In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more
2/25/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Data Protection ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Regulatory Oversight ,
Telehealth ,
Telemedicine
The $2.5 million settlement reflects the agency’s focus on mobile health privacy.
On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a settlement with CardioNet, a...more
A flurry of regulatory activity preceded the transition in administration on January 20.
Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more
Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices.
On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more
The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity.
Recognizing the growing importance of cybersecurity for medical devices and the potential public...more