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

Bill Of Health

MAY 20, 2024

This includes addressing potential specific AI-related risks—such as biases, discrimination, and data poisoning—as well as ensuring data security and privacy, and delineating liability for failures or harm caused by these technologies. The legal landscape regarding the applicability of liability law to AI is evolving rapidly.

Regulations 44

Regulations Healthcare Biotechnology Accountability 44

Bill Of Health

JUNE 18, 2024

Those good intentions notwithstanding, the current health data landscape is dramatically different from when the organizational author of the plan, the Office of the National Coordinator for Health IT, formed two decades ago.

Doctors 70

Doctors Accountability Regulations Health Data 70