Podcast - Regulating AI in Healthcare: The Road Ahead
Wild Times for the Community Reinvestment Act
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Understanding BBB Ratings: Building Trust and Mitigating Risks — Regulatory Oversight Podcast
Top challenges with Compliance Management
Solicitors General Insights: The Tale of Two Washingtons — Regulatory Oversight Podcast
The Capital Ratio Podcast | Entering the US Banking Market
Compliance Tip of the Day: COSO Objective 3 – Control Activities
Solicitors General Insights: The Legal Frontlines in Iowa and Indiana — Regulatory Oversight Podcast
Cannabis Law Now Podcast - Cannabis in the Show Me State: An Interview with BeLeaf Medical's Mitch Meyers
2 Gurus Talk Compliance – Episode 54 – The FCPA is Back On Edition
Compliance Tip of the Day: Board Oversight on Internal Controls
Healthcare Enterprise Risk Management
Understanding MALPB Charters: A Collaborative Approach to Banking Innovation — Payments Pros – The Payments Law Podcast
State AGs Unite: New Privacy Task Force Signals Shift in Regulatory Power Dynamics — Regulatory Oversight Podcast
The fatal flaws in the 2023 CRA rule
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
State AGs Unite: New Privacy Task Force Signals Shift in Regulatory Power Dynamics — The Consumer Finance Podcast
From Cell Phones to Tractors: The Right to Repair Movement Drives On — Regulatory Oversight Podcast
AI Legislation: The Statewide Spotlight - Regulatory Oversight Podcast
Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more
As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early...more
The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and...more
The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions. Recently,...more
Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and treatment of diseases, conditions, and infections. Examples of LDTs are the COVID-19...more
Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for sponsors, investigators, and...more
Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more
For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug,...more
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update on the timing of the reform of the current UK legislation, the Medical Device Regulations 2002 (UK MDR), and the transitional arrangements...more
On 23 March 2023 the new Spanish Medical Devices Regulation (Spanish MDR) came into force. After a lengthy wait, the medical devices industry (and any other interested sector) finally has access to the final text and knows...more
While waiting for a new governance to make the process of selecting and purchasing medical devices more efficient, thus incentivizing investment in innovative technologies, the activation of the payback mechanism may...more
The United Kingdom medical devices regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has announced that the upcoming changes to UK medical device legislation will be pushed back from 1 July 2023 to 1...more
On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention: - To extend the current standstill period by twelve months from...more
The U.S. Food and Drug Administration (“FDA” or the “Agency”) has issued a final report discussing the results of its Software Precertification Pilot Program (the “Pilot Program”). Importantly, the September 26, 2022 report...more
In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device...more
In recent years we have seen more and more gene and cell therapies coming successfully to market – but many more such candidates have not made it to market, or been unable to obtain sufficient reimbursement. Gene and cell...more
In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more
The agency’s consultation on the post-Brexit regulatory framework for medical devices and diagnostics aims to support innovation and sustainability, among other goals. A 10-week consultation launched by the UK’s Medicines...more
Amy Dow and Brad Thompson, Members of the Firm, speak on “Shaping the Future of Artificial Intelligence (AI) Within Life Sciences,” a virtual program co-hosted by Simmons & Simmons and Epstein Becker Green. On both sides of...more
The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more
What This Means for the FDA and the Industry - The COVID-19 pandemic has spurred the development of digital health products utilizing artificial intelligence (AI) and machine learning (ML). When the pandemic passes, there...more
The Spanish Ministry of Health has initiated the hearing and public information process for the new regulation on medical devices. The draft text will be available for contributions by 10 July 2021. The direct application of...more