Healthcare Compliance News

Refuah Health Center Pays $450K HIPAA Fine; Agrees to $1.2 Million Cybersecurity Investment

New York Attorney General Letitia James has announced that an agreement has been reached with Refuah Health Center Inc. to resolve allegations it failed to maintain reasonable and appropriate cybersecurity controls to protect and limit access to sensitive patient data stored on its network. Under the terms of the agreement, Refuah Health Center has agreed to invest $1.2 million in cybersecurity and will pay $450,000 in penalties and costs.

The NY AG launched an investigation of Refuah Health Center after being notified about a May 2021 ransomware attack that compromised the personal and protected health information of 260,740 individuals, including 175,077 New Yorkers.  The Lorenz ransomware group gained access to internal systems in late May 2021, initially compromising a system that was used for viewing videos from internal cameras monitoring its facilities. That system was only protected with a four-digit code.

The attackers stole administrator credentials that were used by a former IT vendor to remotely access the network. The credentials had not been changed for 11 years and had not been deleted or disabled, even though they had not been used by the IT vendor in 7 years. The account did not have multifactor authentication enabled. The credentials allowed access to a large number of files containing patient information that had not been encrypted at the file level.

The Lorenz group exfiltrated data and encrypted files with ransomware. They contacted Refuah and issued a ransom demand and provided proof of data theft, including a list of files that were copied and a screenshot of patient data consistent with a database associated with Refuah’s dental practice. The third-party forensic investigation concentrated on the files that were stored on the shared network space but Refuah did not investigate to determine whether the database had been accessed, even though the attackers provided a screenshot of that database that displayed the records of 34 patients.

Refuah completed its analysis of the files on March 2, 2022, then mailed notification letters on April 29, 2022. The data compromised in the attack included patient names, addresses, phone numbers, Social Security numbers, driver’s license numbers, state identification numbers, dates of birth, bank account information, credit/debit card information, medical treatment/diagnosis information, Medicare/Medicaid numbers, medical record numbers, patient account numbers, and health insurance policy numbers.

Multiple HIPAA Security Rule Failures Identified

The NY AG looked at the administrative and technical safeguards that had been implemented and identified widespread noncompliance with the HIPAA Security Rule. Refuah Health Center had not conducted a risk analysis to identify risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information since March 2017 in violation of 45 C.F.R § 164.308(a)(1)(ii)(A) and (B) and had not addressed vulnerabilities that were identified in that risk analysis in the four years since it was conducted, in violation of § 164.306(a).

There were insufficient policies and procedures to prevent, detect, contain, and correct security violations, in violation of § 164.308(a)(1)(i), a lack of policies and procedures authorizing access to ePHI in violation of § 164.308(a)(4)(i), and no procedures for regularly reviewing logs of information system activity, in violation of § 164.308(a)(1)(ii)(D).

Policies and procedures for granting right of access based on access authorization policies were not present, in violation of § 164.308(a)(4)(ii)(B) and (C), there were no procedures for monitoring log-in attempts and reporting discrepancies nor procedures for creating, changing, and safeguarding passwords, in violation of § 164.308(a)(5)(ii)(C) and (D), and insufficient policies and procedures to address security incidents, and identifying and responding to suspected or known security incidents, in violation of § 164.308(a)(6)(i) and (ii).

Further, there were insufficient periodic technical and nontechnical evaluations of security policies and procedures (§ 164.308(a)(8)), insufficient technical policies and procedures for systems that maintain ePHI to allow access to persons granted access rights and no mechanism to encrypt ePHI (§ 164.312(a)(1) and (2)(iv)), insufficient controls for recording and examining activity in systems that contain or use ePHI (§ 164.312(b)), and insufficient verification of persons seeking access to ePHI to ensure they are who they claim to be (§ 164.312(d)).

