The final rules regarding special compensation under 42 U.S.C. § 1395nn, the Physician Self-Referral or Stark Law, go into effect on January 1, 2022 and will require many physician group practices to modify their compensation methodologies, specifically the pooling
Life Sciences Perspectives
Life Sciences Perspectives, published by Goodwin Procter, focuses on legal and regulatory developments affecting the life sciences sector. The blog covers topics such as pharmaceutical and biotechnology transactions, regulatory compliance for drugs, biologics, medical devices, diagnostics, and laboratory testing. It also addresses antitrust issues, healthcare fraud enforcement, data privacy regulations like the EU Data Act, and FDA programs impacting drug development and approval. The blog provides updates on policy changes, enforcement trends, and strategic considerations for companies and investors operating in the life sciences and medtech industries.
Latest from Life Sciences Perspectives - Page 17
Reality Check: FDA Draft Guidance Outlines Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological Products
Last week the FDA issued another draft guidance in its series of recent guidance documents setting forth the agency’s views regarding the generation and use of Real-World Data (RWD) and Real-World Evidence (RWE) for prescription drugs and biological products. (see…
3 Key Considerations for Promoting Transparency for AI/ML-Enabled Medical Devices
By Steven Tjoe
Today, developers of innovative medical devices are increasingly utilizing artificial intelligence (AI) and machine learning (ML) technologies to derive important insights with the promise of transforming the delivery of healthcare. Yet, concerns regarding the transparency of AI/ML-enabled devices, or the…
DOJ Announces New Initiative to Use False Claims Act to Enforce Compliance with Data Privacy and Security Laws and Contract Requirements
The Department of Justice recently announced the launch of its new Civil Cyber-Fraud Initiative (the “Initiative”) which intends to use the False Claims Act to pursue “cybersecurity-related fraud by government contractors and grant recipients.”
Specifically, the Initiative will target those…
It’s Starting to Register: FDA Draft Guidance Addresses Use of Registries to Support Regulatory Decision-Making for Drugs & Biological Products
Showing no signs of food coma, the FDA issued draft guidance on the Monday following the Thanksgiving holiday weekend that outlines considerations for sponsors proposing to design a registry or use an existing registry to support regulatory decision-making about a…
Things for Pharma and Biotech Companies to Watch in the Cures 2.0 Proposed Legislation
Last week, Diana DeGette (D-CO) and Fred Upton (R-MI) introduced in the House highly anticipated bill language for “Cures 2.0”, a follow-up to the transformational 21st Century Cures Act enacted in 2016. For full text of the bill, click here…
Senate Judiciary Committee Advances False Claims Act Amendment to Full Senate
By Publisher
On October 28, a majority of members on the Senate Judiciary Committee voted 15-7 to advance to the full Senate a bipartisan bill that would make a number of amendments to the False Claims Act (“FCA”), including one that would…
FDA Issues Guiding Principles for Good Machine Learning Practice for Medical Device Development
On October 27, 2021, the U.S. Food and Drug Administration (FDA), Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a set of ten guiding principles meant to aid the development of Good Machine Learning…
OIG Advocates for Increased Oversight of Medicaid Telehealth Services in Behavioral Health
Telehealth’s exponential growth –in part due to the COVID-19 pandemic – has highlighted both its value in increasing access to care and the potential for misuse. The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) released…
Goodwin Webinar Series: Life Sciences Disputes
Goodwin is pleased to invite you to our Life Sciences Disputes webinar series, which will highlight current topics across our Securities Litigation and Antitrust practice areas that affect life sciences companies.
Trends and Hot Topics in Securities Litigation and…