On June 22, 2021, Congressional leaders Diana DeGette (D-DO) and Fred Upton (R-MI) released a bipartisan follow-up to the 2016 21st Century Cures Act. “Cures 2.0”—a “discussion draft” at this stage—is intended to build upon the Cures Act.
Covington Digital Health
Developments and Trends in Digital Health, eHealth and Health IT
Covington Digital Health, published by Covington & Burling LLP, focuses on legal and regulatory developments at the intersection of digital health, biotechnology, and life sciences. The blog covers topics such as regulatory compliance for AI-enabled medical devices, data protection and privacy in clinical trials, FDA policies on digital therapeutics and health technology, and innovations in healthcare data interoperability. It also addresses emerging issues related to artificial intelligence in healthcare, real-world evidence generation, and the evolving regulatory landscape for digital health technologies. The blog serves as a resource for companies navigating complex legal frameworks in digital health and life sciences sectors.
Latest from Covington Digital Health - Page 8
European Commission Proposes New Artificial Intelligence Regulation
By Lisa Peets & Marty Hansen
In April 2021, the European Commission released its proposed Regulation Laying Down Harmonized Rules on Artificial Intelligence (the “Regulation”), which would establish rules on the development, placing on the market, and use of artificial intelligence systems (“AI systems”) across the…
European Commission Conducts Further Consultation on the European Health Data Space Initiative
On May 3, 2021, the European Commission (the “Commission”) opened a further public consultation (“Consultation”) on the European Health Data Space (“EHDS”).
This follows a consultation earlier in the year, on the Commission’s “Inception Impact Assessment” in relation to the…
UK Government Announces Review Into Use Of Health Data For Research And Analysis
On February 9, 2021, the UK Government’s Department for Health and Social Care (“DHSC”) announced a review into the efficient and safe use of health data for research and analysis for the benefit of patients in the health sector (“Review”).…
FTC Reaches Settlement with Digital Health App, Requires First Notice of Privacy Action
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…
M.D. Anderson Wins Appeal Over $4.3 Million HIPAA Penalty
On January 14, 2021, the United States Court of Appeals for the Fifth Circuit vacated a $4.3 million civil monetary penalty that the Office for Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) imposed against the…
AI Update: The Future of AI Policy in the UK
On January 6, 2021, the UK’s AI Council (an independent government advisory body) published its AI Roadmap (“Roadmap”). In addition to calling for a Public Interest Data Bill to ‘protect against automation and collective harms’, the Roadmap acknowledges the need…
HITECH Amendment Provides Some Protection For Covered Entities and Business Associates that Adopt Recognized Security Standards
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…
European Commission Conducts Open Consultation on the European Health Data Space Initiative
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,…
AI Update: UK Parliament Research Briefing on AI in the UK Healthcare System
On 18 January 2021, the UK Parliamentary Office of Science and Technology (“POST”)* published its AI and Healthcare Research Briefing about the use of artificial intelligence (“AI”) in the UK healthcare system (the “Briefing”). The Briefing considers the potential impacts…