Bill Of Health

OCTOBER 27, 2023

Namely, legal protections concerning personal health data may not apply when the entity offering the service is decidedly not a “provider.” To illustrate the issue, consider that the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) expressly covers genetic information as a form of health data.

Biotechnology 62

Biotechnology Regulations Medical Services Health Data 62

Bill Of Health

AUGUST 18, 2021

Direct-to-consumer (DTC) health apps, such as apps that manage our diet, fitness, and sleep, are becoming ubiquitous in our digital world. These apps provide a window into some of the key issues in the world of digital health — including data privacy, data access, data ownership, bias, and the regulation of health technology.

Biotechnology 98

Biotechnology Regulations Accountability Health Data 98

Bill Of Health

APRIL 4, 2024

Cross-sectoral EU laws First and foremost, the product as a whole must comply with the Medical Device Regulation (MDR) and the specific norms incorporated therein, as well as with GDPR requirements and ESG considerations, just to name a few. AI regulation has, for the most part, been sectoral rather than cross-sectoral.

Regulations 113

Regulations Accountability Health Data Patient Safety 113

Bill Of Health

NOVEMBER 17, 2023

By Adithi Iyer Last month, President Biden signed an Executive Order mobilizing an all-hands-on-deck approach to the cross-sector regulation of artificial intelligence (AI). One such sector (mentioned, from my search, 33 times) is health/care. But it is certainly eye-catching to see biological security risks join the list.

Biotechnology 99

Biotechnology Regulations Patient Safety Health Data 99