Bill Of Health

NOVEMBER 9, 2022

Food and Drug Administration became the agency it is today and how it makes some of its toughest decisions regarding the regulation of potent drugs. On the other hand, the FDA also serves as a gatekeeper to drugs and can unduly limit drug accessibility by regulating too zealously. Sekeres tells a captivating story of how the U.S.

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Regulations Accountability Biotechnology Pharmaceuticals 105

Bill Of Health

OCTOBER 27, 2023

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. The innovation-security tradeoff is a familiar trope in biotechnology, but the main character of the direct-to-consumer tissue-based service story is less so.

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Bill Of Health

DECEMBER 6, 2024

These technologies can act as privacy enhancing techniques (PET) to ensure privacy and compliance with regulations like HIPAA and GDPR. There is no specific regulation for quantum technology in healthcare, though the European Declaration on Quantum Technologies acknowledges its importance. The regulatory landscape in the U.S.

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Regulations Biotechnology Accountability Healthcare 52

Bill Of Health

OCTOBER 24, 2023

Despite more than a century-long existence, for instance, the World Health Organization’s (WHO’s) International Health Regulations only began to incorporate references to human rights in their text as recently as their 2005 iteration and even then engaged with the subject matter in broad strokes.

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Bill Of Health

APRIL 26, 2022

To navigate the myriad interests and stakes involved in creating federal psychedelic policy, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School convened a virtual panel discussion with three leading psychedelic policy advocates. By James R. A full video of the event is available below.

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Bill Of Health

JUNE 18, 2024

As Price and Cohen have pointed out, entities subject to federal Health Insurance Portability and Accountability Act (HIPAA) requirements represent just the tip of the informational iceberg. Collaborative health has three core principles: shared information, shared engagement, and shared accountability.

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Bill Of Health

APRIL 18, 2023

This sets the Convention apart from the EU’s AI Act, which focuses on regulating the development phase, and only stipulates strict rules for “high-risk” AI medical devices. It establishes these as enforceable rights — filling an often-criticized gap of other AI regulations.

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Regulations Doctors Accountability Biotechnology 59

Bill Of Health

JUNE 12, 2023

” Next Steps and Stakeholder Engagement In addition to soliciting feedback on the above-mentioned topics, the discussion paper notes that FDA is planning to host a workshop with stakeholders to provide an opportunity for further engagement.

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Pharmaceuticals Accountability Biotechnology Regulations 105

Bill Of Health

SEPTEMBER 15, 2023

The broad provisions appear to account for different circumstances. The Bill also introduces the right for employees, or agency workers post-qualifying period, in a “qualifying relationship with a person receiving fertility treatment” to take time off for appointments.

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Bill Of Health

APRIL 8, 2025

Federal and state regulators and governments have a role to play in shaping whether and how AI is used in the practice of medicine. Federal Regulation of AI as a Medical Device The U.S. Despite FDAs best thinking, it may prove challenging to regulate a moving target like AI. Most recently, on Jan.

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Regulations Biotechnology Health Science Medical Technology 52

Bill Of Health

APRIL 7, 2024

The FDA regulates food additives and “drugs and devices” but this latter designation is functionally split out into drugs, medical devices, and biologics (products derived from living sources). Notably, the GAO report was targeted at congressional committees to spur continued legislation and regulation in this space.

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Regulations Accountability Patient Experience Biotechnology 45

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). Some questions that are less than an eventuality: is now too soon for sweeping AI regulations?

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Biotechnology Regulations Patient Safety Health Data 100

Bill Of Health

FEBRUARY 21, 2024

However, the ends do not justify the means in this case; likening frozen embryos to children is not a legally sound mechanism to hold fertility clinics accountable for negligently storing embryos. Specifically, lawmaking in fertility care stands to fuel the movement to create fetal personhood rights and a federal abortion ban.

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Regulations Accountability Doctors Medicaid 103

Bill Of Health

JULY 28, 2022

We hosted a series of workshops with choice of law experts and research law and ethics experts to identify factors that are most crucial to account for in a future choice of law precision medicine research framework. Our experts identified factors that need to be accounted for in a future choice of law framework.

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