Digital Health

On October 12, 2023 the Italian Data Protection Authority (“Garante”) published guidance on the use of AI in healthcare services (“Guidance”).  The document builds on principles enshrined in the GPDR, national and EU case-law.  Although the Guidance focuses on Italian national healthcare services, it offers considerations relevant to the use of AI in the healthcare space more broadly.

We provide below an overview of key takeaways.Continue Reading Italian Garante Issues Guidance on the Use of AI in the Context of National Healthcare Services

On May 17, the Federal Trade Commission (“FTC”) announced an enforcement action against Easy Healthcare Corporation (“Easy Healthcare”) alleging that it shared users’ sensitive personal information and health information with third parties contrary to its representations and without users’ affirmative express consent, in violation of Section 5 of the FTC Act.  It also alleges that Easy Healthcare failed to notify consumers of these unauthorized disclosures, in violation of the Health Breach Notification Rule (“HBNR”).  According to the proposed order, Easy Healthcare will pay a $100,000 civil penalty for violating the HBNR and, among other requirements, will be permanently prohibited from sharing users’ personal health data with third parties for advertising purposes.  The FTC also noted that Easy Healthcare will pay a total of $100,000 to Connecticut, the District of Columbia, and Oregon for violating their laws.Continue Reading FTC Announces Second Enforcement Action Under Health Breach Notification Rule Against Fertility App Developer Easy Healthcare

In a new post on the Covington Digital Health blog, our colleagues discuss recently issued proposed rule to implement statutory amendments enacted by Section 3221 of the 2020 Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”).  Specifically, the proposed rule would harmonize certain provisions of the Confidentiality of Substance Use Disorder Patient Records under

In a new post on the Covington Digital Health blog, our colleagues discuss a recent amendment to California’s Confidentiality of Medical Information Act (“CMIA”) that expands the scope of the law to cover mental health services that are delivered through digital health solutions and the associated health information generated from these services.  Continue Reading California Expands the Scope of the CMIA to Cover Certain Digital Mental Health Services and Information

In a new post on the Covington Digital Health blog, our colleagues discuss recently announced Federal Trade Commission (“FTC”) guidance meant to help companies determine their obligations under the Health Breach Notification Rule (the “Rule”).  The guidance follows the FTC’s September 2021 Policy Statement, which expanded the Rule’s application to the developers of health

On December 23, 2020, the European Commission (the “Commission”) published its inception impact assessment (“Inception Impact Assessment”) of policy options for establishing a European Health Data Space (“EHDS”).  The Inception Impact Assessment is open for consultation until February 3, 2021, encouraging “citizens and stakeholders” to “provide views on the Commission’s understanding of the current situation, problem and possible solutions”.
Continue Reading European Commission Conducts Open Consultation on the European Health Data Space Initiative

On May 8, 2020, the Federal Trade Commission (“FTC”) issued a notice soliciting public comment regarding whether changes should be made to its Health Breach Notification Rule (the “Rule”).  The request for comment is part of a periodic review process “to ensure that [FTC rules] are keeping pace with changes in the economy, technology, and business models.”

The Rule, which first went into effect in 2009, applies only to vendors of personal health records (“PHRs”) and other related entities that are not subject to the Health Insurance Portability and Accountability Act (“HIPAA”).  A PHR is an electronic record of individually identifiable health information “that can be drawn from multiple sources and is managed, shared, and controlled by or primarily for the individual.”  See 16 C.F.R. § 318.2(d).  Under the Rule, PHR vendors and related entities must notify individuals, the FTC, and possibly the media within 60 days after discovering a breach of unsecured personally identifiable health information, or within 10 days if more than 500 individuals are affected by the breach.
Continue Reading FTC to Consider Changes to the Health Breach Notification Rule

On April 21, 2020, the Regulation on the Requirements and Reimbursement Process for Digital Health Applications (Digitale Gesundheitsanwendungen-Verordnung or „DiGAV“, available here) entered into force in Germany.  Among other provisions, the DiGAV includes specific IT security and privacy requirements.  Shortly after the law took effect, Germany’s Federal Medicines and Medical Devices Agency (“BfArM”) also released an extensive explanatory Guidance (Leitfaden, available here) to the DiGAV.

Independently, on April 15, 2020, the German Federal Office for IT Security (“BSI”) published a draft version of its guidance on “Security Requirements for Digital Health Applications” (BSI TR-03161) (available here).  The BSI is now seeking feedback from industry on this draft guidance before releasing a final version.

While the scope of application of the DiGAV and the BSI draft guidance may be limited, the documents can serve to provide useful insights and benchmarks for health applications generally.Continue Reading German Federal Agencies Publish Privacy and IT Security Requirements for Digital Health Applications

In this final instalment of our series of blogs on the European Commission’s plans for AI and data, announced on 19 February 2020, we discuss some potential effects on companies in the digital health sector. As discussed in our previous blog posts (here, here and here), the papers published by the European Commission cover broad concepts and apply generally — but, in places, they specifically mention healthcare and medical devices.

The Commission recognizes the important role that AI and big data analysis can play in improving healthcare, but also notes the specific risks that could arise given the effects that such new technologies may have on individuals’ health, safety, and fundamental rights. The Commission also notes that existing EU legislation already affords a high level of protection for individuals, including through medical devices laws and data protection laws. The Commission’s proposals therefore focus on addressing the gap between these existing rules and the residual risks that remain in respect of new technologies. Note that the Commission’s proposals in the White Paper on AI are open for public consultation until 19 May 2020.Continue Reading European Commission’s Plans for AI and Data: Focus on Digital Health (Part 4 of 4)