868,831 Hacking/IT Incident
74 2023 Pension Benefit Information, LLC MN Business Associate 1,866,694 Hacking/IT Incident
75 2023 Fred Hutchinson Cancer Center WA Healthcare Provider 1,840,927 Hacking/IT Incident
76 2024 Summit Pathology and Summit Pathology Laboratories, Inc. CO Healthcare Provider 1,813,538 Hacking/IT Incident
77 2023 Performance Health Technology OR Business Associate 1,752,076 Hacking/IT Incident
78 2023 NASCO GA Business Associate 1,744,655 Hacking/IT Incident
79 2024 OnePoint Patient Care AZ Healthcare Provider 1,741,152 Hacking/IT Incident
80 2019 Clinical Pathology Laboratories, Inc. TX Healthcare Provider 1,733,836 Hacking/IT Incident
81 2020 Dental Care Alliance, LLC FL Business Associate 1,723,375 Hacking/IT Incident
82 2011 GRM Information Management Services NJ Business Associate 1,700,000 Theft
83 2022 Baptist Medical Center TX Healthcare Provider 1,608,549 Hacking/IT Incident
84 2019 Inmediata Health Group PR Healthcare Clearing House 1,565,338 Unauthorized Access/Disclosure
85 2021 Eskenazi Health IN Healthcare Provider 1,515,918 Hacking/IT Incident
86 2022 Community Health Network, Inc. as an Affiliated Covered Entity IN Healthcare Provider 1,500,000 Unauthorized Access/Disclosure

Healthcare Data Breaches by Year

Between 2009 and 2024, 6,759 healthcare data breaches of 500 or more records were reported to OCR. Those breaches have resulted in the exposure or impermissible disclosure of the protected health information of 846,962,011 individuals. That equates to more than 2.6x the population of the United States. In 2018, healthcare data breaches of 500 or more records were being reported at a rate of around 1 per day. Fast forward 5 years, and the rate has more than doubled. In 2023, an average of 1.99 healthcare data breaches of 500 or more records were reported each day, and on average, 364,571 healthcare records were breached every day. While similar numbers of healthcare data breaches were reported in 2024, the number of individuals affected by those breaches has increased significantly. In 2024, the protected health information of 276,775,457 individuals was exposed or stolen. On average, that is 758,288 records per day!

healthcare data breaches of 500 or more records 2009-2025

Healthcare Records Exposed by Year

Records compromised in U.S. healthcare data breaches 2009-2025

There has been a general upward trend in the number of records exposed each year, with a massive increase in 2015. Until 2023, 2015 was the worst year in history for breached healthcare records, with more than 112 million records exposed or impermissibly disclosed. 2015 was particularly bad due to three massive data breaches at health plans: Anthem Inc., Premera Blue Cross, and Excellus. The Anthem breach affected 78.8 million of its members, with the Premera Blue Cross and Excellus data breaches both affecting around 10 million+ individuals. Those data breaches are small in comparison to the data breach at Change Healthcare in 2024, which affected an estimated 190 million individuals. The second-largest data breach of 2024 was reported by Kaiser Foundation Health Plan and affected 13.4 million individuals.

Average/Median Healthcare Data Breach Size by Year

Healthcare data breaches - average breach size 2009-2025

Healthcare data breaches - median breach size 2009-2025

Largest Healthcare Data Breaches (2009 – 2024)

The largest healthcare data breach occurred at Anthem Inc. in 2015 and involved the records of 78.8 million individuals. A data breach as large as that seemed unlikely to occur again, but this year that record has been smashed. A ransomware attack on Change Healthcare has resulted in the theft of the protected health information of 190 million individuals.  You can read more about this devastating cyberattack in this article.

* PJ&A reported the data breach to OCR as affecting 8,952,212 individuals, but some of its covered entity clients reported the data breach themselves. In total, more than 13 million individuals are known to have been affected by the PJ&A data breach.

These figures are calculated based on the reporting entity. When a data breach occurs at a business associate, it may be reported by the business associate or by each affected HIPAA-covered entity. For instance, in 2022, the electronic health record provider Eye Care Leaders suffered a ransomware attack. Each covered entity reported the breach separately. The HIPAA Journal has tracked the breach reports, and at least 39 HIPAA-covered entities were affected, and the records of more than 3.09 million individuals were exposed. Similarly, a major data breach occurred at American Medical Collection Agency in 2019 that was reported by each covered entity, rather than AMCA. That breach affected more than 25 million individuals. Even when business associates of HIPAA-covered entities self-report the data breaches, some of their covered entity clients choose to report the breach themselves. As a result, business associate data breaches tend to be under-represented in analyses of healthcare data breaches.

