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Public Health Product Hops

Bill of Health

Regulatory and patent exclusivity periods govern the timing of generic entry, and because market share and revenue is often quickly lost upon market entry of generic drugs, extending market exclusivity for any duration can be extremely profitable. But perhaps other forms of public health benefit would outweigh these harms?

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Illinois Opioid Prescribing and Opioid Abuse Training for Dental Healthcare Providers

American Medical Compliance

The Opioid Epidemic As of October 16, 2017, the US government officially declared the opioid epidemic a public health emergency. For dental healthcare providers, this public health emergency signifies a critical need to be vigilant and proactive in opioid prescribing practices.

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AI’s Ability to Manipulate Decision Making Requires a Moratorium on Its Use in Obtaining Consent for Biomedical Research

Bill of Health

The federal government’s commitment to assuring that participants in human subject research provide fully informed consent dates back to the U.S In 2017, Congress acted again to update the Common Rule and strengthen the provisions related to consent. While the U.S.

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Health Privacy and Our Ambivalent Tech-Embrace – Lessons for Digital Health Innovators

Health Populi

Even so, 2 in 3 adults said they would likely get an app to track a medical condition that was approved by the FDA. At the same time, 2 in 3 people were also concerned aobut the privacy of their health information on apps. And there’s the ambivalence of “concerned embrace” of digital health.

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How the Medical Industry Can Help Combat the Current Coronavirus Crisis

Exeed Regulatory Compliance

Travel is being restricted, large scale public events are likely to be cancelled, and schools and businesses may be closed to contain the spread of the virus. Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. There is now an FDA policy released on 29 Feb.

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Industry Groups Provide Feedback on Sen. Warner’s ‘Cybersecurity is Patient Safety’ White Paper

HIPAA Journal

The AHA said “hospitals and health systems have prioritized protecting patients and defending their networks from cyberattacks. However, they need support from the federal government as the field continues to face targets from sophisticated cyber adversaries and nation-states.”.

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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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