Bill Of Health

OCTOBER 17, 2023

While the Moderna-Merck intervention classifies as a regulated drug or therapy, it is not a stretch of the imagination to map this type of dynamic onto a non-therapeutic service offering like 23andMe. It seems, in the near term, that the “who” would probably be a venture-backed biotechnology company — a corporate actor.

Biotechnology 113

Biotechnology Regulations Medical Technology 113

Bill Of Health

FEBRUARY 5, 2025

This tension exists within the current regulatory structure: Consumers fear their food supply is poisoning them, while regulators feel limited in their ability to use modern toxicological standards to evaluate actual safety. The Regulatory Framework for Food and Color Additives FDA regulates the U.S.

Biotechnology 52

Biotechnology Regulations Health Science 52

HIT Consultant

DECEMBER 7, 2023

What You Should Know: Insilico Medicine (“Insilico”) , a generative artificial intelligence (AI)-driven clinical-stage biotechnology company, today announced that the company has initiated the first-in-human study for ISM5411, a potentially first-in-class PHD inhibitor for the treatment of inflammatory bowel disease (IBD).

Biotechnology 98

Biotechnology Regulations 98

Bill Of Health

JUNE 16, 2023

Panelists discussed these topics during a recent webinar hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. By Minsoo Kwon The legalization of cannabis has raised ethical, regulatory, and scientific questions. This article highlights key points made during the conversation.

Biotechnology 105

Biotechnology Regulations Hospitals 105

Bill Of Health

OCTOBER 28, 2024

The Petrie-Flom Center is excited to announce our affiliated researchers for the Project on Psychedelics Law and Regulation (POPLAR) and our new project , Psychedelic Use, Law, and Spiritual Experience (PULSE). she/they) has been contributing to the interdisciplinary field of Psychedelic Studies since 2010. Callie Hoffmann , J.D.,

Regulations 45

Regulations Biotechnology Law Firms Hospitals 45

Bill Of Health

MAY 20, 2024

The EU AI Act: A Blueprint for Safe AI Systems The EU’s AI Act , enacted in March 2024, sets a new benchmark for AI regulation with a risk-based classification system—ranging from unacceptable to minimal risk—that dictates stringent safety measures and upholds fundamental rights.

Regulations 45

Regulations Healthcare Biotechnology Accountability 45

Bill Of Health

JANUARY 29, 2024

Dr. Devenot is also an affiliated researcher with Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Neşe Devenot, PhD is a Senior Lecturer in the University Writing Program at the Johns Hopkins University.

Biotechnology 142

Biotechnology Regulations Prevention Doctors 142

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 115

Regulations Accountability Health Data Patient Safety 115

Bill Of Health

AUGUST 18, 2021

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. Direct-to-consumer (DTC) health apps, such as apps that manage our diet, fitness, and sleep, are becoming ubiquitous in our digital world.

Biotechnology 98

Biotechnology Regulations Accountability Health Data 98

Bill Of Health

FEBRUARY 18, 2025

It provides tailored legal and regulatory support to patients, researchers, businesses, and incubators, driving progress in healthcare and biotechnology. Legal challenges and fragmented regulations are holding back the potential of personalized medicine. In Nature Medicine , we recently explored practical technical and legal solutions.

Life Sciences 52

Life Sciences Biotechnology Regulations Healthcare 52

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.

Regulations 105

Regulations Accountability Biotechnology Pharmaceuticals 105

Healthcare ECONOMIST

APRIL 8, 2024

If the EMA evaluates a pharmaceutical and grants it marketing authorization, this determination is binding all all European Union member states. cell and gene-therapy) also in 2008.

Pharmaceuticals 98

Pharmaceuticals Biotechnology Regulations 98

Bill Of Health

OCTOBER 27, 2023

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. Turning to the FTC? It may, in some cases, be the primary defender of patient privacy rights in biomatter and resultant data because it covers corporate entities.