Causes of Healthcare Data Breaches

causes of healthcare security breaches 2009-2025

exposed, stolen and impermissibly disclosed healthcare records 2009-2024

Healthcare Hacking Incidents by Year

Our healthcare data breach statistics show hacking is now the leading cause of healthcare data breaches, although it should be noted that healthcare organizations are now much better at detecting hacking incidents than they were in 2010. The low number of hacking/IT incidents in the earlier years could be partially due to the failure to detect hacking incidents and malware infections, although it is clear that there has been a massive increase in attacks in recent years. Many of the hacking incidents between 2014 and 2018 occurred many months – and in some cases, years – before they were detected.

Hacking incidents in healthcare 2009-2025

healthcare hacking incidents 2009-2025 - records compromised

Unauthorized Access/Disclosures by Year

As with hacking, healthcare organizations are getting better at detecting insider breaches and reporting those breaches to the Office for Civil Rights, although as the chart below shows, the severity of these breaches has increased significantly in recent years. These incidents include employee errors, negligence, snooping on medical records, and data theft by malicious insiders. Better HIPAA and security awareness training, along with the use of technologies for monitoring access to medical records, are helping to reduce these data breaches.

Unauthorized access/disclosure incidents in healthcare 2009-2025

Unauthorized access/disclosure incidents in healthcare 2009-2025 - records compromised

Loss/Theft of PHI and Unencrypted ePHI by Year

Our healthcare data breach statistics show that HIPAA-covered entities and business associates have gotten significantly better at protecting healthcare records with administrative, physical, and technical controls such as encryption, although unencrypted laptops and other electronic devices are still being left unsecured in vehicles and locations accessible by the public. Many of these theft/loss incidents involve paper records, which can equally result in the exposure of large amounts of patient information.

Loss and theft incidents in healthcare 2009-2025

healthcare loss/theft incidents 2009-2025 - records compromised

Improper Disposal of PHI/ePHI by Year

HIPAA requires healthcare data, whether in physical or electronic form, to be permanently destroyed when no longer required. The improper disposal of PHI is a relatively infrequent breach cause and typically involves paper records that have not been sent for shredding or have been abandoned.

Improper disposal incidents in healthcare 2009-2025

healthcare improper disposal incidents 2009-2025 - records compromised

Healthcare Data Breaches by HIPAA-Regulated Entity Type

The table below shows the raw data from OCR of the data breaches by the entity reporting the breaches; however, this data does not tell the whole story, as data breaches occurring at business associates may be reported by the business associate or each affected covered entity or a combination of the two. Many online reports that provide healthcare data breach statistics fail to accurately reflect where many data breaches are occurring.

Healthcare Data Breaches: Reporting Entity (2009 – 2025)

Year Healthcare Provider Health Plan Business Associate Healthcare Clearinghouse Total
2009 14 1 3 0 18
2010 134 21 44 0 199
2011 135 19 45 1 200
2012 154 23 40 1 218
2013 191 20 64 2 277
2014 200 40 74 0 314
2015 195 61 14 0 270
2016 256 50 22 0 328
2017 285 52 21 0 358
2018 274 53 42 0 369
2019 396 59 54 2 511
2020 514 73 74 2 663
2021 516 104 93 2 715
2022 504 86 129 0 719
2023 469 103 172 2 746
2024 538 77 118 3 736
2025 334 30 78 2 444
Total 5,109 872 1,087 17 7,085

The graphs below paint a more accurate picture of where healthcare data breaches are occurring, rather than the entities that have reported the data breaches, and clearly show the extent to which business associate data breaches have increased in recent years. In 2023, more than 93 million healthcare records were exposed or stolen in data breaches at business associates compared to 34.9 million records in breaches at healthcare providers. The charts below show data breaches by reporting entity.

Data breaches at HIPAA-regulated entities 2009-2025

breached records at HIPAA-regulated entities 2009-2025

These data highlight the importance of securing the supply chain, conducting due diligence on vendors before their products and services are used, and monitoring existing vendors for HIPAA Security Rule compliance and cybersecurity. In 2023, one of the biggest challenges in healthcare cybersecurity is securing the supply chain.

OCR Settlements and Fines for HIPAA Violations

The penalties for HIPAA violations can be severe. Multi-million-dollar fines are possible when violations have been allowed to persist for several years or when there is systemic non-compliance with the HIPAA Rules, making HIPAA compliance financially as well as ethically important.

The penalty structure for HIPAA violations is detailed in the infographic below. These figures are adjusted annually for inflation. The current penalty amounts can be found here.

