HIPAA Compliance News

Kaiser Pays $49 Million to Settle Improper Disposal Investigation

California Attorney General Rob Bonta has announced a $49 million settlement has been reached with Kaiser Foundation Health Plan Foundation Inc. and Kaiser Foundation Hospitals to resolve allegations of improper disposal of hazardous waste, medical waste, and protected health information.

Oakland, CA-based Kaiser is the largest healthcare provider in California with more than 700 healthcare facilities in the state, serving more than 8.8 million patients. An investigation was launched by 6 district attorneys from Alameda, San Bernardino, San Francisco, San Joaquin, San Mateo, and Yolo counties into the unlawful dumping of dangerous items.  Undercover staff from the district attorneys’ offices inspected dumpsters at 16 different Kaiser facilities. The dumpsters were not secured and the contents were destined for disposal in landfill sites.

The inspectors found hundreds of items of hazardous and medical waste, including aerosols, cleansers, sanitizers, batteries, syringes, medical tubing containing body fluids, pharmaceuticals, and electronic wastes. The dumpsters also contained more than 10,000 paper records that contained the protected health information of 7,700 patients. The California Department of Justice later joined the investigation and expanded it statewide at other Kaiser facilities. Kaiser was alleged to have violated the Health Insurance Portability and Accountability Act (HIPAA), and California’s Hazardous Waste Control Law, Medical Waste Management Act, Confidentiality of Medical Information Act, Customer Records Law, and Unfair Competition Law.

In response to the investigation, Kaiser engaged a third-party consultant to conduct more than 1,100 trash audits at its facilities and its operating procedures have been updated to ensure proper waste disposal across its facilities in California. The settlement consists of $37,513,000 in civil penalties, $4,832,000 in attorneys’ fees and costs, and $4,905,000 for supplemental environmental projects. A further $1.75 million in civil monetary penalties must be paid if Kaiser has not invested a further $3.5 million in its Californian facilities to provide enhanced environmental compliance measures.

Kaiser is also required to retain an independent third-party auditor to conduct more than 520 trash compactor audits at its California facilities to make sure hazardous items and protected health information are not being disposed of in regular trash, and at least 40 programmatic field audits must be conducted each year for the next 5 years to evaluate compliance with its policies covering hazardous waste, medical waste, and protected health information.

“The illegal disposal of hazardous and medical waste puts the environment, workers, and the public at risk. It also violates numerous federal and state laws,” said Attorney General Bonta. “As a healthcare provider, Kaiser should know that it has specific legal obligations to properly dispose of medical waste and safeguard patients’ medical information. I am pleased that Kaiser has been cooperative with my office and the district attorneys’ offices, and that it took immediate action to address the alleged violations.”

The post Kaiser Pays $49 Million to Settle Improper Disposal Investigation appeared first on HIPAA Journal.

OCR, FTC Publish Online Tracking Technology Warning Letters

The Department of Health and Human Services’ Office for Civil Rights (OCR) and the Federal Trade Commission (FTC) have published the letters that were sent to hospital systems and telehealth providers in July 2023 advising them about the privacy risks associated with website tracking technologies such as Meta Pixel and Google Analytics.

The widespread use of these tools on hospital websites and the risk of impermissible disclosures of protected health information (PHI) prompted OCR to issue guidance for HIPAA-regulated entities in December 2022. OCR stated in the guidance that these tools are not permitted under HIPAA unless consent is obtained via HIPAA authorizations or if there is a valid business associate relationship with the technology provider and a corresponding HIPAA-compliant business associate agreement (BAA). The FTC has also taken an interest in these tools and has taken action against non-HIPAA-regulated entities for alleged violations of the FTC Act and the FTC’s Health Breach Notification Rule with respect to tracking technologies.

The July 2023 letters explain that serious privacy and security risks have been identified with online tracking technologies and the recipients of the letters were warned that their websites and mobile applications may have these tracking tools in place that could be disclosing consumers’ sensitive personal health information to third parties. The types of information disclosed would depend on where the tracking technologies have been added. If they have been added to appointment scheduling apps or behind the logins of patient portals they could disclose highly sensitive information to third parties such as health conditions, diagnoses, medications, treatment information, treatment locations, frequency of visits, and more, along with identifiers that link that information to individuals. The disclosed information could be used by third parties for advertising purposes and could potentially result in identity theft, financial loss, discrimination, stigma, mental anguish, or other serious negative consequences to the reputation, health, or physical safety of the individual or to others.

The recipients of the letters, which include a diverse range of HIPAA-regulated entities and non-HIPAA-covered entities that collect health information, have been advised to review OCR and FTC guidance, assess the extent to which tracking technologies are in use, and ensure they are fully protecting the privacy and security of individuals’ health information.

The recipients of the letters have now been made public in the 387-page PDF document jointly published by OCR and FTC on their websites. While OCR and the FTC had reason to issue the letters to these organizations, receipt of a letter does not mean that tracking technologies are currently being used or HIPAA, the FTC Act, or the Health Breach Notification Rule have been violated. The recipients of the letters are listed below.

