On July 20, 2023, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) and the Federal Trade Commission (FTC) announced they were sending a joint letter to approximately 130 unidentified hospital systems and telehealth providers highlighting the agencies’ concerns about the use of tracking technologies on websites and mobile apps in … Continue Reading
Direct-to-consumer health and wellness applications are forewarned: the Federal Trade Commission (FTC) is proposing changes to the Health Breach Notification Rule (HBNR), 16 C.F.R. part 318, that, if finalized, would cement the HBNR’s applicability to a broad swath of direct-to-consumer health and wellness applications (apps) and confirm that a breach of security includes not only … Continue Reading
The Department of Health and Human Services Office for Civil Rights (OCR) issued a proposed rule on April 17, 2023, to amend provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to strengthen privacy protections for individuals’ protected health information (PHI) related to reproductive healthcare (the Proposed Rule). The Proposed Rule would … Continue Reading
The Federal Trade Commission (FTC) continues to prioritize the protection of consumers’ digital health information. The agency has demonstrated this commitment through enforcement actions against GoodRx and BetterHelp for sharing consumer health information for advertising purposes (see our blog posts on each respective action here and here), and in a post published by the FTC … Continue Reading
Following its February settlement with GoodRx, the Federal Trade Commission (FTC) has fired another shot across the bow in its ongoing campaign to protect consumers’ digital health information. Earlier this month the FTC announced a consent order with BetterHelp, Inc., an online mental health counseling service, to resolve alleged violations of the Federal Trade Commission … Continue Reading
The Federal Trade Commission (FTC) didn’t mince words. On September 2021, it called out the health app industry for failing to understand the agency’s Health Breach Notification Rule (HBNR) and for not disclosing its breaches. Apparently dissatisfied with the industry’s response, the agency enforced the HBNR against GoodRx for the first time since the rule … Continue Reading
The Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) announced on July 15, 2022, that it has resolved 11 investigations conducted under the Health Insurance Portability and Accountability Act (“HIPAA”) Right of Access Initiative. These settlements remind providers that, as OCR Director Lisa J. Pino stated, “OCR is … Continue Reading
Employers who are conducting automatic COVID-19 testing of employees or gathering test results of employees’ families should beware: the Equal Employment Opportunity Commission (“EEOC”) has issued new guidance limiting the former and has penalized a healthcare practice recently for doing the latter.… Continue Reading
The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) recently released new guidance (the “Guidance”) to help ensure that individuals may continue to benefit from audio-only telehealth services and clarify for health care providers and health plans how they can provide such services while complying with the HIPAA Privacy, Security, … Continue Reading
Covered entities and business associates subject to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) have the chance to provide input on two amendments to the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”). The U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) recently … Continue Reading
The wait is over for employers seeking clarity on the details of the Biden Administration’s vaccine and testing rules for private employers, first announced by President Biden in early September and now slated to take effect alongside federal contractor vaccine requirements on January 4, 2022. The first rule, issued by the Occupational Safety and Health … Continue Reading
Vendors of health applications (“health apps”) and connected devices that collect or use individuals’ health information, along with their service providers, are now on notice that they must provide timely notice to consumers and the Federal Trade Commission (FTC) when there is a security breach compromising health information. In response to the proliferation of health … Continue Reading
Cyberattacks against healthcare providers accounted for 79% of all reported data breaches in 2020. (See here). The U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) responded last month by releasing a comprehensive guide to protect providers against this growing vulnerability entitled “Healthcare System Cybersecurity Readiness … Continue Reading
While fighting a surge of new coronavirus infections in many parts of the country, healthcare providers must also be prepared to defend against ransomware. On October 28, 2020, the FBI, the U.S. Department of Health and Human Services (HHS), and the Cybersecurity and Infrastructure Security Agency (CISA) issued a joint alert warning of “credible information … Continue Reading
Healthcare providers are under siege, not only from the COVID-19 pandemic, but also from cyber criminals. Following reports of targeted email phishing attempts, the FBI issued a FLASH alert warning healthcare providers on April 21, 2020, that they are at heightened risk for cyber attacks that use COVID-19 as bait. The FBI’s FLASH alert follows … Continue Reading
California has joined the growing ranks of states, as well as the federal government, in efforts to facilitate the efficient provision of healthcare services during the pandemic. Accordingly, in response to federal agency updates with respect to relaxations to existing requirements related to telehealth services, California’s Governor Gavin Newsom issued an Executive Order No. 43-20 … Continue Reading
Health and welfare benefit plans and insurers are affected by various provisions of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) passed on March 27, 2020. In addition to provisions impacting tax-qualified retirement plans and executive compensation (summarized here), the CARES Act affects coverage of diagnostic testing, preventive services, telehealth services, and drug reimbursement. … Continue Reading
Hospitals will have a limited waiver of HIPAA sanctions and penalties during the COVID-19 outbreak as a result of a bulletin issued on March 16, 2020 by the U.S. Department of Health and Human Services. The Office of Civil Rights also issued a reminder that even during a medical emergency like the COVID-19 pandemic, all … Continue Reading
Healthcare providers have special concerns for their employees during the Coronavirus (COVID-19) global health pandemic. Because COVID-19 spreads primarily as a result of close exposure to an infected person, healthcare employees are at higher risk of infection. While OSHA has a standard to protect employees from the spread of bloodborne pathogens, it currently has no … Continue Reading
On January 28, 2020, the U.S. Department of Health & Human Services Office for Civil Rights (OCR) issued a notice (the OCR Notice) regarding individuals’ right of access to health records in response to a January 23, 2020 court ruling in the Ciox Health, LLC v. Azar, et al., No. 18-cv-0040 (D.D.C. Jan. 23, 2020) … Continue Reading
Computer hacking, and the permutation of crimes that can be committed by hackers, generally does not spur images of infliction of physical harm. However, in a chilling turn of events, computer hackers have opened a new front in the damage that can be inflicted through cybercrime. In a nefarious series of developments, cyber-liabilities now arise … Continue Reading
In May of 2018, the European Union enacted the General Data Protection Rules, or GDPR, a legal framework that outlines not only how companies may collect and process personal information of EU residents, but how that data is stored and used. Since its enactment, GDPR has triggered a global push towards compliance with those standards. … Continue Reading
The latest HIPAA resolution agreement by the U.S. Department of Health and Human Services Office for Civil Rights (OCR) is a reminder that healthcare providers must take the high road when responding to unflattering online reviews by patients. While it is tempting to respond to a bad and perhaps untrue online review, healthcare providers need … Continue Reading
Until recently, the annual limit for civil monetary penalties (CMP) that could be levied against covered entities and business associates in violation of the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, as amended from time to time … Continue Reading
