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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.

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Insured, Sick and Broke – The Latest on the State of U.S. Health-Insured Consumers’ Financial Health

Health Populi

This is what rationing health care looks like in America: one in two people in families dealing with a chronic health condition have difficulty affording paying medial bills before meeting a deductible, unexpected medical bills, co-payments for prescription drugs, co-payments for physician visits, and/or their monthly health insurance premium.

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CVS Health in Talks to Acquire Signify Health

HIT Consultant

Wall Street has largely focused on CVS’s efforts to add primary-care practices and doctors to its payroll, though executives have also discussed their ambitions to expand its in-home health presence. Signify uses analytics and technology to help health plans, employers, physician groups and health systems with in-home care.

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Only in America: The Loss of Health Insurance as a Toxic Financial Side Effect of the COVID-19 Pandemic

Health Populi

Census Bureau found that the level of health insurance enrollment fell by 1 million people in 2019 , with about 30 million Americans not covered by health insurance. million people in 2017. The coronavirus pandemic has only exacerbated the erosion of the health insured population.

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Data Breaches Reported by New Jersey Brain and Spine, Highmark Inc. and Dialyze Direct

HIPAA Journal

Webb Mason provided patient data to Quantum Group in 2017 to assist with marketing efforts for Highmark, and that information has potentially been accessed by unauthorized individuals. Highmark Inc., Highmark stressed that its own IT systems were not compromised. Notification letters have been sent to affected patients.

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Consumer Health and Patient Engagement – Are We There Yet?

Health Populi

The report analyzes results of a survey of over 2,000 Change Healthcare customers (from academia, government, technology vendors, hospitals, providers, and health plans), conducted in October-November 2017. Remember that health insurers rank very low on consumer experience compared with retailers and grocers.

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A Brief Quantum Medicine Policy Guide

Bill of Health

Devices must primarily comply with Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostic Medical Devices. The EU AI Act , proposed EU AI Liability Directive , and laws under the European Strategy for Data , such as the Data Governance Act , may also play roles. The regulatory landscape in the U.S.

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