ADHD Online, MI DearBrightly, CA Kick Health, WA Peace Health, WA Strut Health, TX
Advocate Aurora Health, WI Done, CA KwikMed, AZ Penn Medicine Chester County Hospital, PA Talkiatry, NY
Alfie, NY Dorsal, NY LCMC Health System, LA Penn Medicine, PA Talkspace, NY
Alpha, CA Duke University Health System, NC Lemonaid, CA Picnic, NY Tampa General Hospital, FL
Apostrophe, CA El Camino Hospital, CA Loyola Medicine, IL Piedmont Healthcare, GA Texas Health Resources, TX
Array Behavioral Care, NJ Eleanor Health, MA Mantra Health, NY Plume, CO The Wellness Company, RI
Ascension, MO Elektra Health, NY Marshall Medical Center, CA PRJKT RUBY, AZ Thomas Jefferson Hospital, PA
Barnes-Jewish Hospital, MO Everlywell, TX MedStar Health, MD Push Health, CA Tufts Medical Center, MA
Barton Healthcare System, CA Facet, NY Memorial Healthcare System, FL QCare Plus, FL UC Davis Health, CA
Beaumont Health System, MI Favor, CA MemorialCare Long Beach Medical Center, CA Quick MD, CA UCLA Reagan Medical Center, CA
Bellin Health, WI Folx, MA Mercy Medical Center, MD Relief Labs, Inc. d/b/a Clearing, NY UCSF Office of Legal Affairs, CA
Bicycle Health, MA Found, CA Middlesex Health, CT Remedy Psychiatry, CA UnityPoint Health, IA
Bon Secours Mercy Health, OH Froedtert Hospital and the Medical College of Wisconsin, WI Mindbloom, FL Renown Health, NV University Hospitals Cleveland Medical Center, OH
Boulder Care, OR Gennev, WA Minded, NY Riverside Health System, VA University of Chicago Medicine, IL
Brigham and Women’s Faulkner Hospital, MA Grady Health System, GA Mistr, FL Rochester Regional Health, NY University of Iowa Hospitals and Clinics, IA
Brightline, CA Henry Ford Hospital, MI MultiCare Health System, WA Roman, NY University of Kansas Health System, KS
Brightside, CA Hers, CA Musely, CA Rush University Medical Center, IL University of Pittsburgh Medical Center, PA
Calibrate, NY Hims, CA My Ketamine Home, FL Salem Health, OR University of Texas Southwestern Medical Center, TX
CallonDoc, TX Hone Health, NY Nemours Children’s Health, FL Sanford USD Medical Center, SD University of Vermont Health Network, VT
Cedars-Sinai Medical Center, CA Honor Health, AZ New York Presbyterian Hospital, NY Sarasota Memorial Health Care System, FL Wexner Medical Center, OH
Chesapeake Regional Healthcare, VA Houston Methodist, TX Northwestern Medicine Central DuPage Hospital, IL Scripps Memorial Hospital La Jolla – Scripps Health, CA Willis-Knighton Health System, LA
Children’s Wisconsin, WI Inova Health System, VA Northwestern Memorial Healthcare, IL Sharp Healthcare, CA Wisp, CA
Cone Health, NC Invigor Medical, WA Nue Life, FL Sparrow Health Systems, MI Wondermed, CA
Cove, NY Johns Hopkins Hospital, MD Nurx, CA St. Joseph Mercy Health System, MI Workit, FL
Covenant Health, TN K Health, NY Oar, NY St. Luke’s Health System, ID Yale New Haven Health, CT
Curology, CA Keeps, NY Ophelia, NY St. Tammany Health System, LA

The post OCR, FTC Publish Online Tracking Technology Warning Letters appeared first on HIPAA Journal.

Judge Questions Whether Website Metadata is Regulated by HIPAA

The HHS’ Office for Civil Rights released guidance in 2022 on HIPAA and website tracking technologies and confirmed disclosures of protected health information to third parties via website tracking technologies is a HIPAA violation unless authorization has been received from patients or if there is a valid business associate agreement in place. OCR and the Federal Trade Commission also wrote to 130 healthcare and telehealth providers to warn them about tracking technologies on their websites and OCR has made HIPAA violations related to website tracking tools an enforcement priority.

However, OCR’s interpretation that metadata is regulated under the Health Insurance Portability and Accountability Act has been questioned by an Illinois court in a ruling on a class action lawsuit that was filed against a healthcare provider over the disclosure of patient data via website tracking technologies.

The lawsuit – Marguerite Kurowski and Brenda McClendon v. Rush System for Health d/b/a Rush University System for Health – was filed in District Court for the Northern District of Illinois, Eastern Division and alleged that third-party tracking code had been placed on the defendant’s website and MyChart patient portal which resulted in the plaintiffs’ individually identifiable health information (IIHI) being disclosed to Facebook, Google, and Bidtellect for advertising purposes.

