Bill Of Health
MARCH 23, 2023
By Enrique Santamaría Together with the Data Governance Act (DGA) and the General Data Protection Regulation (GDPR), the proposal for a Regulation on the European Health Data Space (EHDS) will most likely form the new regulatory and governance framework for the use of health data in the European Union.
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.
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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.
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.
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.
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.
Bill Of Health
JUNE 18, 2024
Millenson The latest draft government strategic plan for health information technology pledges to support health information sharing among individuals, health care providers and others “so that they can make informed decisions and create better health outcomes.”
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