The NY AG also determined there had been two violations of New York General Business Law, which requires the implementation and maintenance of reasonable safeguards to protect consumer information (§ 899-bb), and the  disclosure of a data breach in the most expedient time possible and without unreasonable delay (§ 899-aa). The later was also determined to be a violation of the HIPAA Breach Notification Rule (§ 164.404).

The agreement with the NY AG includes the requirement to invest $1.2 million in cybersecurity and make substantial improvements to its information security program, data retention policies, and incident response policies and procedures. Refuah is also required to issue notifications to all individuals whose data was compromised within 90 days.

“New Yorkers should receive medical care and trust that their personal and health information is safe,” said Attorney General James. “This agreement will ensure that Refuah is taking the appropriate steps to protect patient data while also providing affordable health care. Strong data security is critically necessary in today’s digital age and my office will continue to protect New Yorkers’ data from companies with inadequate cybersecurity.”

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FTC Prohibits Rite Aid from Using Facial Technology System for Surveillance for 5 Years

Rite Aid has been banned from using facial recognition technology for security surveillance for five years as part of a settlement with the Federal Trade Commission (FTC), which determined the pharmacy chain failed to mitigate potential risks to consumers from misidentification.

Between 2012 and 2020, Rite Aid used artificial intelligence-based facial recognition technology in hundreds of its stores to identify customers who may have been engaged in shoplifting or other problematic behaviors. While the system correctly identified many individuals who had engaged in these behaviors, the system also recorded thousands of false positives, where the facial recognition technology incorrectly matched individuals with others who had previously been identified as shoplifters or had engaged in other problematic behaviors. The misidentified individuals were then erroneously accused of wrongdoing by Rite Aid employees.

The FTC found that the facial recognition technology was more likely to record false positives in communities that were predominantly Black or Asian, compared to plurality-White communities, indicating bias in the technology and heightened risks to certain consumers because of race or gender. According to the FTC, Rite Aid contracted with two technology firms to build a database of images and videos of “persons of interest,” who were thought to have engaged in shoplifting or other problematic behaviors in Rite Aid stores, and that database was used for the AI-based facial recognition system. Tens of thousands of images and videos were collected along with names and background information, including background criminal data. Many of the images in the database were of low quality and had been collected from store security cameras, the mobile devices of employees, and in some cases, from news stories. “The technology sometimes matched customers with people who had originally been enrolled in the database based on activity thousands of miles away, or flagged the same person at dozens of different stores all across the United States”, according to the FTC.

“Rite Aid’s reckless use of facial surveillance systems left its customers facing humiliation and other harms, and its order violations put consumers’ sensitive information at risk,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection. “Today’s groundbreaking order makes clear that the Commission will be vigilant in protecting the public from unfair biometric surveillance and unfair data security practices.”

Rite Aid was alleged to have failed to consider and mitigate risks to consumers from misidentification, failed to take into account the limitations of the technology and the high risk of misidentifying Black and Asian individuals, did not properly test, assess, measure, document, or inquire about the accuracy of the technology before deployment, failed to prevent low-quality images from being fed into the system, failed to monitor or test the accuracy of the technology after deployment, and failed to adequately train employees tasked with operating the technology and flag that it could generate false positives.

The FTC also said Rite Aid violated a previous 2010 data security order with the FTC that resolved a complaint that Rite Aid failed to protect the medical privacy of customers and employees, which required Rite Aid to implement a comprehensive information security program. As an example, the FTC alleged that Rite Aid conducted many security assessments of service providers orally and did not obtain or possess backup documentation of those assessments, including those that were considered by Rite Aid to be high-risk.

Rite Aid has been ordered to delete or destroy all photos and videos of consumers used in connection with the operation of the facial recognition or analysis system within 45 days, and within 60 days, to identify all third parties that received photos or videos as part of the facial recognition and analysis and instruct them to also delete the photos and videos.