Penalties for HIPAA violations

OCR Settlements and Fines Over the Years

Further information on HIPAA fines and settlements can be viewed on our HIPAA violation fines page, which details all HIPAA violation fines imposed by OCR since 2008. As the graph below shows, HIPAA enforcement activity has steadily increased over the past 14 years, with 2022 being a record year, with 22 penalties imposed. The major rise in HIPAA violation penalties in 2020 was largely due to a new enforcement initiative by OCR targeting non-compliance with the HIPAA Right of Access – the right of patients to access and obtain a copy of their healthcare data. 11 settlements were reached with healthcare providers in 2020 to resolve cases where patients were not given timely access to their medical records, and in 2021, all but two of the 14 penalties were for HIPAA Right of Access violations. From September 2019 to December 2023, 46 penalties have been imposed to resolve HIPAA Right of Access violations.

There was an increase in HIPAA enforcement activity in 2024, as while OCR only announced 16 civil monetary penalties and settlements in 2024 to resolve alleged HIPAA violations, OCR Director Melanie Fontes Rainer explained that OCR had in fact closed 22 HIPAA investigations with financial penalties, although OCr announced six of those HIPAA cases in early January 2024 before the administration change. The high level of HIPAA enforcement has continued in 2025, largely due to the new HIPAA risk analysis enforcement initiative. Under this initiative, OCR is focused on compliance with the risk analysis provision of the HIPAA Security Rule – the most commonly identified HIPAA Security Rule violation. By focusing on this aspect of Security Rule compliance, OCR is able to complete investigations more quickly, helping to reduce the large backlog of data breach cases, while also holding HIPAA-regulated entities to account for risk analysis failures. As of May 31, 2025, OCR has closed 9 investigations with financial penalties for HIPAA risk analysis failures under this enforcement initiative.

OCR penalties for HIPAA violations 2009-2025

How Much Has OCR Fined HIPAA Covered Entities and Business Associates?

In addition to an increase in fines and settlements, penalty amounts increased considerably between 2015 and 2018. In 2018, the largest ever financial penalty for HIPAA violations was paid by Anthem Inc. to resolve potential violations of the HIPAA Security Rule that were discovered by OCR during the investigation of its 78.8 million record data breach in 2015. Anthem paid $16 million to settle the case. In 2020, Premera Blue Cross settled potential violations of the HIPAA Rules and paid a $6,850,000 penalty to resolve its 2015 data breach of the PHI of almost 10.5 million individuals, and in 2021 a $5,000,000 settlement was agreed upon with Excellus Health Plan to resolve HIPAA violations identified that contributed to its 2015 data breach of the PHI of almost 9.4 million individuals.

While large financial penalties are still imposed to resolve HIPAA violations, the trend has been for smaller penalties to be issued in recent years, with those penalties imposed on healthcare organizations of all sizes. It is no longer the case that smaller healthcare organizations escape HIPAA fines. In 2022, 55% of the financial penalties imposed by OCR were on small medical practices.

The fall in revenues from OCR’s enforcement activities in recent years is due to OCR reassessing the language of the HITECH Act, which called for penalties for HIPAA violations to be increased. OCR determined that the language of the HITECH Act had been misinterpreted at the time and reduced the penalty caps in three of the four penalty tiers. OCR is now petitioning Congress to increase the penalty caps to increase the deterrent effect.

Funds raised by OCR enforcement actions (2008-2025)

Average HIPAA penalty (2008-2025)

Median HIPAA penalty (2008-2025)

It was expected that 2018 would see fewer fines for HIPAA-covered entities than in the past two years due to HHS budget cuts, but that did not prove to be the case. 2018 was a record-breaking year for HIPAA fines and settlements, beating the previous record of $23,505,300 set in 2016 by 22%. OCR received payments totaling $28,683,400 in 2018 from HIPAA-covered entities and business associates who had violated HIPAA Rules, and 2020 saw a major increase in enforcement activity with 19 settlements. The number of financial penalties was reduced in 2021; however, 2022 saw penalties increase, with 22 financial penalties announced by OCR, more than in any other year to date. There was a reduction in enforcement actions in 2023, although there was an increase in penalty amounts. OCR had been concentrating on HIPAA Right of Access violations, for which the penalties are generally relatively low, as only one HIPAA provision is typically violated. In 2023, OCR imposed more fines for HIPAA Security Rule violations, where the entity concerned violated multiple aspects of the Security Rule, hence the higher penalties.

In 2024, OCR closed 22 HIPAA investigations with financial penalties, although only 16 were announced in 2024. The remainder were announced by OCR in early January 2025, and the high level of enforcement activity has continued in 2025, with this year looking like it will be a record year for HIPAA enforcement. More detailed information on these settlements and civil monetary penalties can be found on our HIPAA Violation Cases page.

