C&M Health Law

NOVEMBER 3, 2022

Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). If this latest draft guidance is finalized after a period of public comment, the agency will incorporate the proposed language into the 2018 guidance.

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FDA Health Outcomes Public Health 52

HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. Health plans offering the OTC benefit can also leverage the opportunity to educate members about the significant role hearing aids can play in improving their overall health. – What new opportunities will arise? Introducing OTC hearing aids.

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Health Populi

MAY 29, 2018

Trust has become a key currency in provider/patient/supplier relationships: 94% of health executives say treating customers as partners is important to gain trust, according to the Digital Health Tech Vision 2018 from Accenture. Accenture’s vision this year is built on five pillars: Citizen AI. Extended Reality. Data Veracity.

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Fraud Health Outcomes FDA 90

Healthcare IT News - Telehealth

FEBRUARY 6, 2024

By using them, providers can enhance patient engagement, allowing for personalized and proactive care management that drives better health outcomes and better care experiences. Connected care at-home technologies enable behavior change and empower individuals and clinicians to make informed decisions about healthcare treatment.

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Nurses FDA Telemedicine Health Outcomes 163

HIT Consultant

OCTOBER 17, 2021

Since DTx plays such a substantive role in the therapeutic process, these apps must meet the same standards of clinical evidence required by the FDA and other regulatory agencies for approval of conventional medical treatments. FDA website, March 27, 2018. – The richness and size of the real-world datasets.

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FDA Health Outcomes Doctors Hospitals 98

Health Populi

AUGUST 2, 2022

When I talk about patient support programs (PSPs), I’m most often focused on supporting peoples’ access to medicines due to costs, bolstering health literacy, and addressing health citizens’ risks of drivers of health that can be obstacles to optimal health outcomes (those challenging social determinants of health).

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COVID-19 FDA Health Outcomes 62

HIT Consultant

DECEMBER 8, 2021

In fact, in January 2021, the FDA released an Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan, a clear indication of the technology’s explosive growth and legitimacy within healthcare. Zeynep Icten, Ph.D., Director of Data Science Solutions at Panalgo.

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FDA Health Outcomes Medicaid Medicaid 52