The lawsuit was initially dismissed for the failure to state a claim aside from the request for injunctive relief, then an amended complaint was filed that asserted the same 5 claims plus a further 6. The lawsuit alleged violations of the federal Wiretap Act as amended by the Electronic Communications Privacy Act of 1986, breach of an implied duty of confidentiality, violations of the Illinois Consumer Fraud and Deceptive Business Practices Act, violations of the Illinois Uniform Deceptive Trade Practices Act, intrusion upon seclusion, publication of private facts, trespass to chattels, breach of contract, breach of the duty of good faith and fair dealing, unjust enrichment, and violations of the Illinois Eavesdropping Act.

Rush moved to have the amended lawsuit dismissed and the court granted the motion for all counts aside from the breach of contract and Illinois Eavesdropping Act claims. The lawsuit claimed that per OCR guidance, the disclosure of IIHI to Meta, Google, and Bidtellect was a HIPAA violation; however, in the ruling dismissing the wiretapping claim, the court rejected using the HHS bulletin as a basis for assessing liability under federal wiretapping laws and also questioned whether website metadata actually qualified as IIHI.

“The interpretation of IIHI offered by HHS in its guidance goes well beyond the meaning of what the statute can bear. As just described, IIHI under section 1320d(6) must, in addition to other requirements, “relate to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual,” wrote District Judge, Matthew F. Kennelly. “The type of metadata that Kurowski alleges was transmitted via third-party source code does not in the least bit fit into that category.”

While it is possible that information disclosed in private communications between the plaintiff and the defendant via the website may have been transmitted to third parties and the transmitted information may qualify as IIHI, the plaintiff contended that it was unreasonable to expect her to disclose that type of intimate information she transmitted to the defendant in her complaint. “Kurowski could have requested to file the complaint under seal,” wrote Kennelly. “Kurowski cannot reasonably expect to bring a lawsuit related to the invasion of her medical privacy and completely evade revealing what it is that she alleges Rush disclosed to third parties.”

The post Judge Questions Whether Website Metadata is Regulated by HIPAA appeared first on HIPAA Journal.

Joint Commission Issues Guidance on Ensuring Patient Safety After a Cyberattack

The Joint Commission has issued a Sentinel Event Alert offering guidance on preserving patient safety following a cyberattack. Healthcare cyberattacks have been increasing in number and sophistication and it is no longer a case of if a healthcare organization will be attacked but when.

Cyberattacks can cause considerable disruption to healthcare operations and put patient care at risk so it is critical that healthcare organizations do all they can to prevent cyberattacks, such as decreasing the attack surface, updating software and patching promptly, providing phishing awareness training, and implementing a range of cybersecurity solutions. Healthcare organizations must also plan for the worst case scenario and must assume that their defenses will be breached. They must therefore have a tried and tested incident response plan that can be activated immediately in the event of a cyberattack.

When defenses are breached and unauthorized individuals have established a foothold in internal networks, a great deal of the recovery process will be handled by the IT department; however, all hospital staff members must be prepared to operate during such an emergency and must be included in the incident response planning process. A good starting point is the hazards vulnerability analysis (HVA), which is required by the Joint Commission. The HVA must cover human-related hazards, which include cyberattacks. The HVA helps hospitals identify and implement mitigation and preparedness actions to reduce the disruption of services and functions and ensure patient safety in the event of an attack. The Joint Commission also requires a continuity of operations plan, disaster recovery plan, emergency management education and training program, and these must be evaluated annually.

The Sentinel Event Alert provides recommendations on these processes specific to cyberattacks:

  • Evaluate HVA findings and prioritize hospital services that must remain operational and safe during extended downtime.
  • Form a downtime planning committee to develop preparedness actions and mitigations. The planning committee should include representation from all stakeholders.
  • Develop downtime plans, procedures, and resources and ensure they are regularly updated.
  • Designate response teams – An interdisciplinary team should be created that can be mobilized following a cyberattack.
  • Train team leaders, teams, and all staff on operating procedures during downtimes. Develop drills and exercises to ensure staff members are familiar with downtime resources.
  • Establish situational awareness with effective communication throughout the organization and with patients and families.
  • Following a cyberattack, regroup, evaluate, and make necessary improvements to the incident response plan and improve protections for systems to address the specific failures that allowed the attack to succeed.

“Cyberattacks cause a variety of care disruptions – leading to patient harm and severe financial repercussions,” said David W. Baker, MD, MPH, FACP, the Joint Commission’s executive vice president for healthcare quality evaluation and improvement. “Taking action now can help prepare healthcare organizations to deliver safe patient care in the event of future cyberattacks. The recommendations in the Sentinel Event Alert, as well as The Joint Commission’s related requirements on establishing and following a continuity of operations plan, disaster recovery plan and more, can help healthcare organizations successfully respond to a cyber emergency.”

The post Joint Commission Issues Guidance on Ensuring Patient Safety After a Cyberattack appeared first on HIPAA Journal.

July 2023 Healthcare Data Breach Report

There was a 15.2% fall in reported data breaches in July with 56 breaches of 500 or more records reported to the HHS’ Office for Civil Rights (OCR), which makes July an average month for data breaches. Over the past 12 months, 57 breaches have been reported each month on average; however, July was not an average month in terms of the number of compromised records.