OCR Penalties for HIPAA Violations (2008 – 2025)

Year Covered Entity Amount Penalty Type
2025 BST & Co. CPAs, LLP $175,000 Settlement
2025 Syracuse ASC (Specialty Surgery Center of Central New York) $250,000 Settlement
2025 Deer Oaks – The Behavioral Health Solution $225,000 Settlement
2025 Comstar LLC $75,000 Settlement
2025 BayCare Health System $800,000 Settlement
2025 Vision Upright MRI $5,000 Settlement
2025 Comprehensive Neurology $25,000 Settlement
2025 PIH Health $600,000 Settlement
2025 Guam Memorial Hospital Authority $25,000 Settlement
2025 Northeast Radiology $350,000 Settlement
2025 Health Fitness Corporation $227,816 Settlement
2025 Oregon Health & Science University $200,000 Civil Monetary Penalty
2025 Warby Parker Inc. $1,500,000 Civil Monetary Penalty
2025 Northeast Surgical Group $10,000 Settlement
2025 South Broward Hospital District (Memorial Health System) $60,000 Settlement
2025 Solara Medical Supplies $3,000,000 Settlement
2025 USR Holdings $337,750 Settlement
2025 Virtual Private Network Solutions $90,000 Settlement
2025 Elgon Information Systems $80,000 Settlement
2024 Inmediata Health Group $250,000 Settlement
2024 Children’s Hospital Colorado Health System $548,265 Civil Monetary Penalty
2024 Gulf Coast Pain Consultants, dba Clearway Pain Solutions Institute $1,190,000 Civil Monetary Penalty
2024 Holy Redeemer Family Medicine $35,581 Settlement
2024 Rio Hondo Community Mental Health Center $100,000 Civil Monetary Penalty
2024 Bryan County Ambulance Authority $90,000 Settlement
2024 Plastic Surgery Associates of South Dakota $500,000 Settlement
2024 Gums Dental Care $70,000 Civil Monetary Penalty
2024 Providence Medical Institute $240,000 Civil Monetary Penalty
2024 Cascade Eye and Skin Centers $250,000 Settlement
2024 American Medical Response $115,200 Civil Monetary Penalty
2024 Heritage Valley Health System $950,000 Settlement
2024 Essex Residential Care (Hackensack Meridian Health, West Caldwell Care Center) $100,000 Civil Monetary Penalty
2024 Phoenix Healthcare $35,000 Settlement
2024 Green Ridge Behavioral Health $40,000 Settlement
2024 Montefiore Medical Center $4,750,000 Settlement
2023 Optum Medical Care of New Jersey $160,000 Settlement
2023 Lafourche Medical Group $480,000 Settlement
2023 St. Joseph’s Medical Center $80,000 Settlement
2023 Doctors’ Management Services $100,000 Settlement
2023 L.A. Care Health Plan $1,300,000 Settlement
2023 UnitedHealthcare $80,000 Settlement
2023 iHealth Solutions (dba Advantum Health) $75,000 Settlement
2023 Yakima Valley Memorial Hospital $240,000 Settlement
2023 Manasa Health Center, LLC $30,000 Settlement
2023 MedEvolve Inc. $350,000 Settlement
2023 David Mente, MA, LPC $15,000 Settlement
2023 Banner Health $1,250,000 Settlement
2023 Life Hope Labs, LLC $16,500 Settlement
2022 Health Specialists of Central Florida Inc $20,000 Settlement
2022 New Vision Dental $23,000 Settlement
2022 Great Expressions Dental Center of Georgia, P.C. $80,000 Settlement
2022 Family Dental Care, P.C. $30,000 Settlement
2022 B. Steven L. Hardy, D.D.S., LTD, dba Paradise Family Dental $25,000 Settlement
2022 New England Dermatology and Laser Center $300,640 Settlement
2022 ACPM Podiatry $100,000 Civil Monetary Penalty
2022 Memorial Hermann Health System $240,000 Settlement
2022 Southwest Surgical Associates $65,000 Settlement
2022 Hillcrest Nursing and Rehabilitation $55,000 Settlement
2022 MelroseWakefield Healthcare $55,000 Settlement
2022 Erie County Medical Center Corporation $50,000 Settlement
2022 Fallbrook Family Health Center $30,000 Settlement
2022 Associated Retina Specialists $22,500 Settlement
2022 Coastal Ear, Nose, and Throat $20,000 Settlement
2022 Lawrence Bell, Jr. D.D.S $5,000 Settlement
2022 Danbury Psychiatric Consultants $3,500 Settlement
2022 Oklahoma State University – Center for Health Sciences $875,000 Settlement
2022 Dr. Brockley $30,000 Settlement
2022 Jacob & Associates $28,000 Settlement
2022 Dr. U. Phillip Igbinadolor, D.M.D. & Associates, P.A. $50,000 Civil Monetary Penalty
2022 Northcutt Dental-Fairhope $62,500 Settlement
2021 Advanced Spine & Pain Management $32,150 Settlement
2021 Denver Retina Center $30,000 Settlement
2021 Dr. Robert Glaser $100,000 Civil Monetary Penalty
2021 Rainrock Treatment Center LLC (dba monte Nido Rainrock) $160,000 Settlement
2021 Wake Health Medical Group $10,000 Settlement
2021 Children’s Hospital & Medical Center $80,000 Settlement
2021 The Diabetes, Endocrinology & Lipidology Center, Inc. $5,000 Settlement
2021 AEON Clinical Laboratories (Peachstate) $25,000 Settlement
2021 Village Plastic Surgery $30,000 Settlement
2021 Arbour Hospital $65,000 Settlement
2021 Sharpe Healthcare $70,000 Settlement
2021 Renown Health $75,000 Settlement
2021 Excellus Health Plan $5,100,000 Settlement
2021 Banner Health $200,000 Settlement
2020 Peter Wrobel, M.D., P.C., dba Elite Primary Care $36,000 Settlement
2020 University of Cincinnati Medical Center $65,000 Settlement
2020 Dr. Rajendra Bhayani $15,000 Settlement
