On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and machine learning (“AI/ML”).

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On September 15, 2021, CMS published a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule (“MCIT/RN Rule”), which was published on January 14, 2021 and was set to take effect on December 15, 2021.  The MCIT/RN Rule would have created a pathway to provide

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

On August 23, 2021 the UK Government published its report entitled “Harnessing technology for the long-term sustainability of the UK’s healthcare system” (the “Report”). The Report calls for system-wide adoption of technology in the UK health system to enable transformative change that will benefit the health and wellbeing of the UK and promote economic growth.  However, the Report cautions that technology alone cannot overcome the inequalities that lead to disparities in health outcomes and that digital tools for health should be accessible to all, or risk exacerbating health inequalities as a result of a “digital divide”. The Report notes how the COVID-19 pandemic has both exposed the limitations of the current system and highlighted the capability of the UK National Health Service (“NHS”) for responding with flexibility and agility. The Report also makes several recommendations to the UK Government, including to set up “Demonstrators” to test the system-wide application of healthcare technologies.

The Report arrives ahead of the expected publication of the UK Government’s review into the use of health data for research and analysis (see our earlier blog here), and outlines the opportunities presented by technology in the context of public healthcare systems.


Continue Reading UK Government Publishes Report on Harnessing Technology For Benefit of the UK Healthcare System

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.

Continue Reading ICMRA Publishes Report and Recommendations on AI and Medicinal Products

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

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).


Continue Reading European Commission Conducts Further Consultation on the European Health Data Space Initiative

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.

Continue Reading UK Government Announces Review Into Use Of Health Data For Research And Analysis

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 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.


Continue Reading AI Update: UK Parliament Research Briefing on AI in the UK Healthcare System