There was a 261% month-over-month increase in breached records in July, with 18,116,982 records breached across the 56 reported incidents. The incredibly high total was due to a major data breach at HCA Healthcare that saw the records of 11,270,000 individuals compromised.

The figures this month bring the running breach total for 2023 up to 395 incidents, across which the records of 59,569,604 individuals have been exposed or stolen. The average breach size for 2023 is 150,809 records and the median breach size is 4,209 records. Over the past 12 months, more than 81.76 million records have been breached across 683 incidents.

Largest Healthcare Data Breaches Reported in July

HCA Healthcare is a Nashville, TN-based health system that operates 182 hospitals and around 2,300 sites of care. Hackers gained access to an external electronic storage facility that was used by a business associate for automating the formatting of email messages, such as reminders sent to patients about scheduling appointments. While the breach was one of the largest ever reported, the data stolen in the attack was limited. HCA Healthcare said the data compromised was limited to name, city, state, zip code, email, telephone number, date of birth, gender, service date, location, and, in some instances, the date of the next appointment.

The second largest breach, reported by the Centers for Medicare and Medicaid Services (CMS) as affecting 1,362,470 Medicare recipients, was more severe due to the types of data compromised. The breach occurred at a CMS contractor, Maximus Federal Services, Inc. (Maximus). Maximus was one of hundreds of organizations to fall victim to the mass exploitation of a zero-day vulnerability in Progress Software’s MOVEit Transfer file transfer solution. Progress Software identified the vulnerability and issued a patch on May 31, 2023; however, the vulnerability had already been exploited by the Clop hacking group. The total number of victims of this breach has yet to be determined; however, Kon Briefing has been tracking the breach reports and reports that at least 734 organizations had the vulnerability exploited and between 42.7 million and 47.6 million records were stolen in the attack. Clop did not encrypt data, just stole files and issued ransom demands, payment of which was required to prevent the release or sale of the stolen data. In July, 26 breaches of 10,000 or more records were reported to OCR, 11 of which were due to the exploitation of the MOVEit vulnerability. All but two of the 26 breaches were due to hacking incidents.

Name of Covered Entity State Covered Entity Type Individuals Affected Type of Breach Cause of Breach
HCA Healthcare TN Business Associate 11,270,000 Hacking/IT Incident Hacking Incident – External, electronic storage facility used by a business associate
Centers for Medicare & Medicaid Services MD Health Plan 1,362,470 Hacking/IT Incident Hacking incident – MOVEit Transfer data theft/extortion (Maximus)
Florida Health Sciences Center, Inc. dba Tampa General Hospital FL Healthcare Provider 1,313,636 Hacking/IT Incident Hacking incident – Ransomware attack
Pension Benefit Information, LLC MN Business Associate 1,209,825 Hacking/IT Incident Hacking incident – MOVEit Transfer data theft/extortion
Allegheny County PA Healthcare Provider 689,686 Hacking/IT Incident Hacking incident – MOVEit Transfer data theft/extortion
United Healthcare Services, Inc. Single Affiliated Covered Entity CT Health Plan 398,319 Hacking/IT Incident Hacking incident
Johns Hopkins Medicine MD Healthcare Provider 310,405 Hacking/IT Incident Hacking incident – MOVEit Transfer data theft/extortion
Harris County Hospital District d/b/a Harris Health System TX Healthcare Provider 224,703 Hacking/IT Incident Hacking incident – MOVEit Transfer data theft/extortion
Precision Anesthesia Billing LLC FL Business Associate 209,200 Hacking/IT Incident Hacking incident – Ransomware attack
Fairfax Oral and Maxillofacial Surgery VA Healthcare Provider 208,194 Hacking/IT Incident Hacking incident
The Chattanooga Heart Institute TN Healthcare Provider 170,450 Hacking/IT Incident Hacking incident – Data theft confirmed
Phoenician Medical Center, Inc AZ Healthcare Provider 162,500 Hacking/IT Incident Hacking incident – Data theft confirmed
UT Southwestern Medical Center TX Healthcare Provider 98,437 Hacking/IT Incident Hacking incident – MOVEit Transfer data theft/extortion
Hillsborough County, Florida (County Government) FL Healthcare Provider 70,636 Hacking/IT Incident Hacking incident – MOVEit Transfer data theft/extortion
Family Vision of Anderson, P.A. SC Healthcare Provider 62,631 Hacking/IT Incident Hacking incident – Ransomware attack
Jefferson County Health Center IA Healthcare Provider 53,827 Hacking/IT Incident Hacking incident – Data theft confirmed (Karakurt threat group)
New England Life Care, Inc. ME Healthcare Provider 51,854 Hacking/IT Incident Hacking incident
Care N’ Care Insurance Company, Inc. TX Health Plan 33,032 Hacking/IT Incident Hacking incident – MOVEit Transfer data theft/extortion (TMG Health Inc)
Synergy Healthcare Services GA Business Associate 25,772 Hacking/IT Incident Hacking incident
Rite Aid Corporation PA Healthcare Provider 24,400 Hacking/IT Incident Hacking incident – MOVEit Transfer data theft/extortion
Life Management Center of Northwest Florida, Inc. FL Healthcare Provider 19,107 Hacking/IT Incident Hacking incident
Saint Francis Health System OK Healthcare Provider 18,911 Hacking/IT Incident Hacking incident – MOVEit Transfer data theft/extortion
Pennsylvania Department of Human Services PA Healthcare Provider 16,390 Unauthorized Access/Disclosure Hacking incident – Unauthorized access to a system test website
The Vitality Group, LLC IL Business Associate 15,569 Hacking/IT Incident Hacking incident – MOVEit Transfer data theft/extortion
Wake Family Eye Care NC Healthcare Provider 14,264 Hacking/IT Incident Hacking incident – Ransomware attack
East Houston Med and Ped Clinic TX Healthcare Provider 10,000 Unauthorized Access/Disclosure Storage unit sold that contained boxes of patient records

