Morning Headlines 4/29/19
Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties
HHS announces that it will use its discretion to set maximum annual HIPAA fines based on level of culpability, reducing the amount for those with no knowledge from $1.5 million to $25,000.
uBiome, the health start-up just raided by the FBI, had been double billing insurers
The FBI raids the San Francisco office of UBiome, which sells questionably useful AI-powered microbiome test kits for gut health and women’s health that are ordered by its own telemedicine doctors.
The future of health to have new home
Arizona State University and Mayo Clinic break ground in Phoenix on the Health Futures center, which will house a medical technology accelerator, research labs for biomedical engineering and informatics, and nursing programs.
Tech Billionaires Give $200 Million to Mass. General Hospital
InterSystems founder Terry Ragon and his wife Susan donate $200 million to Massachusetts General Hospital to endow a vaccine research center, piggybacking onto their $100 million donation 10 years ago to fund AIDS vaccine research.
FDA guidance regarding SaMD is confusing and a distinction without a difference. Either just bite the bullet and classify all…