The International Coalition of Medicines Regulatory Authorities (“ICMRA”) has published a report on the use of artificial intelligence (“AI”) to develop medicines (the “AI Report”) that provides a series of recommendations on how regulators and stakeholders can address challenges posed by AI. The ICMRA notes that there are numerous opportunities to apply AI to medicines development, but that AI poses a number of challenges to existing regulatory frameworks. The AI Report discusses these opportunities and challenges in detail based on several case studies, and provides a set of recommendations for implementation by the ICMRA and its member authorities, which includes the European Medicines Agency (the “EMA”), the USA’s Food and Drug Administration, and the World Health Organisation. Based on the AI report, we expect to see an increased focus on adapting regulatory frameworks to deal with AI products going forwards both on an international and national level.
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Digital Health
Proposed Bill Would Expand the Scope of the CMIA
By Libbie Canter & Olivia Vega on
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. …
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Reps. DeGette and Upton Release Highly-Anticipated “Cures 2.0” Draft
By Mingham Ji & Olivia Dworkin on
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. The draft lays out several notable policies related to digital health, real-world data/evidence (RWD/E), and…
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 EHDS. (For further information on the earlier consultation and an overview of the EHDS, please see our blog post available here).…
UK Government Announces Review Into Use Of Health Data For Research And Analysis
By Daniel Pavin & Sam Jungyun Choi on
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”). The DHSC encourages stakeholder feedback in the context of the Review, and will be of particular interest to organisations that have, or seek to have, access to NHS patient data for research purposes.
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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, encouraging “citizens and stakeholders” to “provide views on the Commission’s understanding of the current situation, problem and possible solutions”.
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AI Update: UK Parliament Research Briefing on AI in the UK Healthcare System
By Daniel Pavin & Sam Jungyun Choi on
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 of AI on the cost and quality of healthcare, and the challenges posed by the wider adoption of AI, including safety, privacy and health inequalities.
The Briefing summarises the different possible applications of AI in healthcare settings, which raises unique considerations for healthcare providers. It notes that AI, developed through machine learning algorithms, is not yet widely used within the NHS, but some AI products are at various stages of trial and evaluation. The areas of healthcare identified by the Briefing as having the potential for AI to be incorporated include (among others): interpretation of medical imaging, planning patients’ treatment, and patient-facing applications such as voice assistants, smartphone apps and wearable devices.…
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FDA Releases AI Action Plan
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 device regulatory framework. On January 12, 2021, FDA issued the Artificial Intelligence/Machine Learning (AI/ML)-Based Software…
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
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 and Care Technologies” (the “Code”) (for further information on the Code see our earlier blog, here).
As with the Code, the Guidance is a valuable resource to help parties understand what the National Health Service (“NHS”) looks for when acquiring digital and data-driven technologies for use in health and care.…
California AG Settlement Suggests Privacy and Security Practices of Digital Health Apps May Provide Fertile Ground for Enforcement Activity
By Libbie Canter & Anna D. Kraus on
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 “failures” in Glow’s mobile application…