In addition to the ban on facial recognition technology, Rite Aid is prohibited from using any automated biometric security or surveillance system that is not otherwise prohibited by the order unless a comprehensive automated biometric security or surveillance system monitoring program is established and maintained to identify and address risks that could result in physical, financial, or reputational harm to consumers, stigma, or severe emotional distress.

Rite Aid must also notify consumers when their biometric information is enrolled in a database used in connection with a biometric security or surveillance system and when Rite Aid takes some kind of action against them based on an output generated by such a system, and must investigate and respond to consumer complaints about actions taken against them based on automated biometric security or surveillance system.

Rite Aid said it is pleased to have reached an agreement with the FTC which means the company can put the matter behind it; however, said, “We fundamentally disagree with the facial recognition allegations in the agency’s complaint.” Rite Aid also explained that the allegations related to a facial recognition technology pilot program that was deployed in a limited number of stores. “Rite Aid stopped using the technology in this small group of stores more than three years ago, before the FTC’s investigation regarding the Company’s use of the technology began.” All parties have agreed to the consent order but it has yet to be approved by a judge.

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Website Pixel Use Leads to $300K Fine for New York Presbyterian Hospital

New York Presbyterian Hospital has agreed to settle alleged violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule with the New York Attorney General and will pay a financial penalty of $300,000.

NYP operates 10 hospitals in New York City and the surrounding metropolitan area and serves approximately 2 million patients a year. In June 2016, NYP added tracking pixels and tags to its nyp.org website to track visitors for marketing purposes. In early June 2022, NYP was contacted by a journalist from The Markup and was informed that these tools were capable of transmitting sensitive information to the third-party providers of the tools, including information classified as protected health information under HIPAA.

On June 16, 2023, The Markup published an article about the use of these tools by NYP and other U.S. hospitals, by which time NYP had already taken steps to remove the tools from its website and had initiated a forensic investigation to determine the extent of any privacy violations.  NYP determined that PHI had potentially been impermissibly disclosed and reported the breach to the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) on March 20, 2023, as involving the protected health information (PHI) of up to 54,396 individuals.

NY Attorney General Launches HIPAA Investigation

NY Attorney General, Letitia James opened an investigation of NYP in response to the reported breach to determine whether NYP had violated HIPAA and New York laws. The investigation confirmed that NYP had added several tracking tools to its website that were provided by third parties such as Bing, Google, Meta/Facebook, iHeartMedia, TikTok, The Trade Desk, and Twitter. These tools were configured to trigger on certain user events on its website. Most were configured to send information when a webpage loaded, and some sent information in response to clicks on certain links, the transmission of forms, and searches conducted on the site. The snippets of information sent to third parties included information about the user’s interactions on the website, including the user’s IP address, URLs visited, and searches. The tools provided by Google, Meta, and the Trade Desk also received unique identifiers that had been stored in cookies on the user’s devices.

Meta/Facebook also received information such as first and last name, email address, mailing address, and gender information, if that information was entered on a webpage where the Meta pixel was present. In some cases, the information sent to third parties included health information, such as if the user researched health information, performed a search for a specialist doctor, or scheduled an appointment. Certain URLs also revealed information about a specific health condition.

The tracking tools from Meta, Google, and the Trade Desk were used to serve previous website visitors with targeted advertisements based on their previous interactions on the website. NYP and its digital marketing vendor also used Meta pixel data to categorize website visitors based on the pages they visited and used Meta pixel to serve advertisements to other individuals with similar characteristics, known as “lookalike audiences.” For example, NYP identified individuals who visited webpages related to prostate cancer, and those individuals were then served targeted advertisements on other third-party websites related to prostate cancer.

Commonly Used Website Tracking Tools Violate HIPAA

These tracking tools are widely used by businesses of all types and sizes for marketing, advertising, and data collection purposes; however, in contrast to most businesses with an online presence, hospitals are HIPAA-covered entities and are required by federal law to ensure the privacy of personal and health information. As confirmed by the HHS’ Office for Civil Rights in December 2022 guidance, third-party tools that are capable of collecting and transmitting PHI may only be used if there is a business associate agreement (BAA) in place and the disclosure of PHI is permitted by HIPAA or if HIPAA-compliant authorizations have been obtained from patients. NYP, like many other HIPAA-covered entities that used these tools, had no BAAs in place with the tracking tool vendors and did not obtain consent from patients to disclose their PHI to those vendors.

