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On December 2, 2022, the U.S. Department of Health and Human Services (“HHS”), through the Office for Civil Rights (“OCR”) and the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a proposed rule to implement statutory amendments enacted by Section 3221 of the 2020 Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”).  Specifically…

On Wednesday, October 6th, Governor Gavin Newsom signed SB 41, the Genetic Information Privacy Act, which expands genetic privacy protections for consumers in California, including those interacting with direct-to-consumer (“DTC”) genetic testing companies.  In a recent Covington Digital Health blog post, our colleagues discussed SB 41 and the growing patchwork of state genetic privacy…

Last Friday, October 1, the Protecting DNA Privacy Act (HB 833), a new genetic privacy law, went into effect in the state of Florida establishing four new crimes related to the unlawful use of another person’s DNA.  While the criminal penalties in HB 833 are notable, Florida is not alone in its focus…

On September 15, the Federal Trade Commission (“FTC”) adopted, on a 3-2 party-line vote, a policy statement that takes a broad view of which health apps and connected devices are subject to the FTC’s Health Breach Notification Rule (the “Rule”) and what triggers the Rule’s notification requirement.

The Rule was promulgated in 2009 under the Health Information Technology for Economic and Clinical Health (“HITECH”) Act.  Under the Rule, vendors of personal health record that are not otherwise regulated under the Health Insurance Portability and Accountability Act (“HIPAA”) are required to notify individuals, the FTC, and, in some cases, the media following a breach involving unsecured identifiable health information.  16 C.F.R. §§ 318.3, 318.5.  Third-party service providers also are required to notify covered vendors of any breach.  16 C.F.R. § 318.3.…

Continue Reading FTC Adopts Policy Statement on Privacy Breaches by Health Apps and Connected Devices

Legislation that would amend California’s Confidentiality of Medical Information Act (“CMIA”) is working its way through California’s Senate and passed in the Senate Health Committee earlier this week.  The proposed bill passed in the state’s Assembly back in April.  Introduced by Democratic California Assemblymember Edwin Chau, who sits on the Privacy and Consumer Protection Committee, the proposed legislation (AB 1436) expands the definition of “provider of health care.”  Under the CMIA, providers of health care are subject to various obligations, including provisions that restrict the disclosure of medical information without a prior valid authorization, subject to certain exceptions. …
Continue Reading Proposed Bill Would Expand the Scope of the CMIA

The Federal Trade Commission (“FTC”) announced this month a proposed settlement against Flo Health, Inc. (“Flo”), the developer of popular menstrual cycle and fertility-tracking application (the “Flo App”), resolving allegations that “the company shared the health information of users with outside data analytics providers after promising that such information would be kept private.”  The proposed settlement requires Flo, among other things, to obtain review by an “independent third-party professional” of its privacy practices, obtain users’ consent before sharing their health information, alert users whose data was disclosed, and require third-parties that previously received that data to destroy it.
Continue Reading FTC Reaches Settlement with Digital Health App, Requires First Notice of Privacy Action

On December  10, 2020, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule to modify the Standards for the Privacy of Individually Identifiable Health Information (the “Privacy Rule”) promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”).  According to HHS’s announcement, the proposed rule would amend the Privacy Rule to “support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry.”  Public comments on the proposed rule are currently being accepted through February 12, 2021.

The proposed rule is part of HHS’s Regulatory Sprint to Coordinated Care, initiated pursuant to Secretary Alex Azar’s value-based transformation agenda, which seeks to “promote value-based care by examining federal regulations that impede efforts among health care providers and health plans to better coordinate care for patients.”  Throughout the Privacy Rule, HHS sought to protect health information while also permitting information sharing for certain beneficial purposes.  However, stakeholders have questioned whether the Privacy Rule strikes the appropriate balance in certain situations.

Proposed modifications to the HIPAA Privacy Rule include strengthening individuals’ right to access their protected health information (“PHI”), including electronic PHI; facilitating greater family involvement in care for individuals dealing with health crises or emergencies; and allowing providers more flexibility to disclose PHI when harm to a patient is “serious and reasonably foreseeable,” such as during the opioid crisis or COVID-19 public health emergency.  Importantly, multiple provisions of the proposed rule, discussed in greater detail below, address electronic health records (“EHRs”) and personal health applications.…

Continue Reading HHS Announces Proposed Changes to HIPAA’s Privacy Rule

On 11 November 2020, the European Data Protection Board (“EDPB”) issued two draft recommendations relating to the rules on how organizations may lawfully transfer personal data from the EU to countries outside the EU (“third countries”).  These draft recommendations, which are non-final and open for public consultation until 30 November 2020, follow the EU Court of Justice (“CJEU”) decision in Case C-311/18 (“Schrems II”).  (For a more in-depth summary of the CJEU decision, please see our blog post here and our audiocast here. The EDPB also published on 24 July 2020 FAQs on the Schrems II decision here).

The two recommendations adopted by the EDPB are:

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Continue Reading EDPB adopts recommendations on international data transfers following Schrems II decision

The Institute of Global Health Innovation at Imperial College London has published a report called “NHS data: Maximising its impact on the health and wealth of the United Kingdom” (the “Report”).[1] The Report begins from the premise that the knowledge gleaned from the combination of patient health data and “big data” technologies has incredible potential for “transformative …impact” on patient health, scientific advancement and the UK’s economy. However, the Report argues that the current efforts of scientists, medical professionals and the UK government to develop the UK’s capacities are not sufficiently coordinated to maximise that potential. To address this, the Report presents a single, high-level, strategic framework for the collection, governance and use of patient health data in the NHS.
Continue Reading New Report Recommends Putting Public Engagement at the Heart of NHS Health Data Strategy

On July 25, 2019, the UK’s Information Commissioner’s Office (“ICO”) published a blog on the trade-offs between different data protection principles when using Artificial Intelligence (“AI”).  The ICO recognizes that AI systems must comply with several data protection principles and requirements, which at times may pull organizations in different directions.  The blog identifies notable trade-offs that may arise, provides some practical tips for resolving these trade-offs, and offers worked examples on visualizing and mathematically minimizing trade-offs.

The ICO invites organizations with experience of considering these complex issues to provide their views.  This recent blog post on trade-offs is part of its on-going Call for Input on developing a new framework for auditing AI.  See also our earlier blog on the ICO’s call for input on bias and discrimination in AI systems here.…

Continue Reading ICO publishes blog post on AI and trade-offs between data protection principles