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Digital Health Technologies

All articles tagged with #digital health technologies

health-technology2 years ago•2 min saved

"FDA Forms Committee to Guide Digital Health Technology"

The U.S. Food and Drug Administration (FDA) has announced the establishment of a new Digital Health Advisory Committee to address the scientific and technical aspects of digital health technologies (DHTs) such as artificial intelligence, virtual reality, wearables, and remote patient monitoring. The committee will provide expertise and guidance to improve the FDA's understanding of the benefits, risks, and clinical outcomes associated with DHTs. Its goal is to support the development of safe and effective digital health technologies while promoting innovation and health equity. The committee will consist of nine voting members and will be fully operational in 2024.

via FDA.gov|

#digital-health-advisory-committee #digital-health-technologies #fda

healthcare2 years ago•2 min saved

Advancing Decentralized Clinical Trials for Drugs, Biological Products, and Devices: FDA's Latest Steps.

The FDA has released a new draft guidance to support the use of decentralized clinical trials (DCTs) for drugs, biologics, and devices. DCTs allow some or all trial-related activities to take place at trial participants’ homes or other convenient locations, increasing the breadth and diversity of participants in clinical trials and improving accessibility for those with rare diseases or mobility challenges. The guidance covers recommendations on design considerations, remote clinical trial visits, use of digital health technologies, roles and responsibilities of sponsors and investigators, obtaining informed consent, and safety monitoring of trial participants. The FDA expects that DCTs will play an important role in addressing public health needs and improving patient outcomes.

via FDA.gov|

#decentralized-clinical-trials #digital-health-technologies #fda