The New York Attorney General determined that while NYP had policies and procedures relating to HIPAA compliance and patient privacy, they did not include appropriate policies and procedures for vetting third-party tracking tools. The New York Attorney General determined that the use of these tools violated § 164.502(a) of the HIPAA Privacy Rule, which prohibits disclosure of PHI, and § 164.530(c) and (i), which requires administrative, technical, and physical safeguards to protect the privacy of PHI and policies and procedures to comply with those requirements. NYP was also found to have violated New York Executive Law § 63 (12), by misrepresenting the manner and extent to which it protects the privacy, security, and confidentiality of PHI.

Settlement Agreed to Resolve Alleged Violations of HIPAA and State Laws

NYP fully cooperated with the investigation and chose to settle the alleged violations with no admission or denial of the findings of the investigation. In addition to the financial penalty, NYP has agreed to comply with Executive Law § 63 (12), General Business Law § 899-aa, and the HIPAA Privacy Rule Part 164 Subparts E and the HIPAA Breach Notification Rule 45 C.F.R. Part 164 Subpart D concerning the collection, use, and maintenance of PHI. NYP is also required to contact all third parties that have been sent PHI and request that information be deleted and NYP has agreed to conduct regular audits, reviews, and tests of third-party tools before deploying them to an NYP website or app, and conduct regular reviews of the contracts, privacy policies, and terms of use associated with third-party tools.

NYP is also required to clearly disclose on all websites, mobile applications, and other online services it owns or operates, all third parties that receive PHI as the result of a pixel, tag, or other online tool, and provide a clear description of the PHI that is received.  The notice must be placed on all unauthenticated web pages that allow individuals to search for doctors or schedule appointments, as well as any webpage that addresses specific symptoms or health conditions.

OCR’s guidance on tracking technologies is being challenged in court due to doubts about whether the types of information collected by tracking tools fall under the HIPAA definition of PHI. The requirements of the settlement concerning the use of tracking technologies and the restrictions imposed will remain in effect until the relevant sections of OCR’s guidance are amended, superseded, withdrawn, revoked, supplanted by successive guidance, or temporarily or permanently enjoined and/or rejected by a court ruling applicable to HIPAA-covered entities in New York.

“New Yorkers searching for a doctor or medical help should be able to do so without their private information being compromised,” said Attorney General James. “Hospitals and medical facilities must uphold a high standard for protecting their patients’ personal information and health data. New York-Presbyterian failed to handle its patients’ health information with care, and as a result, tech companies gained access to people’s data. Today’s agreement will ensure that New York-Presbyterian is not negligent in protecting its patients’ information.”

A spokesperson for NYP responded to the resolution of the investigation and provided the following statement, “We are pleased to have reached a resolution with the New York State Attorney General on this matter. The privacy and security of our patients’ health information is of paramount importance, and the protection of this confidential information remains a top priority. We continually assess our data collection, data privacy, and digital monitoring tools and practices so that they meet or exceed the highest standards.”

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Compliancy Group Best Healthcare Compliance Software According to G2

Compliancy Group has been named the best healthcare compliance software provider by G2 in its Winter 2023 Reports. G2, (formerly G2 Crowd) is the world’s largest and most trusted software marketplace. Each year, 80 million people visit the G2 peer-to-peer business software review website to read and write reviews of software and conduct research to inform purchase decisions. Each quarter, G2 releases Grid Reports to help technology buyers visualize the marketplace and identify companies that provide software solutions to meet their needs. The Grid Reports categorize companies as niche providers, contenders, high performers, and leaders based on their market presence and customer satisfaction scores. Leaders are companies that combine a strong market presence with high customer satisfaction scores.

