Health privacy

On January 5, 2021, an amendment to the Health Information Technology for Economic and Clinical Health (“HITECH”) Act was signed into law.  The amendment requires the U.S. Department of Health and Human Services (“HHS”) to “consider certain recognized security practices of covered entities and business associates when making certain determinations” regarding fines, audit results, or other remedies for resolving potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  For organizations subject to HIPAA, the amendment provides substantial incentives to establish or improve their cybersecurity programs.  While it does not establish a complete safe harbor from HIPAA enforcement, the amendment does offer organizations a chance to mitigate financial penalties and other negative regulatory actions that may result from a data breach.
Continue Reading HITECH Amendment Provides Some Protection For Covered Entities and Business Associates that Adopt Recognized Security Standards

California Attorney General Xavier Becerra (“AG”) announced in September a settlement against Glow, Inc., resolving allegations that the fertility app had “expose[d] millions of women’s personal and medical information.”  In the complaint, the AG alleged violations of certain state consumer protection and privacy laws, stemming from privacy and security…
Continue Reading California AG Settlement Suggests Privacy and Security Practices of Digital Health Apps May Provide Fertile Ground for Enforcement Activity

Throughout September, the Department of Health and Human Services, Office for Civil Rights (“OCR”), announced eight different settlements to resolve a variety of alleged violations of the Privacy and Security Rules promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  Notably, three settlements stem from data breaches…
Continue Reading HHS Announces Multiple HIPAA Settlements Related to Data Breaches and the Right of Access Initiative

On September 2, 2020, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced a new “Health Apps” feature on the HHS.gov website.  The new website, which replaces the OCR’s Health App Developer Portal, highlights existing guidance for mobile health (“mHealth”) apps regarding the Health…
Continue Reading HHS Launches New “Health Apps” Website to Highlight HIPAA Guidance for Mobile Health Applications

Our colleagues at the Inside Privacy blog have summarized a proposed bill in California (the Genetic Information Privacy Act) that would impose certain privacy obligations on direct-to-consumer genetic testing companies that go beyond the California Consumer Privacy Act.  This summary may be of interest to entities that process genetic data
Continue Reading California Legislature Advances Privacy Legislation

On July 13, 2020, the U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising the Confidentiality of Substance Use Disorder Patient Records regulations located at 42 C.F.R. Part 2, commonly referred to as “Part 2.”  Under Part 2, federally…
Continue Reading SAMHSA Revises Part 2 Regulations for the Confidentiality of SUD Patient Records

Senate Commerce Committee Chairman Roger Wicker is working on draft legislation that would regulate the collection and use of health and location information in connection with efforts to track and limit the spread of COVID-19.   Some key highlights of the tentatively titled “COVID-19 Consumer Data Protection Act” include:

  • For the

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Continue Reading Republicans Poised To Introduce COVID-19 Privacy Bill

On April 30, 2019, the Department of Health and Human Services (HHS) published in the Federal Register a notification of enforcement discretion indicating that it will lower the annual Civil Money Penalty (CMP) limits for three of the four penalty tiers in the Health Information Technology for Economic and Clinical…
Continue Reading HHS Updates Maximum Annual Penalty Limits for Some HIPAA Violations