HIT Consultant

OCTOBER 21, 2024

What You Should Know: – Gesund.ai , the clinical AI validation company, today announced the open sourcing of a comprehensive library of evaluation methodologies and frameworks to help developers and users address AI performance and potential bias across patient cohorts for the FDA-regulated AI solutions on the market.

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Healthcare ECONOMIST

MAY 10, 2023

Today I’m turning this post over to some of my FTI colleagues in Europe ( Antoine Mialhe , Katja Murray and Valeria Fagone among others) who helped summarize the Reform of the EU pharmaceutical legislation that the European Union (EU) adopted on April 26, 2023. A more detailed analysis is in the PDF link below.

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Bill Of Health

APRIL 5, 2022

When we talk about microdosing psychedelics, it’s important we have a mutual understanding of its definition to be able to conduct accurate research, promote regulations, and educate the wider population. The post A Precise Definition of Microdosing Psychedelics is Needed to Promote Equitable Regulation appeared first on Bill of Health.

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HIT Consultant

OCTOBER 31, 2024

Rather, pharmacy encompasses a myriad of angles in health care – the pharmaceutical commercialization process, benefits coverage and therapy tiering, drug cost management, distribution regulations – the list could go on and on. The idea of “pharmacy” isn’t just in the terms of where a patient picks up their medication. It’s pharmacy.

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Healthcare It News

JUNE 29, 2022

According to DHA director-general, Awadh Seghayer Al Ketbi, the authority is “implementing policies and regulations to further accelerate the development of the health sector,” with “patient centricity” as priority. ” WHY IT MATTERS.

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NASHP

OCTOBER 4, 2021

Pharmaceutical Care Management Association (PCMA) ?was The ruling affirmed that states can regulate pharmacy benefit managers (PBMs) despite PCMA’s assertion that?the?federal?Employee preempted such regulation.?The? PBM regulation is already the most common form of drug pricing-related legislation in state legislatures, and the?

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HIT Consultant

OCTOBER 25, 2022

The proportion of pharmaceutical companies hiring for AI-related positions kept relatively steady in May 2022 compared with the equivalent month last year, according to a Pharmaceutical Technology study, with 39.3% of the companies included in the analysis recruiting for at least one such position. . Operational Challenges of AI.

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HIT Consultant

APRIL 14, 2025

Medicine vs. Other Regulated Industries Finance and law are other highly regulated fields where AI is playing an increasingly important role. This is in contrast to other regulated domains like finance or law, perhaps because medicine is larger, more complex, and continuously evolving in a way that other domains are not.

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NASHP

MARCH 31, 2025

Highlights from the opinion include the following: The court found that Amgen did not effectively establish that the companys profits would be reduced, citing “counterintuitive pricing behavior” across the pharmaceutical supply chain and the inability to predict an upper payment limit.

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HIT Consultant

APRIL 21, 2025

With over three decades of experience per founder in phototherapy research, the team previously developed circadian-regulating light solutionsnow widely used for conditions such as seasonal affective disorder, sleep disturbances, anxiety, and depressionbefore their acquisition by Philips-Respironics in 2007.

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Bill Of Health

MARCH 13, 2025

In the EU, the Clinical Trials Regulation (CTR) enforces a structured and comprehensive transparency framework systematically publishing trial data through the Clinical Trials Information System (CTIS), with narrow, justified redactions permitted. Salix Pharmaceuticals v. Norwich and Vanda Pharmaceuticals Inc. In the U.S.,

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HIT Consultant

NOVEMBER 25, 2024

While part of that is attributable to the unique nature of drug development, versus other industries, and the enormous stakes at play if researchers, manufacturers and regulators fail to hit the mark, there are some lessons on innovation and efficiency that could be learned from other industries.

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Bill Of Health

FEBRUARY 18, 2025

Legal challenges and fragmented regulations are holding back the potential of personalized medicine. Sustainable Innovation: Ecosystems, Drug Regulation, and Data Infrastructure Sustainability in life sciences demands addressing environmental, social, and governance (ESG) challenges while navigating increasingly complex regulatory ecosystems.

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HIT Consultant

JANUARY 27, 2025

AI is revolutionizing pharmaceuticals and clinical research by significantly accelerating drug discovery and development. Clinicians, technologists, regulators, and policymakers must work together to develop ethical guidelines and robust regulatory frameworks that maximize AIs potential while safeguarding against unintended consequences.

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Bill Of Health

DECEMBER 11, 2024

Regulation of Dietary Supplements Popular nootropic brands like AlphaBRAIN and NooCube are sold in bottles which, at first look like any over-the-counter medication. For more information on the uniquely lax regulation of dietary supplements, read this Bill of Health article published a few years ago.

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Healthcare It News

JANUARY 30, 2024

Developers will need to keep in mind how an AI engine functions within local laws and regulations. Privacy will be one of the first major areas a company will need to tackle, followed by adapting to each different health system – direct to patients, hospital systems, pharmaceuticals – and, of course, patient rights.

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Sheppard Health Law

OCTOBER 25, 2023

and the City of Chicago, Illinois, in further regulating the activities of pharmaceutical representatives. The Act builds on Governor Lamont’s policy initiatives , which aim to improve the delivery of care and reduce healthcare costs for Connecticut residents and includes the initiative to regulate pharmaceutical marketing practices.

