The digital health space refers to the integration of technology and health care services to improve the overall quality of health care delivery. It encompasses a wide range of innovative and emerging technologies such as wearables, telehealth, artificial intelligence, mobile health, and electronic health records (EHRs). The digital health space offers numerous benefits such as improved patient outcomes, increased access to health care, reduced costs, and improved communication and collaboration between patients and health care providers. For example, patients can now monitor their vital signs such as blood pressure and glucose levels from home using wearable devices and share the data with their doctors in real-time. Telehealth technology allows patients to consult with their health care providers remotely without having to travel to the hospital, making health care more accessible, particularly in remote or rural areas. Artificial intelligence can be used to analyze vast amounts of patient data to identify patterns, predict outcomes, and provide personalized treatment recommendations. Overall, the digital health space is rapidly evolving, and the integration of technology in health

Monday, September 23, 2013

FDA Releases Final Guidance for Mobile Health Applications

 

 

Monday, September 23, 2013

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On Monday, FDA issued final guidance for mobile health applications, Reuters reports (Clarke, Reuters, 9/23).

Background

In 2011, FDA requested public comment on how it should regulate smartphones, tablet computers and apps that collect health information or are used to monitor medical conditions (iHealthBeat, 6/26).

According to FDA, the agency has approved about 100 mobile medical apps over the last decade, about 40 of which have received clearance over the past two years (Dolan, MobiHealthNews, 9/23).

Details of Final Rule

According to the final rule, FDA will focus oversight on apps that:

  • Were developed to be used as accessories to regulated medical devices, such as apps that allow health care providers to make diagnoses by viewing medical images on smartphones or tablets; or
  • Can transform mobile devices into regulated medical devices, such as apps that allow a smartphone to be used as an electrocardiography machine.

Note:  Information is curated from iHealthBeat, a publication of the California Health  Care Foundation (CHCF

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