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EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill of Health

Beyond the health care sector-specific Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), this mix of AI & Data related regulatory requirements stems from a series of generalized, cross-sectoral EU laws of the last 5 years. The sectorialism of the U.S.

FDA 282
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SQA Regulatory Surveillance Summary 4 | Monthly Update 2021

SQA

183/2017, which provides the procedures to obtain the Brazilian Good Manufacturing Practices (BGMP) Certification for medical devices. Health Canada – Biologics. Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021.

FDA 52
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A Health-Heavy State of the Union

Kaiser Health News

Biden’s calls for bipartisanship to extend health programs like pandemic-era subsidies for Affordable Care Act health plans are expected to clash with conservative demands to slash federal government spending. But first, this week’s health news.

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Here are the major issues facing healthcare in 2021, according to PwC

Healthcare IT News - Telehealth

The virtual trial, to be sure, is not a new concept: One team of researchers counted more than 1,100 trials listed on ClinicalTrials.gov employing connected digital products for remote data collection in both 2017 and 2018, the organization observed. ” The FDA is hinting that some of these changes could be here to stay.

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GOP House Opens With Abortion Agenda

Kaiser Health News

On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. The FDA puts these extra restrictions or safeguards in place for certain drugs to add additional protection. Some advocates say these pills simply do not bring that level or risk.

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Consumers Expand Their Definition of Well-Being to Include Food-As-Medicine

Health Populi

Consumers point to some organizations that they perceive may be working against their better health: these include fast food manufacturers, the entertainment industry, food processors (“Big Food”), the media, government agencies, and health insurance companies.

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Hall Render’s Health Provider News – January 28, 2022

Hall Render

FDA halts use of antibody drugs that don’t work vs. omicron. FDA finalizes two guidances on including patient perspectives in medtech clinical trials. State health officer discusses Alabama’s COVID-19 peak. Florida health officials face hurdles with limited supply of monoclonal antibody from government.