On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations ("Draft Guidance"). This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides information on FDA's expectations for the use of Electronic Health Record ("EHR") data to clinical investigators, research institutions and sponsors of clinical research on drugs, biologics, medical devices and combination products conducted under an ...
The Physician Payment Sunshine Act, which was incorporated into Section 6002 of the Affordable Care Act, requires pharmaceutical, medical device, biological and medical supply manufacturers to file annual reports on payments to physicians and teaching hospitals. Despite the requirement in the law that manufacturers submit their first report in March 2013 disclosing payments made during 2012, two events have pushed back that obligation or taken the sting out of noncompliance.
First, although Centers for Medicare & Medicaid Services (CMS) was required to publish standards for ...
Blog Editors
Recent Updates
- At Long Last, DEA’s Remote Prescribing Rules 2.0 Are (Really) Here! (Pending Further Consideration by the Incoming Administration . . .)
- Massachusetts District Court Applies “But-For Causation” Standard, Dismisses AKS-Based FCA Case After Evaluating Facts and Circumstances of Independent Contractor Arrangements
- DOJ’s False Claims Act Recoveries Top $2.9 Billion in FY 2024, but Health Care Numbers Dip—What Could FY 2025 Hold for Health Care Enforcement?
- Recent Developments in Health Care Cybersecurity and Oversight: 2024 Wrap Up and 2025 Outlook
- Massachusetts Governor Maura Healey Signs into Law a Sweeping Health Care Market Oversight Bill