In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more
9/18/2019
/ Cybersecurity ,
Digital Health ,
Federal Pilot Programs ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
PreCert Pilot Program ,
Precertification ,
Regulatory Oversight ,
Regulatory Requirements ,
Software ,
Software Developers ,
Voluntary Participation
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 enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more
2/10/2017
/ 510(k) RTA ,
Biologics ,
Clinical Trials ,
Cybersecurity ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
Laboratories ,
Medical Devices ,
Pharmacies ,
REMS ,
Software