FDA recently announced that it will host a public workshop on August 6, 2024 focused on “Artificial Intelligence (AI) in Drug & Biological Product Development.”  Aimed at bringing drug sponsors and AI experts together, the workshop, hosted in collaboration with the Clinical Trials Transformation Initiative, will feature presentations and a panel discussion around guiding principles for the responsible use of AI in the development of safe and effective drugs and biological products. 

Per the Federal Register Notice, FDA plans to discuss the following topics at the workshop:

  1. Optimizing model design through multidisciplinary expertise (e.g., medicine, statistics, pharmacology, data science, and engineering) to ensure the development of optimal AI models.
  2. Exploring strategies for overcoming common data-related challenges, such as the availability of fit-for-use data that can be used in drug development, access via federated learning, data quality issues (e.g., representativeness of data, bias, etc.), and the use of synthetic data.
  3. Balancing model performance, explainability, and transparency of AI models, as well as strategies for assessing the need to integrate humans into the decision-making process (i.e., “human-in-the-loop” and/or “human-on-the-loop”).
  4. Identifying key gaps and challenges hindering the use of AI in drug and biological product development and exploring potential strategies, collaborations, and initiatives to address these challenges and advance the responsible use of AI in developing safe, effective, and quality drugs.

As we have discussed in other Covington Digital Health posts, FDA’s interests in AI used by drug and biological product sponsors is different from FDA’s framework for regulating some AI/ML-based software functions under its medical device authorities (i.e., software as a medical device), and this FDA workshop is the latest in a series of Agency actions specific to AI deployed by biopharma sponsors.  For example, FDA released two discussion papers last year that focused on the use of AI in drug and biological product development and in drug manufacturing, and more recently issued a Federal Register Notice introducing the “Emerging Drug Safety Technology Meeting” program, which will provide those involved in pharmacovigilance (PV) activities the ability to interact with CDER staff regarding the use of AI in the advancement of PV, including efforts to validate and verify relevant models.  This FDA workshop also precedes anticipated draft guidance from the Agency later this year on the use of AI and machine learning to support drug development, which will be informed by insights gained from the Agency’s review of submissions containing AI elements, as well as feedback received on the two discussion papers and the upcoming workshop.

Registration is free and open to the public.

On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published a statement of policy intent for UK recognition of international regulatory approvals of certain medical devices (the “Statement”).  The Statement follows the Government response to the 2021 consultation on the future regulation of medical devices in the UK that details an intention to introduce alternative routes to market for medical devices, such as utilizing approvals from other countries and Medical Device Single Audit Program (“MDSAP”) certificates, in addition to the current UK Conformity Assessed (“UKCA”) marking process.

The MHRA has already taken similar steps in the medicines space, adopting a new International Recognition Procedure (“IRP”) in January 2024.

In relation to devices, the Statement applies to certain medical devices placed on the market in Great Britain.  For relevant devices, the MHRA proposes to recognize foreign approvals from regulators in Australia, Canada, EU/EEA and USA (which is a smaller number of acceptable regulators than under the MHRA’s IRP for medicines).  The Statement expressly excludes a number of medical devices from international recognition, including software as a medical device (“SaMD”) (including AI as a medical device (“AIaMD”)) and companion diagnostic products approved via US 510(k) (a route which relies on equivalence to a predicate).

The proposed framework is a draft and the final version is expected to come into force in 2025 at the same time as future core regulations.  It also remains the government’s intention to introduce transitional arrangements for UKCA marked devices at the same time.

Continue Reading UK MHRA Announces Intention To Recognize Certain International Approvals For Certain Medical Devices

On Friday, April 26, 2024, the Federal Trade Commission (“FTC”) voted 3-2 to issue a final rule (the “final rule”) that expands the scope of the Health Breach Notification Rule (“HBNR”) to apply to health apps and similar technologies and broadens what constitutes a breach of security, among other updates.  We previously covered the proposed rule, which was issued on May 18, 2023.

Continue Reading FTC Issues Final Rule to Expand Scope of the Health Breach Notification Rule

On April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence (“AI”).  The Approach is a response to the UK Government’s white paper: a pro-innovation approach to AI regulation and subsequent Secretary of State letter of 1 February 2024, and is the culmination of 12 months’ work by the MHRA to ensure the risks of AI are appropriately balanced with the potential transformative impact of AI in healthcare.

AI in Healthcare

AI has the potential to revolutionize the healthcare sector and improve health outcomes at every stage of healthcare provision – from preventative care through to diagnosis and treatment.  AI can help in research and development by strengthening outcomes of clinical trials, as well as being used to improve the clinical care of patients by personalizing care, improving diagnosis and treatment, enhancing the delivery of care and health system efficiency, and supplementing healthcare professionals’ knowledge, skills and competencies. 

Continue Reading MHRA Outlines New Strategic Approach to Artificial Intelligence

In March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  Although the text has not yet been formally adopted by all the European institutions, a number of interesting points can already be highlighted.  This article focuses on the governance and enforcement of the EHDS; for an overview of the EHDS generally, see our first post in this series.

The final text of the EHDS was adopted by the European Parliament on 24 April 2024 and is expected to be formally adopted by the European Council in the coming months.

Continue Reading EHDS Series – 5: European Health Data Space Governance, Enforcement and Timelines

On April 22, 2024, the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) issued a statement on the application of the AI Act in the medicinal product lifecycle. The EFPIA statement highlights that AI applications are likely to play an increasing role in the development and manufacture of medicines.  As drug development is already governed by a longstanding and detailed EU regulatory framework, EFPIA stresses that care should be taken to ensure that any rules on the use of AI are fit-for-purpose, adequately tailored, risk-based, and do not duplicate existing rules.  The statement sets forth five “considerations”:

Continue Reading EFPIA Issues Statement on Application of the AI Act in the Medicinal Product Lifecycle

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted. This article focuses on the implications for “wellness applications” and medical devices; for an overview of the EHDS generally, see our first post in this series.

The final text of the EHDS was adopted by the European Parliament on 24 April 2024 and is expected to be formally adopted by the European Council in the coming months.

Continue Reading EHDS Series – 4: The European Health Data Space’s Implications for “Wellness Applications” and Medical Devices

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.  This article focusses on the obligations of data users; for an overview of the EHDS generally, see our first post in this series.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.

Continue Reading EHDS Series – 3: The European Health Data Space from the Health Data User’s Perspective

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.  This article focusses on the obligations of data holders; for an overview of the EHDS generally, see our first post in this series.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.

Continue Reading EHDS Series – 2: The European Health Data Space from the Health Data Holder’s Perspective

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.

Continue Reading EHDS Series – 1: Five Key Take Aways on Secondary Use of Health Data