Causes of July 2023 Data Breaches

Hacking incidents dominated the breach reports in July, with 49 incidents reported to OCR involving 18,083,328 records. The average breach size was 369,048 records and the median breach size was 9,383 records. The majority of these incidents were data theft and extortion incidents, where hackers gained access to networks, stole data, and issued ransom demands. Many hacking groups are now choosing not to encrypt files and are concentrating on data theft and extortion. When claiming responsibility for the MOVEit attacks, a spokesperson for the Clop group said they could have encrypted data but chose not to.

There were 7 unauthorized access/disclosure incidents reported involving the PHI of 33,654 individuals. The average breach size was 4,808 records and the median breach size was 1,541 records. Three of those incidents involved unauthorized access to paper records and three were email-related data breaches. There were no reported breaches involving the loss, theft, or impermissible disclosure of physical records or devices containing electronic PHI.

Where did the Data Breaches Occur?

The OCR breach portal lists data breaches by the reporting entity, although that is not necessarily where the data breach occurred. Business associates of HIPAA-covered entities may report their own breaches, they may be reported by the covered entity, or a combination of the two. For instance, Maximus reported its MOVEit Transfer breach as affecting 932 individuals, but many of its clients were affected and the total number of individuals affected was in the millions.

The raw data on the breach portal indicates 37 breaches at healthcare providers, 11 breaches at business associates, 7 at health plans, and one breach at a healthcare clearing house. The charts below are based on where the breach occurred, rather than the reporting entity.

Geographical Distribution of Data Breaches

Data breaches of 500 or more records were reported by HIPAA-regulated entities in 25 states. Texas was the worst affected state with 7 breaches, with Florida and California also badly affected.

State Breaches
Texas 7
Florida 6
California 5
Maryland, Pennsylvania & Tennessee 4
Arizona & North Carolina 3
Connecticut, Illinois & Minnesota 2
Georgia, Idaho, Indiana, Iowa, Kentucky, Maine, Michigan, New Jersey, New York, Ohio, Oklahoma, South Carolina, Virginia & Washington 1

HIPAA Enforcement Activity in July 2023

There were no enforcement actions announced by OCR or state attorneys general in July to resolve HIPAA violations.

The post July 2023 Healthcare Data Breach Report appeared first on HIPAA Journal.

OCR’s COVID-19 Telehealth Enforcement Discretion Transition Period Ends

At 11.59 pm on August 9, 2023, the transition period for ensuring telehealth services are fully HIPAA-compliant came to an end. Healthcare providers must now ensure that their telehealth services are provided using platforms that are fully compliant with the HIPAA Rules.

The enforcement discretion policy was initiated for telehealth in response to the COVID-19 pandemic. OCR announced that it would not impose sanctions and penalties for HIPAA violations in connection with the good faith provision of telehealth services, provided non-public facing remote communications technologies were used for providing telehealth services. That meant that communications platforms that would not normally be permitted under HIPAA could be used for providing telehealth services, such as platforms provided by vendors who would not sign business associate agreements covering their products.

The enforcement discretion period was in effect for the duration of the COVID-19 Public Health Emergency (PHE); however, when the PHE came to an end, OCR announced there would be a 90-day transition period to give healthcare providers time to ensure their communication tools were made HIPAA-compliant or transition to an alternative communications tool that is fully compliant with the HIPAA Rules. Now that the enforcement discretion period and the transition period are over, healthcare providers must only use fully compliant communications tools for providing telehealth services or risk financial penalties.

OCR has published guidance to help healthcare providers provide audio-only telehealth services and ensure compliance with the HIPAA Rules. The guidance includes answers to commonly asked questions with respect to HIPAA and telehealth and can be viewed on the HHS website.

The post OCR’s COVID-19 Telehealth Enforcement Discretion Transition Period Ends appeared first on HIPAA Journal.

AHA, AMA, BCBSA Urge CMS Not to Adopt Proposed Standards for Healthcare Attachments

The HHS’ Centers for Medicare and Medicaid Services (CMS) is being urged not to implement the proposed standards for prior authorization attachments, as detailed in its December 2022 Notice of Proposed Rulemaking (NPR). In a letter to CMS Administrator, Chiquita Brooks-LaSure, the American Hospital Association (AHA), American Medical Association (AMA), and Blue Cross Blue Shield Association (BCBSA) applauded the CMS for its focus on reforming prior authorization to ensure timely access to care for patients while minimizing manual paperwork for all healthcare stakeholders, but expressed their concern that the proposed changes would likely cause widespread industry confusion, be enormously expensive, and would create the same costly burdens that the proposed standards seek to alleviate.

