FDA has long recognized the significant potential of artificial intelligence- and machine learning- (AI/ML-) based software as a medical device (SaMD) to transform health care as well as the unique challenges presented by AI/ML-based software under the Agency’s traditional medical
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 9
Proposed New EU Cyber Rules Introduce More Onerous Requirements and Extend to More Sectors
In addition to releasing the new EU Cybersecurity Strategy before the holidays (see our post here), the Commission published a revised Directive on measures for high common level of cybersecurity across the Union (“NIS2”) and a Directive on the…
The Council of Europe Publishes Feasibility Study on Developing a Legal Instrument for Ethical AI
On 17 December 2020, the Council of Europe’s* Ad hoc Committee on Artificial Intelligence (CAHAI) published a Feasibility Study (the “Study”) on Artificial Intelligence (AI) legal standards. The Study examines the feasibility and potential elements of a legal framework for…
UK’s Department of Health and Social Care Publishes Updated Guidance on Good Practice for Digital and Data-Driven Health Technologies
By Daniel Pavin
On January 6, 2021 the UK’s Department of Health and Social Care (“DHSC”) published “A Guide to Good Practice for Digital and Data-Driven Health Technologies” (the “Guidance”). The Guidance updates the DHSC’s “Code of Conduct for Data-Driven Health…
HHS Announces Proposed Changes to HIPAA’s Privacy Rule
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…
The European Commission publishes a proposal for a Regulation on European Data Governance (the Data Governance Act)
On 25 November 2020, the European Commission published a proposal for a Regulation on European Data Governance (“Data Governance Act”). The proposed Act aims to facilitate data sharing across the EU and between sectors, and is one of…
EDPB adopts recommendations on international data transfers following Schrems II decision
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…
CISA and MS-ISAC Release Joint Guide on Ransomware
By Ashden Fein
On September 30, 2020, the Cybersecurity and Infrastructure Security Agency (“CISA”) and the Multi-State Information Sharing and Analysis Center (“MS-ISAC”) released a joint guide synthesizing best practices to prevent and respond to ransomware. This guide was published the day before…
California AG Settlement Suggests Privacy and Security Practices of Digital Health Apps May Provide Fertile Ground for Enforcement Activity
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…
AI, IoT, and CAV Legislative Update: EU Spotlight (Third Quarter 2020)
In this edition of our regular roundup on legislative initiatives related to artificial intelligence (AI), cybersecurity, the Internet of Things (IoT), and connected and autonomous vehicles (CAVs), we focus on key developments in the European Union (EU).…