2020 Riverside Psychiatric Medical Group $25,000 Settlement
2020 City of New Haven, CT $202,400 Settlement
2020 Aetna $1,000,000 Settlement
2020 NY Spine $100,000 Settlement
2020 Dignity Health, dba St. Joseph’s Hospital and Medical Center $160,000 Settlement
2020 Premera Blue Cross $6,850,000 Settlement
2020 CHSPSC LLC $2,300,000 Settlement
2020 Athens Orthopedic Clinic PA $1,500,000 Settlement
2020 Housing Works, Inc. $38,000 Settlement
2020 All Inclusive Medical Services, Inc. $15,000 Settlement
2020 Beth Israel Lahey Health Behavioral Services $70,000 Settlement
2020 King MD $3,500 Settlement
2020 Wise Psychiatry, PC $10,000 Settlement
2020 Lifespan Health System Affiliated Covered Entity $1,040,000 Settlement
2020 Metropolitan Community Health Services dba Agape Health Services $25,000 Settlement
2020 Steven A. Porter, M.D $100,000 Settlement
2019 Jackson Health System $2,154,000 Civil Monetary Penalty
2019 Texas Department of Aging and Disability Services $1,600,000 Civil Monetary Penalty
2019 University of Rochester Medical Center $3,000,000 Settlement
2019 Touchstone Medical imaging $3,000,000 Settlement
2019 Sentara Hospitals $2,175,000 Settlement
2019 Medical Informatics Engineering $100,000 Settlement
2019 Korunda Medical, LLC $85,000 Settlement
2019 Bayfront Health St. Petersburg $85,000 Settlement
2019 West Georgia Ambulance $65,000 Settlement
2019 Elite Dental Associates $10,000 Settlement
2018* University of Texas MD Anderson Cancer Center $4,348,000 Civil Monetary Penalty
2018 Anthem Inc $16,000,000 Settlement
2018 Fresenius Medical Care North America $3,500,000 Settlement
2018 Massachusetts General Hospital $515,000 Settlement
2018 Brigham and Women’s Hospital $384,000 Settlement
2018 Boston Medical Center $100,000 Settlement
2018 Filefax, Inc. $100,000 Settlement
2017 Children’s Medical Center of Dallas $3,200,000 Civil Monetary Penalty
2017 Memorial Healthcare System $5,500,000 Settlement
2017 Cardionet $2,500,000 Settlement
2017 Memorial Hermann Health System $2,400,000 Settlement
2017 21st Century Oncology $2,300,000 Settlement
2017 MAPFRE Life Insurance Company of Puerto Rico $2,200,000 Settlement
2017 Presense Health $475,000 Settlement
2017 Metro Community Provider Network $400,000 Settlement
2017 St. Luke’s-Roosevelt Hospital Center Inc. $387,000 Settlement
2017 The Center for Children’s Digestive Health $31,000 Settlement
2016 Lincare, Inc. $239,800 Civil Monetary Penalty
2016 Advocate Health Care Network $5,550,000 Settlement
2016 Feinstein Institute for Medical Research $3,900,000 Settlement
2016 University of Mississippi Medical Center $2,750,000 Settlement
2016 Oregon Health & Science University $2,700,000 Settlement
2016 New York Presbyterian Hospital $2,200,000 Settlement
2016 St. Joseph Health $2,140,500 Settlement
2016 North Memorial Health Care of Minnesota $1,550,000 Settlement
2016 Raleigh Orthopaedic Clinic, P.A. of North Carolina $750,000 Settlement
2016 University of Massachusetts Amherst (UMass) $650,000 Settlement
2016 Catholic Health Care Services of the Archdiocese of Philadelphia $650,000 Settlement
2016 Care New England Health System $400,000 Settlement
2016 Complete P.T., Pool & Land Physical Therapy, Inc. $25,000 Settlement
2015 Triple S Management Corporation $3,500,000 Settlement
2015  Lahey Hospital and Medical Center $850,000 Settlement
2015 University of Washington Medicine $750,000 Settlement
2015 Cancer Care Group, P.C. $750,000 Settlement
2015 St. Elizabeth’s Medical Center $218,400 Settlement
2015 Cornell Prescription Pharmacy $125,000 Settlement
2014 New York and Presbyterian Hospital and Columbia University $4,800,000 Settlement
2014 Concentra Health Services $1,725,220 Settlement
2014 Parkview Health System, Inc. $800,000 Settlement
2014 QCA Health Plan, Inc., of Arkansas $250,000 Settlement
2014 Skagit County, Washington $215,000 Settlement
2014 Anchorage Community Mental Health Services $150,000 Settlement
2013 WellPoint $1,700,000 Settlement
2013 Affinity Health Plan, Inc. $1,215,780 Settlement
2013 Idaho State University $400,000 Settlement
2013 Shasta Regional Medical Center $275,000 Settlement
2013 Adult & Pediatric Dermatology, P.C. $150,000 Settlement
2012 Alaska DHSS $1,700,000 Settlement
2012 Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates, Inc. $1,500,000 Settlement
2012 Blue Cross Blue Shield of Tennessee $1,500,000 Settlement
2012 Phoenix Cardiac Surgery $100,000 Settlement
2012 The Hospice of Northern Idaho $50,000 Settlement
2011 Cignet Health of Prince George’s County $4,300,000 Civil Monetary Penalty
2011 General Hospital Corp. & Massachusetts General Physicians Organization Inc. $1,000,000 Settlement
2011 University of California at Los Angeles Health System $865,500 Settlement
2010 Rite Aid Corporation $1,000,000 Settlement
2010 Management Services Organization Washington Inc. $35,000 Settlement
2009 CVS Pharmacy Inc. $2,250,000 Settlement
2008 Providence Health & Services $100,000 Settlement