“First, major efforts are underway to automate PA-related data exchange leveraging Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) implementation guides,” explained the trade groups in the letter. “Secondly, and even more significantly, the Advancing Interoperability and Improving Prior Authorization NPRM (CMS-0057-P) would require federally regulated health plans to offer HL7 FHIR-based application programming interfaces to support electronic PA information exchange. In contrast, the attachments NPRM would require a combination of both X12 and HL7 standards and apply to all health plans under the Health Insurance Portability and Accountability Act (HIPAA) regulatory pathway.”

The NPRMs would create conflicting provisions and would establish two different sets of standards and workflows to complete the prior authorization process and federally regulated health plans would be required to crosswalk the two standards for no discernible benefit. That would directly counter the foundational principles of the original HIPAA administrative simplification regulations, which require the adoption of uniform electronic standards to support communication between providers and all health plans. As such, the AHA, AMA, and BCBSA strongly advise against the adoption of the standards for prior authorization attachments.

The post AHA, AMA, BCBSA Urge CMS Not to Adopt Proposed Standards for Healthcare Attachments appeared first on HIPAA Journal.

OCR/FTC Warn Hospitals & Telehealth Companies About Tracking Technologies

The Department of Health and Human Services’ Office for Civil Rights (OCR) and the Federal Trade Commission (FTC) have written to 130 hospitals and telehealth providers warning them about the risks of using tracking technologies such as pixels on their websites and web apps which may disclose sensitive health information to third parties in violation of the HIPAA Rules and the FTC Act.

A study published in Health Affairs suggests 98.6% of US nonfederal acute care hospitals have used tracking technologies on their websites, and a 2022 analysis by The Markup found one-third of the top 100 hospitals in the United States were using tracking technologies on their websites that could collect individually identifiable information, including information about health conditions. Following these discoveries, several hospitals and health systems reported breaches of protected health information, some of which involved impermissible disclosures of millions of patient records.

A later study by The Markup found that the technologies were also widely used by telehealth companies. Even companies that are not required to comply with the HIPAA Rules have an obligation to protect personal health information against impermissible disclosure. The FTC has already taken action against entities that are not covered by HIPAA, such as GoodRx, BetterHelp, and Premom, over the use of these tracking technologies for alleged violations of the FTC Act and Health Breach Notification Rule.

In December 2022, OCR issued guidance to HIPAA-regulated entities on HIPAA and tracking technologies. While these tools can provide valuable insights for improving the services provided to patients, these technologies can collect and transmit information protected by HIPAA. Further, these technologies also permit the tracking of users even after they navigate away from the website or mobile app where the tracking technology is used. Any information transmitted to a third party may then be used for a purpose not permitted under the HIPAA Rules, and the collected information may be further disclosed to other third parties.

“When consumers visit a hospital’s website or seek telehealth services, they should not have to worry that their most private and sensitive health information may be disclosed to advertisers and other unnamed, hidden third parties,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection. “The FTC is again serving notice that companies need to exercise extreme caution when using online tracking technologies and that we will continue doing everything in our powers to protect consumers’ health information from potential misuse and exploitation.”

“Although online tracking technologies can be used for beneficial purposes, patients and others should not have to sacrifice the privacy of their health information when using a hospital’s website,” said Melanie Fontes Rainer, OCR Director. “OCR continues to be concerned about impermissible disclosures of health information to third parties and will use all of its resources to address this issue.”

The letters were jointly sent by OCR and the FTC to 130 entities cautioning them about tracking technologies on websites and mobile apps that can potentially disclose sensitive health data. The organizations that were sent the letters are believed to have used or are using tracking technologies such as Pixel from Meta/Facebook and Google

Analytics code to collect and analyze user interactions on websites and web apps. The letters do not mean that an organization has been found to be in violation of violated HIPAA or the FTC Act nor does the failure to receive a letter mean that an organization is in the clear. All organizations that collect personal health information should review their websites and web apps to identify any tracking technologies and ensure they are fully compliant with all relevant laws. If tracking technologies are discovered to have been used on websites or apps that impermissibly disclosed personal health information or protected health information to third parties, then the breaches should be reported in accordance with the HIPAA Breach Notification Rule and FTC Health Breach Notification Rule.

“Both agencies are closely watching developments in this area,” explained the FTC and OCR in the letters. “To the extent you are using the tracking technologies described in this letter on your website or app, we strongly encourage you to review the laws cited in this letter and take actions to protect the privacy and security of individuals’ health information.”

The post OCR/FTC Warn Hospitals & Telehealth Companies About Tracking Technologies appeared first on HIPAA Journal.

June 2023 Healthcare Data Breach Report

The Department of Health and Human Services’ Office for Civil Rights (OCR) breach portal shows a 12% month-over-month reduction in the number of healthcare data breaches of 500 or more records. In June, HIPAA-regulated entities reported 66 breaches, and while this was an improvement on the 73 breaches reported in June 2022, the month’s total is still well above the 12-month average of 58 data breaches a month.