In the Winter 2023 Reports, Compliance Group was named the best software company in the healthcare compliance software category. To qualify for inclusion in the healthcare compliance software category, a company must provide software that allows users to monitor, track, and update any changes to industry and/or governmental regulation and practice; facilitate the designation of compliance officers and committees; develop compliance-specific policies and procedures, including standards of conduct; facilitate open lines of communication; support appropriate and relevant compliance training and education; set up, track, and respond to detected compliance offenses; and support or offer internal monitoring, auditing, and measuring efforts.

98% of users of Compliancy Group’s Healthcare compliance software gave a 4- or 5-star rating and 96% of users believed the company to be heading in the right direction. 96% said that they would be likely to recommend the software. The company was recognized by G2 as being the easiest to do business with, a leader in the Americas, having the highest user adoption rate, and was also named as a momentum leader – a company that combines high satisfaction scores, with a strong digital presence, and strong employee growth.

Compliancy Group was also named a leader in the healthcare risk management category. To be included in the healthcare risk management software category, a company must support the creation and modification of healthcare risk management plans; provide risk surveillance tools; collect patient, provider, and operational data across the hospital; and comply with healthcare regulations such as HIPAA and HITECH. In this category, Compliancy Group achieved an average customer satisfaction score of 4.8 out of 5 and was ranked as the 2nd easiest healthcare risk management software to use.

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Optum Medical Care of New Jersey Settles OCR HIPAA Right of Access Investigation

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has agreed to settle alleged violations of the HIPAA Privacy Rule with Optum Medical Care of New Jersey for $160,000.

Optum Medical Care of New Jersey, formerly known as Riverside Medical Group and Riverside Pediatric Group, is a private multi-specialty physician group with approximately 150 locations in New Jersey and Southern Connecticut. In the Fall of 2021, OCR received six complaints from individuals who had not been provided with their records after sending a request to Optum Medical Care. The requests were to obtain a copy of an individual’s own records or requests from parents for copies of their minor children’s records.

The HIPAA Privacy Rule gives individuals the right to obtain a copy of their medical records and those of their minor children. When a request is received by a HIPAA covered entity, the records must be provided within 30 calendar days, although under certain limited circumstances, a 30-day extension is possible.

OCR launched an investigation in February 2022 in response to the complaints and determined that Optum Medical Care had exceeded the allowed timeframe for providing those records. The complainants had to wait between 84 days and 231 days to receive their requested records.

Optum Medical Care chose to settle the alleged violations and agreed to pay a $160,000 financial penalty and adopt a corrective action plan (CAP) that includes reviewing and revising its policies and procedures for individual access to PHI, providing training to the workforce on those new procedures, and ensuring that all patients are provided with their requested records within 30 days. In the event of a right of access request being denied, OCR must be informed and provided with documentation to support that denial. OCR will monitor Optum Medical Care for compliance with the CAP for a period of one year.

OCR launched its HIPAA Right of Access enforcement initiative in the fall of 2019, and this is the 46th investigation to result in a financial penalty. “Healthcare providers must make responding to parents’ or patients’ request for access to their medical records in a timely manner a priority,” said OCR Director Melanie Fontes Rainer. “Access to medical records is a fundamental right under HIPAA, and one for which OCR receives thousands of complaints each year.  This is the law—providers must proactively respond to record requests and ensure timely access.  Access to medical records empowers patients and their families to make decisions about their health care and improve their health overall. It is critical that providers follow the law.”

This is the 13th HIPAA enforcement action of 2023 to result in a financial penalty. In 2023, OCR has imposed $4,176,500 in financial penalties. The average penalty was $321,269 and the median penalty was $100,000.

OCR has also stated in its Healthcare Sector Cybersecurity Strategy that it is working with Congress to increase the penalties for HIPAA violations.

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