FDA News and Resources for Healthcare

Studies on Prescription Digital Therapeutics Lack Rigor, Inclusivity

November 7, 2023 - The clinical evidence supporting prescription digital therapeutics (PDTs) is lacking, with studies frequently excluding older adults and people not proficient in English and missing race and ethnicity information of study participants, according to a new study. Published in Health Affairs, the study aimed to identify emerging trends in the clinical...

FDA Creates Advisory Committee for Digital Health Technology

October 13, 2023 by Anuja Vaidya

The United States Food and Drug Administration has created a Digital Health Advisory Committee to support the agency’s efforts to explore the scientific and technical issues related to using...

Telehealth Company Faces Charges for Neglecting FDA Requirements

April 19, 2023 by Mark Melchionna

Previously known as Opternative Inc, a telehealth company named Visibly, Inc. is facing charges after describing its services as accurate and fair without receiving approvals from the US Food and Drug...

DiMe, FDA, Amazon Eye Best Practices for Sensors in mHealth Devices

October 21, 2021 by Eric Wicklund

The Digital Medicine Society (DiMe) is collaborating with the US Food and Drug Administration and some heavy hitters in the technology market to develop best practices for integrating mHealth sensors...

CMS Plans to Scrap Innovative mHealth Technology Program

September 14, 2021 by Eric Wicklund

Federal officials are ditching a plan to speed up Medicare coverage for innovative mHealth technology, saying the Trump-era plan would have put patients at risk. The Centers for Medicare &...

HHS, FDA Backtrack From Plan to Deregulate mHealth Devices, Apps

April 22, 2021 by Eric Wicklund

Federal officials are quietly withdrawing a Trump administration plan to end regulatory review of 83 types of mHealth devices, saying the original plan was flawed and could have put the lives of...

FDA Touts mHealth Expertise With Digital Health Center of Excellence

September 22, 2020 by Eric Wicklund

The US Food and Drug Administration has unveiled the Digital Health Center of Excellence, aimed at supporting mHealth and telehealth tools. “Establishing the Digital Health Center of Excellence...

Telemedicine Abortion Ban Dooms Passage of Long-Awaited PA Telehealth Bill

April 23, 2020 by Eric Wicklund

A long-awaited bill aiming to establish new guidelines for telehealth in Pennsylvania – including coverage parity – will apparently go down in flames because it bans telemedicine...

FDA Eases Guidelines for New mHealth, Telemental Health Treatments

April 21, 2020 by Eric Wicklund

With the Coronavirus pandemic putting a strain on the mental health of both patients and providers, federal officials are easing up on regulations for mHealth and apps and telehealth services to push...

AI-Powered Smartphone App Offers Coronavirus Risk Assessment

March 13, 2020 by Samantha McGrail

A smartphone app coupled with artificial intelligence and machine intelligence will increase access to at-home COVID-19 risk assessments, which will help provide health officials with real-time...

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