FDA Digital Health Center of Excellence Hosts First Listening Session
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- Published: 20 October 2020 20 October 2020
The Food and Drug Administration (FDA) Digital Health Center of Excellence (DHCoE) held its first listening session with digital health stakeholders on October 19, 2020. Bakul Patel, Director of the DHCoE, stated that advancements in digital health are moving health care from the clinic to the patient. It is essential that innovators in digital health understand patient behavior and focus on wellness and prevention.
A panel of stakeholders urged regulatory clarity for innovations in digital health and adoption of international standards. In particular, the FDA should ensure consistency of approach across divisions of the agency. The industry needs insight into when FDA clearance is required for digital health tools, and when it is not required, and there should be well-defined regulatory pathways. Speakers noted that developers in consumer technology may not be used to dealing with the FDA and will need education on agency processes.
CMS may extend coverage for some telehealth services beyond the COVID-19 Public Health Emergency
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- Published: 15 October 2020 15 October 2020
Back in March 2020, the Centers for Medicare and Medicaid Services (CMS) added several services to the Medicare telehealth services list for the duration of the COVID-19 Public Health Emergency (PHE). Extending coverage of telehealth services was deemed necessary during the pandemic in order to lessen risk of exposure for patients and health care providers while maintaining access to services. In the proposed rule for the calendar year 2021 physician fee schedule, published in the Federal Register on August 17, 2020, CMS requested public comment on extending coverage for certain telehealth services through December 31, 2021, or permanently.
OCR will use enforcement discretion for telehealth during the pandemic
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- Published: 11 May 2020 11 May 2020
The Office for Civil Rights (OCR) of the Department of Health and Human Services has announced that during the COVID-19 national emergency, health care providers may use audio or video communication technology to provide telehealth to patients via popular applications. Ordinarily, providers would need to comply with the HIPAA Security Standards and enter into a business associate agreement with the technology vendor in order to provide HIPAA-compliant telehealth services. However, to make health care services accessible to patients, OCR is allowing providers to use non-public facing remote communication, such as Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, Zoom or Skype. Public facing applications such as Facebook Live should not be used for telehealth.
FCC awards $25 million in Telehealth grants
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- Published: 11 May 2020 11 May 2020
The Coronavirus Aid, Relief and Economic Security (CARES) Act authorized $200 million in grants for telehealth. On April 2, 2020, the Federal Communications Commission (FCC) authorized the COVID-19 Telehealth Program, and invited applications from nonprofit health care entities to fund Telehealth services. As health care providers deal with rapidly expanding numbers of COVID-19 patients, telehealth can help to:
- Provide remote assistance to patients who worry that they may have COVID-19 and need advice on whether to get tested, stay at home or seek care
- Connect hospitalized COVID-19 patients with their families
- Allow remote monitoring of COVID-19 patients, and of other patients with chronic health conditions
- Allow patients other than COVID-19 patients to receive care remotely while avoiding exposure to COVID-19.