Healthcare Data Breaches Past 12 Months - June 2023

May was a particularly bad month for data breaches with more than 19 million individuals having their protected health information exposed or impermissibly disclosed, so while there was a 73.67% month-over-month reduction in breached records in June, the previous month’s total was unnaturally high. June’s total of 5,015,083 breached records was below the 12-month average of 6 million records a month and less than the 6,258,833 records breached in June 2022, but that is still more than 167,000 breached healthcare records a day – 17.6% more than the daily average in 2022.

Healthcare Records Breached in the past 12 months - June -2023

In H1 2023, 41,452,622 healthcare records were exposed or impermissibly disclosed. That’s just a few thousand records short of the total for all of 2019 and just 10 million below the total for all of 2022.

Largest Healthcare Data Breaches in June 2023

In June, 25 data breaches of 500 or more records were reported to OCR, all but two of which were hacking/IT incidents. The largest breach of the month by some distance was a ransomware attack and data theft incident at the biotech and diagnostics company, Enzo Clinical Labs (Enzo Biochem).  Murfreesboro Medical Clinic & SurgiCenter also suffered a major breach where sensitive data was stolen and a ransom demand was issued to prevent a data leak, as did Intellihartx. Intellihartx was one of several companies that had sensitive data stolen by the Cl0p ransomware group, which mass exploited a zero day vulnerability in Fortra’s GoAnywhere MFT file transfer solution in late January.

As the table below indicates, it is becoming increasingly common for HIPAA-regulated entities to only disclose limited information in their notification letters. Data breaches are often reported as “unauthorized individuals accessed the network and may have accessed or removed patient information,” even when data theft has been confirmed and the stolen data has been uploaded to the data leak sites of ransomware groups. The lack of information can make it difficult for victims of data breaches to assess the level of risk they face.

Healthcare Data Breaches of 10,000 or More Records

Name of Covered Entity State Covered Entity Type Individuals Affected Type of Breach Cause of Breach
Enzo Clinical Labs, Inc. NY Healthcare Provider 2,470,000 Hacking/IT Incident Ransomware attack
Murfreesboro Medical Clinic & SurgiCenter TN Healthcare Provider 559,000 Hacking/IT Incident Cyberattack (extortion)
Intellihartx, LLC TN Business Associate 489,830 Hacking/IT Incident Cyberattack (extortion) – Fortra GoAnywhere MFT Solution hacked
Advanced Medical Management, LLC MD Business Associate 319,485 Hacking/IT Incident Hacking of network designed/maintained by a business associate
Great Valley Cardiology PA Healthcare Provider 181,764 Hacking/IT Incident Cyberattack – Brute force attack involving data theft
Petaluma Health Center CA Healthcare Provider 124,862 Hacking/IT Incident Cyberattack – Details unknown
Imagine360 PA Business Associate 112,611 Unauthorized Access/Disclosure Cyberattack (extortion) – Fortra GoAnywhere MFT and Citrix file transfer solutions hacked
Kannact, Inc. OR Business Associate 103,547 Hacking/IT Incident Cyberattack (extortion) – Fortra GoAnywhere MFT Solution hacked
Activate Healthcare LLC IL Healthcare Provider 93,761 Hacking/IT Incident Cyberattack with data theft confirmed
Desert Physicians Management CA Business Associate 56,556 Hacking/IT Incident Cyberattack with data theft confirmed
ARx Patient Solutions KS Healthcare Provider 41166 Unauthorized Access/Disclosure Compromised email account
Orrick, Herrington & Sutcliffe LLP CA Business Associate 40,823 Hacking/IT Incident Cyberattack – Details unknown
Tidewater Diagnostic Imaging, Ltd. MA Healthcare Provider 40,195 Hacking/IT Incident Hacking Incident – Details unknown
Peachtree Orthopaedic Clinic, P.A. GA Healthcare Provider 34,691 Hacking/IT Incident Cyberattack (extortion) by Karakurt threat group
Atlanta Women’s Health Group, P.C. GA Healthcare Provider 33,839 Hacking/IT Incident Cyberattack – Details unknown
Maimonides Medical Center NY Healthcare Provider 33,000 Hacking/IT Incident Cyberattack – Details unknown
Elgon Information Systems MA Business Associate 31,248 Hacking/IT Incident Hacking Incident – Details unknown
Community Research Foundation CA Healthcare Provider 30,057 Hacking/IT Incident Hacking Incident – Details unknown
Mount Desert Island Hospital, Inc. ME Healthcare Provider 24,180 Hacking/IT Incident Cyberattack – Details unknown
Mercy Medical Center – Clinton, Inc. IA Healthcare Provider 20,865 Hacking/IT Incident Ransomware attack
Ascension Seton TX Healthcare Provider 17,191 Hacking/IT Incident Hacking incident at business associate (Vertex)
John N. Evans, DPM MI Healthcare Provider 15,585 Hacking/IT Incident Hacking Incident – Details unknown
New Horizons Medical, Inc MA Healthcare Provider 12,317 Hacking/IT Incident Hacking Incident – Details unknown
CareNet Medical Group, PC NY Healthcare Provider 10,059 Hacking/IT Incident Cyberattack with data theft confirmed
Core Performance Physicians, dba Vincera Core Physicians PA Healthcare Provider 10,000 Hacking/IT Incident Ransomware attack affecting four Vincera companies (25,000 affected in total)