*In 2021, following an appeal, the civil monetary penalty imposed on the University of Texas MD Anderson Cancer Center by the HHS’ Office for Civil Rights was vacated.

State Attorneys General HIPAA Fines and Other Financial Penalties for Healthcare Organizations

State attorneys general can bring actions against HIPAA-covered entities and their business associates for violations of the HIPAA Rules. Penalties range from $100 per HIPAA violation up to a maximum of $25,000 per violation category, per year.

Only a handful of U.S. states have imposed penalties for HIPAA violations; however, that changed in 2019 when many state Attorneys General started participating in multistate actions against HIPAA-covered entities and business associates that experienced major data breaches and were found not to be in compliance with the HIPAA Rules.

The penalties detailed below have been imposed by state attorneys general for HIPAA violations and violations of state laws. It is common for penalties to be imposed solely for violations of state laws, even though there are corresponding HIPAA violations.

Attorneys General HIPAA Fines (2008 – 2025)

Year State Covered Entity Amount
2024 Indiana Westend Dental $350,000
2024 New York HealthAlliance $1,400,000 ($850,000 suspended)
2024 New York Albany ENT & Allergy Specialists $1,000,000 ($500,000 suspended); $2.25M investment in cybersecurity
2024 New York, New Jersey, Connecticut Enzo Biochem/Enzo Clinical Labs $4,500,000
2024 Washington Allure Esthetic $5,000,000
2024 California Adventist Health Hanford $10,000
2024 California Blackbaud $6,750,000
2024 California Quest Diagnostics $5,000,000
2024 New York Refuah Health Center $450,000 and an investment of $1.2 million in cybersecurity
2023 New York New York Presbyterian Hospital $300,000
2023 New York Healthplex $400,000
2023 Indiana CarePointe ENT $120,000
2023 New York U.S. Radiology Specialists Inc. $450,000
2023 Multistate (32 states and PR) Inmediata $1,400,000
2023 New York Personal Touch Holding Corp $350,000
2023 Multistate (49 states and DC) Blackbaud $49,500,000
2023 Colorado Broomfield Skilled Nursing and Rehabilitation Center $60,000 ($25,000 suspended)
2023 Indiana Schneck Medical Center $250,000
2023 California Kaiser Foundation Health Plan Foundation Inc. and Kaiser Foundation Hospitals $49,000,000
2023 California Kaiser Permanente $450,000
2023 New York Professional Business Systems Inc. dba Practicefirst Medical Management Solutions $550,000
2023 Multi-state: Oregon, New Jersey, Florida, Pennsylvania EyeMed Vision Care $2,500,000
2023 New York Heidell, Pittoni, Murphy & Bach LLP $200,000
2023 Pennsylvania & Ohio DNA Diagnostics Center $400,000
2022 Oregon & Utah Avalon Healthcare $200,000
2022 Massachusetts Aveanna Healthcare $425,000
2022 New York EyeMed Vision Care $600,000
2021 New Jersey Regional Cancer Care Associates (Regional Cancer Care Associates LLC, RCCA MSO LLC, and RCCA MD LLC) $425,000
2021 New Jersey Regional Cancer Care Associates (Regional Cancer Care Associates LLC, RCCA MSO LLC, and RCCA MD LLC) $425,000
2021 New Jersey Diamond Institute for Infertility and Menopause $495,000
2021 Multistate American Medical Collection Agency $21 million (suspended)
2020 Multistate CHSPSC LLC $5,000,000
2020 Multistate Anthem Inc. $39.5 million
2020 California Anthem Inc. $8.7 million
2019 Multistate Premera Blue Cross $10,000,000
2019 Multistate Medical Informatics Engineering $900,000
2019 California Aetna $935,000
2018 Massachusetts McLean Hospital $75,000
2018 New Jersey EmblemHealth $100,000
2018 New Jersey Best Transcription Medical $200,000
2018 Connecticut Aetna $99,959
2018 New Jersey Aetna $365,211.59
