On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations ("Draft Guidance"). This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides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 ...
Recent Updates
- DOJ, HHS Announce One-Stop Shop for Companies Voluntarily Disclosing Potential Health Care Fraud
- DOJ, HHS, CMS Launch an FCA Self-Disclosure Program for Health Care: Who Can Participate, How, and Why
- Psychedelics Move Toward the Mainstream: Lawyers’ Bird’s-Eye View from the Horizons Conference
- CMS Receives Its Exclusion Authority: What Happens Now?
- GLOBE Model Final Rule Drops — but Will It Work on a Smaller Scale?