Causes of June 2023 Healthcare Data Breaches

Hacking incidents once again dominated the breach reports, accounting for more than 77% of the month’s data breaches and more than 96% of the month’s breached records. The average breach size was 94,480 records and the median breach size was 5,973 records. 4,818,457 records were exposed or compromised in hacking incidents. There were 14 unauthorized access/disclosure incidents reported, which cover a range of different incidents including unauthorized medical record access, unsecured paper records, mismailing incidents, and misdirected emails. Across those incidents, 196,026 records were impermissibly accessed or disclosed. The average breach size was 14,002 records and the median breach size was 2,567 records. There was one incident involving the improper disposal of 600 paper records and no reported loss or theft incidents.

Causes of June 2023 healthcare data breaches

As the chart below shows the most common location of breached protected health information was network servers, with email accounts the second most common location of breached data.

location of breached information in June 2023 healthcare data breaches

Where Did the Breaches Occur?

The raw data from the OCR breach portal shows data breaches by reporting entity; however, that does not mean that is where the breach occurred. When data breaches occur at business associates, the business associate may report the breach, or the covered entities affected, or a combination of the two. The raw data shows 44 breaches at healthcare providers, 12 at business associates, and 10 at health plans.

The charts below are based on adjusted figures and show where the data breach occurred rather than the entity reporting the breach as this better reflects the number of data breaches that occurred at business associates of HIPAA-regulated entities.

June 2023 healthcare data breaches - covered entity type

Records breached at hipaa-regulated entities in June 2023

Geographical Distribution of Healthcare Data Breaches

Data breaches of 500 or more records were reported by HIPAA-regulated entities in 31 states in June 2023. Pennsylvania was the worst affected state, with 11 data breaches reported. The high total is partly due to 6 of the breaches relating to two incidents that were reported separately for each company affected. Even taking this into account, Pennsylvania was the worst affected state.

State Breaches
Pennsylvania 11
California 5
Massachusetts, New York & Texas 4
Arizona & Minnesota 3
Florida, Georgia, Maryland, Michigan, North Carolina, Ohio, Tennessee & Utah 2
Alabama, Delaware, Idaho, Illinois, Iowa, Indiana, Kansas, Kentucky, Maine, Mississippi, Montana, New Jersey, Oklahoma, Oregon, South Carolina & Virginia 1

HIPAA Enforcement Activity in June 2023

The Office for Civil Rights announced three enforcement actions in June to resolve potential violations of the HIPAA Rules. Yakima Valley Memorial Hospital was investigated by OCR after a report was received about a HIPAA breach involving 23 security guards who had been accessing patient records without authorization. OCR determined that the hospital had failed to implement reasonable and appropriate policies and procedures to comply with the standards, implementation specifications, or other requirements of the Security Rule. The case was settled and the hospital agreed to pay a $240,000 penalty.

Manasa Health Center was investigated after complaints were filed with OCR about impermissible disclosures of PHI in response to negative online reviews left by four patients. The case was settled with OCR and Manasa Health Center agreed to pay a $30,000 penalty. This was OCR’s third enforcement action in the past year to see a financial penalty for disclosures of PHI in response to negative patient reviews. No company likes to receive bad reviews and negative customer comments may be unjustified, but PHI must never be disclosed online in response to reviews.

iHealth Solutions, which does business as Advantum Health, was investigated over a relatively small data breach involving the exposure of the ePHI of 267 patients. Patient information was stored on a server that had not been properly secured, allowing protected health information to be accessed over the Internet. OCR determined that iHealth Solutions had failed to conduct an accurate, thorough, organization-wide risk analysis to identify all risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI. The case was settled and iHealth Solutions agreed to pay a $75,000 penalty.

OCR has now imposed 8 financial penalties on HIPAA-regulated entities so far this year to resolve alleged violations of the HIPAA Rules with the penalties totaling $1,976,500. OCR has already exceeded last year’s total of $1,124,640 in fines that were collected from HIPAA-regulated entities in 17 enforcement actions.

State attorneys general can also impose financial penalties for HIPAA violations, although the fines are often imposed for equivalent violations of state laws, as was the case in California in June. In 2019, Kaiser Permanente sent mailings to its plan members, but an error resulted in letters being sent to old addresses, resulting in an impermissible disclosure of members’ protected health information. While this was a HIPAA violation, California imposed a financial penalty for violations of the California Confidentiality of Medical Information Act (CMIA) – an impermissible disclosure of the personal information of up to 175,000 individuals and the negligent maintenance and/or disposal of medical information. The case was settled for $450,000.

The post June 2023 Healthcare Data Breach Report appeared first on HIPAA Journal.