2018 District of Columbia Aetna $175,000
2018 Massachusetts UMass Memorial Medical Group / UMass Memorial Medical Center $230,000
2018 New York Arc of Erie County $200,000
2018 New Jersey Virtua Medical Group $417,816
2018 New York EmblemHealth $575,000
2018 New York Aetna $1,150,000
2017 California Cottage Health System $2,000,000
2017 Massachusetts Multi-State Billing Services $100,000
2017 New Jersey Horizon Healthcare Services Inc., $1,100,000
2017 Vermont SAManage USA, Inc. $264,000
2017 New York CoPilot Provider Support Services, Inc $130,000
2015 New York University of Rochester Medical Center $15,000
2015 Connecticut Hartford Hospital/ EMC Corporation $90,000
2014 Massachusetts Women & Infants Hospital of Rhode Island $150,000
2014 Massachusetts Boston Children’s Hospital $40,000
2014 Massachusetts Beth Israel Deaconess Medical Center $100,000
2013 Massachusetts Goldthwait Associates $140,000
2012 MN Accretive Health $2,500,000
2012 Massachusetts South Shore Hospital $750,000
2011 Vermont Health Net Inc. $55,000
2011 Indiana WellPoint Inc. $100,000
2010 Connecticut Health Net Inc. $250,000

Click for further information HIPAA enforcement by State Attorneys General.

Federal Trade Commission Fines and Penalties

In 2009, the Federal Trade Commission (FTC) published a new rule that required vendors of personal health records and related entities to notify consumers following a breach involving unsecured information. The FTC Health Breach Notification Rule applies only to identifying health information that is not covered by HIPAA. The Rule does not apply to HIPAA-covered entities or business associates, which have reporting requirements per the HIPAA Breach Notification Rule.

The FTC issued a policy update in 2021 stating its intention to start actively enforcing compliance. Prior to 2023, no financial penalties had been imposed for breach notification failures but that changed in February 2023.

Entity Company Type Penalty Type Amount Reason
Cerebral Mental health telehealth company Settlement $7.1 million ($10 million CMP, $8 million suspended. $5.1 million in refunds to customers) Impermissible disclosure of personal and health information to third parties such as Google and Snapchat
Monument Alcohol addiction treatment company Settlement $2.5 million (suspended) Impermissible disclosure of personal and health information to third parties such as Google.
Easy Healthcare (Premom) Fertility tracking health app provider Settlement $200,000 Impermissible disclosure of personal and health information to third parties such as Google and Facebook. Failure to issue timely notifications
BetterHelp Inc. Online counseling service provider Settlement $7,800,000 Impermissible disclosure of personal and health information to third parties such as Google and Facebook
GoodRx Holdings Inc. Telemedicine platform provider Settlement $1,500,000 Failure to notify consumers about the impermissible disclosure of personal and health information to third parties such as Google and Facebook

Healthcare Data Breach Statistics FAQs

How does the number of data breaches in the healthcare sector compare with other sectors?

The number of data breaches in the healthcare sector compares poorly with other sectors. An analysis of data breaches recorded on the Privacy Rights database between 2015 and 2022 showed that 32% of all recorded data breaches were in the healthcare sector – almost double the number recorded in the financial and manufacturing sectors.

Top 5 Sector by Cost of Cybersecurity Breaches HIPAAJournal.com

Why are there so many more data breaches in the healthcare sector than in other sectors?

