Last week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) issued a second discussion paper on the use of artificial intelligence (“AI”) and machine learning (“ML”) with respect to drug and biological products, this time focusing on the use of AI/ML in the drug and biologic development process, “Using Artificial Intelligence &
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FDA Releases Draft Guidance on Electronic Systems, Records, and Signatures in Clinical Investigations
On March 15, 2023, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (2023 Draft Guidance). The 2023 Draft Guidance revises the draft guidance for industry the Agency issued in June 2017 entitled Use of Electronic
FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development
On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT Framework”). This DHT Framework is on the heels of a Discussion Paper the Agency released earlier this month on the use of artificial intelligence (AI) in drug manufacturing to seek public input
How do the recent changes to the MDR and IVDR impact you and your medical devices? — Top 10 Questions
To avoid a real and imminent risk of shortages of devices on the EU market, the European Commission recently adopted Regulation (EU) 2023/607, extending the transitional provisions in Regulation (EU) 2017/745 (the “MDR”) and removing the sell-off period in the MDR and Regulation (EU) 2017/746 (the “IVDR”). The Commission has published a Q&A on the
5 Reasons Digital Solutions for Women+ Health Will Grow in 2023
Innovative digital solutions intended to address health issues typically experienced by women have been an area of increased focus. Ranging from reproductive-related mobile applications to AI-enabled breast cancer screening devices, digital solutions for women+ health show promise to serve an enormous market with medical needs that have often failed to get the level of attention
HHS Proposes Rule to Improve Standards for Electronic Prior Authorizations and Other Transactions with Health Care Attachments
On December 19, 2022, the U.S. Department of Health and Human Services (“HHS”) through the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule to adopt standards for certain electronic health transactions. Specifically, the proposed rule would adopt standards for health care attachment transactions (e.g., medical charts, x-rays, provider notes) and electronic signatures
FTC, HHS, and FDA Update Tool to Help Mobile Health App Developers Understand Legal Requirements
On December 7, 2022, the Federal Trade Commission (“FTC”), along with the U.S. Department of Health and Human Services (“HHS”) and the U.S. Food and Drug Administration (“FDA”), announced updates to the Mobile Health App Interactive Tool—a questionnaire designed to help mobile health app developers identify federal laws and regulations that may apply to
HHS Proposes Changes to More Closely Align Part 2 and HIPAA
On December 2, 2022, the U.S. Department of Health and Human Services (“HHS”), through the Office for Civil Rights (“OCR”) and the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a proposed rule to implement statutory amendments enacted by Section 3221 of the 2020 Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”). Specifically,
California Expands the Scope of the CMIA to Cover Certain Digital Mental Health Services and Information
On September 28, the governor of California signed into law AB 2089, which expands the scope of California’s Confidentiality of Medical Information Act (“CMIA”) to cover mental health services that are delivered through digital health solutions and the associated health information generated from these services.
Change is Coming for Software and AI Medical Devices in the UK
The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”). On 17 October 2022, the UK Medicines & Healthcare products Regulatory Agency (“MHRA”) published its Guidance on “Software and AI as a Medical Device Change Programme