Archive for December, 2021

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Changes to Stark Law Special Compensation Rules for Group Practices Go into Effect on January 1, 2022

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 and distribution of profits for the provision designated health services (“DHS”)….

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Reality Check: FDA Draft Guidance Outlines Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological Products

Last week the FDA issued another draft guidance in its series of recent guidance documents setting forth the agency’s views regarding the generation and use of Real-World Data (RWD) and Real-World Evidence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 (see our recent post on FDA’s draft guidance relating to registries)….

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3 Key Considerations for Promoting Transparency for AI/ML-Enabled Medical Devices

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 degree to which information about such devices is communicated to…

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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 who: knowingly provide deficient cybersecurity products or services, knowingly misrepresenting…

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It’s Starting to Register: FDA Draft Guidance Addresses Use of Registries to Support Regulatory Decision-Making for Drugs & Biological Products

Showing no signs of food coma, the FDA issued draft guidance on the Monday following the Thanksgiving holiday weekend that outlines considerations for sponsors proposing to design a registry or use an existing registry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 drug’s effectiveness or safety.  This draft guidance represents the Agency’s…

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