Biotechnology 64

Biotechnology Regulations Medical Services Health Data 64

Bill Of Health

JANUARY 18, 2024

She emphasizes the importance of Principle 5 , pertaining to “human rights duties relating to non-State actors,” thereby focusing more on State regulation of private actors than State coordination and cooperation with private actors.

Regulations 108

Regulations Prevention Accountability Pharmaceuticals 108

Bill Of Health

SEPTEMBER 21, 2021

These six students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join us from across Harvard. 2022) with research interests that include bioethics and national security, human enhancement, and the regulation of food, supplements, and exercise. Jack Becker is a law student (J.D.

Biotechnology 59

Biotechnology Regulations Pharmaceuticals Doctors 59

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.

Biotechnology 52

Biotechnology Regulations Accountability Doctors 52

Bill Of Health

AUGUST 29, 2022

IBM and Google) to biotechnology (e.g., As noted above, the Open COVID Pledge , as well as vaccine availability programs by Pfizer, Merck and others , are all tied to the WHO’s determination of pandemic status, as are the commitments of the 196 countries bound by the WHO’s International Health Regulations.

Biotechnology 145

Biotechnology Prevention Pharmaceuticals Regulations 145

Bill Of Health

MARCH 1, 2024

Dr. Devenot is also an affiliated researcher with Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Neşe Devenot, PhD is a Senior Lecturer in the University Writing Program at the Johns Hopkins University.

Accountability 108

Accountability Biotechnology Rehabilitation Regulations 108

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.

Regulations 52

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.

Biotechnology 88

Biotechnology Regulations Prevention Accountability 88

Bill Of Health

APRIL 19, 2023

Panelists discussed these topics during a recent webinar hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. She discussed additional relevant neuroscience concepts, such as structural changes in gray matter and cortical thickness, and changes in personality and self-regulation.

Biotechnology 59

Biotechnology Rehabilitation Prevention Regulations 59

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. health data). If so, how?

Health Data 52

Health Data Regulations Biotechnology Pharmaceuticals 52

Bill Of Health

OCTOBER 15, 2021

The COVID-19 pandemic has laid bare the lack of regulation for the sharing of intellectual property (IP) and technology needed for an effective and equitable response to the crisis. The COVID-19 pandemic demonstrates that it is difficult to regulate the open sharing of IP/know-how and technology while a global health emergency is unfolding.

Pharmaceuticals 130

Pharmaceuticals Quality Assurance Health Technology Regulations 130

Bill Of Health

JANUARY 23, 2023

Individual countries and laboratories have instituted preventive self-regulation , however these vary country-by-country. Taiwan has engaged with international partners to perform “Joint External Evaluations” and developed national legislature for regulating high containment laboratories. Other countries have not been as diligent.

Prevention 116

Prevention Regulations Biotechnology 116

Bill Of Health

SEPTEMBER 22, 2022

These five students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join us from across Harvard. She has previously published articles on synthetic biology regulation and governance, end stage renal disease payment reform, and comparative analyses of learning disorder policy.

Biotechnology 52

Biotechnology Pharmaceuticals Medical Technology Regulations 52

Bill Of Health

DECEMBER 8, 2023

It did not introduce unprecedented enablement principles, and, in practice, biotechnology genus claims, including antibody claims, were already limited. The other possibility is that Amgen will only affect the patentability of antibodies, which long received more lenient treatment than other biotechnologies.

Biotechnology 52

Biotechnology Life Sciences Pharmaceuticals Regulations 52

Bill Of Health

NOVEMBER 7, 2024

South Africa’s Protection of Personal Information Act ( POPIA ), which predates the General Data Protection Regulation ( GDPR ) in Europe but shares similar values, provides strong privacy protections. One of the major legal challenges is balancing participants’ privacy rights with the need to make genomic data available for research.