There are so many more data breaches in the healthcare sector than in other sectors because healthcare data is more valuable on the black market than any other type of data. This is because it takes longer for healthcare fraud to be discovered and stolen data can be used for longer compared to (for example) a stolen credit card which can be stopped as soon as the breach is discovered.

It is also the case that organizations in the healthcare sector have stricter breach notification requirements than in other sectors. Certain types of breaches (i.e., ransomware attacks) have to be reported even if it cannot be established data has been compromised. The increasing number of recent ransomware attacks may have influenced the healthcare data breach statistics.

Why has the average HIPAA penalty decreased since 2018 despite increases in the number of breaches and median breach size?

The average HIPAA penalty has decreased since 2018 despite increases in the number of breaches and median breach size because in recent years the Office for Civil Rights (OCR) has been running a right of access initiative to clamp down on providers who fail to provide patients with access to their PHI within the thirty days allowed.

Penalties for right of access failures are less than for high-volume data breaches, and this has resulted in a decrease in the average HIPAA penalty in recent years. However, while the average HIPAA penalty issued by OCR has decreased, penalties issued by State Attorneys General have remained constant, while it is too early to find trends in fines issued by the FTC.

If a healthcare professional discloses PHI without authorization, is this included in the healthcare data breach statistics?

If a healthcare professional discloses PHI without authorization, the disclosure is unlikely to appear in the healthcare data breach statistics because the statistics are compiled from breaches involving 500 or more records. Therefore, individual unauthorized disclosures of PHI are not included in the figures. However, if the unauthorized disclosure is investigated by OCR and found to be attributable to willful neglect, any subsequent fines will be included in the settlement statistics.

How can healthcare organizations mitigate data breaches?

Healthcare organizations can mitigate data breaches using various methods. The most effective is to encrypt protected health information to render it unusable, unreadable, or indecipherable in the event of a data breach attack. This will ensure data is not compromised and the attack will not have to be reported to the Office for Civil Rights.

Other steps include implementing two-factor authentication on privileged accounts to mitigate the consequences of credential theft, running checks on all storage volumes (cloud and on-premises) to ensure appropriate permissions are applied, checking network connections for unauthorized open ports, and eliminating Shadow IT environments developed as workarounds.

How are successful phishing attacks recorded in the HIPAA breach reports?

Successful phishing attacks are recorded in the HIPAA breach reports as Hacking/IT Incidents. However, as other cybersecurity incidents such as ransomware attacks and events attributable to malware are also categorized as Hacking/IT Incidents, it is not possible to determine how many successful phishing attacks there have been affecting more than 500 individuals.

Why doesn’t HHS fine every covered organization when a HIPAA data breach occurs?

HHS doesn’t fine every covered organization when a HIPAA data breach occurs because not all data breaches are attributable to HIPAA violations. For example, successful ransomware attacks are notifiable events even when no PHI is disclosed and when systems can be quickly restored from backups because, for a period of time, PHI was unavailable.

Why is the number of HIPAA breaches increasing despite more awareness about HIPAA compliance?

The number of HIPAA breaches is increasing despite more awareness about HIPAA compliance due to the increasing digitalization of healthcare data and the increasing sophistication of cyberattacks. While there is an argument that more awareness about HIPAA compliance is having an impact on the lower number of HIPAA breaches attributable to lost or stolen drives and devices, there is a counterargument that, because of the increase in cloud computing, fewer covered organizations are transporting unencrypted PHI on drives and devices.

How can HIPAA covered entities better secure their supply chains to prevent data breaches attributable to business associates?

HIPAA covered entities can better secure their supply chains to prevent data breaches attributable to business associates by conducting more thorough due diligence on each business associate. Many covered entities rely on “good faith assurances” rather than investigating the measures each business associate has in place to prevent data breaches, the training provided to business associate workforces, and the security of communication channels used to transmit PHI.

What is the difference between a healthcare data breach and a HIPAA data breach?

The difference between a healthcare data breach and a HIPAA data breach is that a healthcare data breach is one in which healthcare data is accessed without authorization from a healthcare provider (who may or may not be a HIPAA covered entity or business associate), while a HIPAA data breach is a breach of any Protected Health Information (which can include financial information) from any covered health plan, health care clearinghouse, or healthcare provider, or any business associate providing a service for or on behalf of a covered entity.

Therefore, not only is it the nature of the data that distinguishes a healthcare data breach from a HIPAA data breach (i.e., healthcare data vs healthcare, payment, and other data with protected status), but also the status of the organization where data was accessed without authorization (i.e., covered or non-covered healthcare provider vs HIPAA covered entity or business associate). The difference may be subtle, but it can impact the breach notification requirements, the regulatory authority, and the penalty for a data breach.

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