- Published: 29 October 2020 29 October 2020
The Office of the National Coordinator for Health Information Technology (ONC) has issued an interim final rule extending the compliance dates for the information blocking and health information technology (HIT) certification requirements established in the ONC Cures Act Final Rule published on May 1, 2020. The ONC determined these extensions were necessary because health care providers and HIT developers are currently focused on response to the COVID-19 pandemic (including electronic reporting of COVID cases).
The original effective date for compliance with the information blocking rules was November 2, 2020; this is moved to April 5, 2021. The purpose of the information blocking rules is to prevent providers and developers from adopting practices that interfere with a patient’s ability to access, or to authorize the exchange of, the patient’s electronic health information. The ONC Cures Act Final Rule limited the applicability to certain core data until May 2, 2022; this period is now extended to October 6, 2022.
- Published: 27 October 2020 27 October 2020
The Food and Drug Administration (FDA) has published a discussion paper on communicating cybersecurity vulnerabilities to patients, in preparation for the October 2020 meeting of the Patient Engagement Advisory Committee of the FDA’s Center for Devices and Radiologic Health. The FDA has recognized that cybersecurity risks pose significant patient safety concerns for connected medical devices. The term “connected medical devices” includes medical devices that are connected to the internet, to hospital networks, or to other medical devices. Examples are sensor-based technologies such as wearables, to implantable medical devices such as pacemakers.
- 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.
- 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.