Regulations 45

Regulations Healthcare Biotechnology 45

Health Advances

SEPTEMBER 15, 2020

Investors in Hong Kong who are closer to China can better understand the equity story of Chinese biotechnology companies. HKEX looks forward to continue working closely with Mainland exchanges and regulators to create more effective and efficient fundraising opportunities for biotech companies, such as A+H and Red chip+STAR board listings.”.

Pharmaceuticals 98

Pharmaceuticals Biotechnology Life Sciences Healthcare 98

Bill Of Health

OCTOBER 1, 2022

Since countries have sovereign rights over their biological resources , Indian companies enjoy easier access to and use of these biological resources for various commercial applications, including pharmaceuticals, cosmetics, and biotechnology. ” In other words, foreign investment up to at least 49% (less than majority) is encouraged.

Pharmaceuticals 52

Pharmaceuticals Biotechnology Regulations 52

Bill Of Health

DECEMBER 20, 2023

AbbVie’s position is representative: “Genus claims with functional limitations promote the progress of science…[they] are especially important in chemistry, pharmaceuticals, and biotechnology, where breakthrough innovations invariably require very significant investments of time and money.” The Alliance of U.S.

Pharmaceuticals 64

Pharmaceuticals Biotechnology Prevention Regulations 64

Bill Of Health

SEPTEMBER 16, 2024

She is interested in mass torts, drug product liability, pharmaceutical antitrust, and the administrative law that affects health-related regulations promulgated by agencies. Her research interests include genetics, environmental health sciences, novel biotechnologies, and the FDA regulatory process. Rebekah Ninan’s (J.D.

Biotechnology 40

Biotechnology Pharmaceuticals Health Science Medical Technology 40

Bill Of Health

JANUARY 7, 2022

The legal and institutional regime aimed at preventing and controlling the spread of infectious diseases, grounded on the International Health Regulations (IHR) was heavily criticized. The COVID-19 pandemic has raised unprecedented challenges for the global health framework and its long-term consequences are not yet in full sight.

Biotechnology 59

Biotechnology Prevention Regulations 59

American College of Healthcare Sciences

NOVEMBER 18, 2021

CFR – code of federal regulations 21. Electronic Code of Federal Regulations. 9] Electronic Code of Federal Regulation. Medicinal and Aromatic Plant Science and Biotechnology, 3(1):90-93. [16] Electronic Code of Federal Regulation. Electronic Code of Federal Regulation. 17(Suppl), 1979. [2] 17] [link].

Regulations 89

Regulations Biotechnology Healthcare Primary Care 89

Bill Of Health

JUNE 7, 2024

Additional gaps in research oversight may arise because portable MRI has the potential to empower citizen scientists and individuals engaged in do-it-yourself (DIY) research beyond the reach of the regulations requiring Institutional Review Board (IRB) oversight. fxshen@umn.edu Susan M.

Quality Control 85

Quality Control Data Acquisition Regulations Hospitals 85

Bill Of Health

JUNE 18, 2024

Whatever is in the record, the 21 st Century Cures Act and subsequent regulations addressing interoperability through mechanisms such as Fast Healthcare Interoperability Resources more commonly known as FHIR have made much of that information available for patients to access and share electronically with whomever they choose.

Doctors 87

Doctors Accountability Regulations Health Data 87

Bill Of Health

NOVEMBER 10, 2022

Balancing Regulation, Innovation and Ethics : Examining the challenges of balancing the competing concerns and trade-offs that arise in real-world settings, most obviously in hospitals and the physician-patient relations.

Medical Technology 85

Medical Technology Regulations Prevention Healthcare 85

Bill Of Health

APRIL 6, 2022

This delays the time before a generic drug or biosimilar can get approved, by blocking regulators from using the first applicant’s clinical data for the approval of competitors’ versions. Many countries provide a type of monopoly protection for new drug approvals called “ data exclusivity.”

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Pharmaceuticals Prevention Regulations Biotechnology 125