In keeping with — and in response to — HHS-OIG’s November 2020 Special Fraud Alert on industry speaker programs, the Pharmaceutical Research and Manufacturers of America has updated its Code on Interactions with Health Care...more
In its November 16, 2020, Special Fraud Alert, the HHS Office of Inspector General drew attention to potential fraud and abuse risks of speaker programs hosted by pharmaceutical companies and medical device manufacturers....more
11/18/2020
/ AdvaMed ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health Care Providers ,
Healthcare Fraud ,
Inspector General ,
Manufacturing Facilities ,
Medical Devices ,
New Guidance ,
OIG ,
Pharmaceutical Industry ,
PHRMA ,
Risk Factors ,
Speaker Programs
The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more
1/14/2020
/ 21st Century Cures Act ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Drug Pricing ,
FDA Commissioner ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Oversight
In its first update in a decade and effective January 1, 2020, the revised Advanced Medical Technology Association (AdvaMed) Code of Ethics in Interactions with Health Care Professionals (Code) in the United States contains...more
Introduction -
Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more
1/10/2018
/ 21st Century Cures Act ,
Artificial Intelligence ,
Biometric Information ,
Consumer Protection Act ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Health Insurance ,
Life Sciences ,
OIG ,
Privacy Policy ,
Research and Development ,
TCPA ,
Telehealth
The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more
On August 2, 2016, the US Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) jointly issued draft guidance concerning Institutional Review Board (IRB) written procedures. The guidance...more