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Bill Of Health

OCTOBER 17, 2024

California’s recent laws represent an emerging effort by states to regulate the use of artificial intelligence in health care. She is interested in mass torts, drug product liability, pharmaceutical antitrust, and the administrative law that affects health-related regulations promulgated by agencies. Rebekah Ninan’s (J.D.

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Bill Of Health

MARCH 14, 2025

Government Regulation Hims? Nor did the ad list any of the side effects or contraindications of the drug, as prescription drug companies are required to do by FDA regulation. By Erin Lynch Government Regulation Mind over Machine: Navigating the Legal and Ethical Frontier of Neurotech By Erin Lynch The post Hims?

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Healthcare ECONOMIST

JANUARY 27, 2025

One point they make is that the IRA’s Medicare Drug Price Negotiation program will reduce pharmaceutical expenses on marketing and lobbying. While it is true that lobbying may be less impactful, complying with government regulations around IRA document submission is likely to increase drug manufacturers administrative cost.

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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. Multinational pharmaceutical companies have declined collaboration with C-TAP and with the WHO mRNA hubs on COVID-19 vaccines. By Ellen ‘t Hoen.

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HIT Consultant

JANUARY 9, 2025

The transition isnt happening overnight, but such incremental approaches are necessary to ensure success in such a highly regulated environment. But open source comes with its own set of challengesespecially for such a tightly regulated industry. For decades, SAS was it in life sciences.

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Home Health Care

NOVEMBER 22, 2024

It’s very over regulated, and that’s something you typically don’t see on a lot of other aspects of health care. I don’t need massive health systems lobbying with pharmaceutical companies to drive up prices just so they can hit certain numbers. I need the cost, in general, to be as low as possible.

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Bill Of Health

OCTOBER 28, 2022

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues. Holding Pharmaceutical and Medical Device Executives Accountable as Responsible Corporate Officers.

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Bill Of Health

SEPTEMBER 24, 2021

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues. FDA Regulation and Approval of Medical Devices: 1976-2020. Kesselheim. Value Health. Epub 2021 Aug 8.

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Bill Of Health

JANUARY 20, 2022

This is the failure to regulate our hospitals holistically, as part of a comprehensive health care system. Existing health care regulation focuses almost exclusively on regulating individual components of the health care industry.

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Bill Of Health

NOVEMBER 4, 2024

Food and Drug Administration (FDA) regulates tampons and menstrual cups as Class II medical devices. Menstrual pads are Class I medical devices and therefore are even less regulated by the agency. PetStates have stepped in to fill the gaps in federal regulation. California and Nevada have similar laws.

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HIT Consultant

JULY 10, 2024

Enhanced Efficiency and Regulatory Compliance The new features prioritize efficiency and regulatory compliance, streamlining workflows for pharmaceutical and medical device companies, as well as clinical research organizations (CROs). This eliminates manual data entry, saving significant time and resources.

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Bill Of Health

APRIL 7, 2022

We are excited to welcome our inaugural group of affiliated researchers for the Project on Psychedelics Law and Regulation (POPLAR). His teaching and research interests are in the areas of intellectual property, privacy, and the regulation of controlled substances. Dustin Marlan , J.D.

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Bill Of Health

AUGUST 6, 2021

However, since each disease affects less than one person in every 2,000, the pharmaceutical industry has traditionally been reluctant to invest in research and development connected to such illnesses given the small market. Orphan Drug Act 1983 and the EU Orphan Drug Regulation 2000) were enacted in an effort to incentivize innovation.

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HIT Consultant

JUNE 26, 2024

In 2022, the FDA released draft guidance outlining strategies for pharmaceutical companies to improve participation from underrepresented racial and ethnic groups in clinical trials. As the FDA finalizes these guidelines, pharmaceutical companies are expected to continue prioritizing investments in diversity initiatives.

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HIT Consultant

FEBRUARY 8, 2024

– Unlearn collaborates with pharmaceutical companies, biotechs, and academic institutions to optimize and streamline clinical trials. This investment, bringing Unlearn’s total funding to over $130M, will fuel its mission to eliminate trial and error in medicine through faster, smaller, and more ethical clinical trials.

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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. This procedure was adopted in 2001, and includes new treatments that are outside of the CP such as other pharmaceuticals and generics. Centralized procedure (CP).

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HIT Consultant

JULY 25, 2022

Lauren Ohlsson, Lead of Industry Solutions, Pharmaceutical and Healthcare, at VDX.tv. Consumers continue to cut ties with traditional TV and cable services, prompting industries like the prescription pharmaceutical industry to evolve their marketing mix to accommodate emerging media. . About Lauren Ohlsson.

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HIT Consultant

SEPTEMBER 8, 2022

. – The combination of Ypsomed’s devices with Sidekick’s digital health, behavioural economics and gamification expertise will form a unique solution delivering an engaging and personalized patient experience to people with chronic conditions, as well as a turn-key, best-in-class digital therapy management system for pharmaceutical customers.

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HIT Consultant

JANUARY 11, 2024

Supply Chains on Steroids: From tracking pharmaceuticals to verifying medical equipment authenticity, blockchain brings transparency and traceability to healthcare supply chains, combating counterfeiting and ensuring patient safety.

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HIT Consultant

AUGUST 16, 2023

Accelerating the Adoption of IDMP-O to Simplify and Standardise data Assets “Fluree is a perfect fit for pharmaceutical organizations seeking to balance regulatory compliance with innovation and accelerate drug discovery, efficacy and efficiency,” said Eliud Polanco, Fluree president. years, with only a 7.9% years, with only a 7.9%

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