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                Digital Health Center of Excellence

Digital Health Center of Excellence

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    PrintThe Digital Health Reports page houses digital health reports including the biennial Non-Device Software Functions Report and the FDASIA Health IT Report.

Reports on Non-Device Software Functions: Impact to Health and Best Practices

Section 3060(a) of the 21st Century Cures Act, enacted on December 13, 2016 (Pub. L. 114-255), amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to exclude certain software functions from the definition of device under section 201(h) of the FD&C Act (21 U.S.C. 321(h)). These functions are described in section 520(o)(1) of the FD&C Act (21 U.S.C. 360j(o)(1)) and are the focus of this report.

Section 3060(b) of the 21st Century Cures Act requires a report to be published every two years that examines information available to the Secretary on any risks and benefits to health associated with the software functions described in section 520(o)(1) of the FD&C Act, and provides summary findings on the impact of non-device software functions on patient safety, including best practices.

2022 Report on Non-Device Software Functions  (PDF - 1 MB)
	2020 Report on Non-Device Software Functions  (PDF - 6.7 MB)
	2018 Report on Non-Device Software Functions  (PDF - 278KB)FDASIA Health IT Report

On April 3, 2014, the FDA, Federal Communications Commission (FCC), and the Office of the National Coordinator for Health IT (ONC) released the FDASIA Health IT Report outlining a proposed strategy and recommendations for a risk-based framework.

Background

Health information technology, or health IT, is defined by the federal government’s Office of the National Coordinator for Health IT (ONC) as, “hardware, software, integrated technologies or related licenses, intellectual property, upgrades, or packaged solutions sold as services that are designed for or support the use by health care entities or patients for the electronic creation, maintenance, access, or exchange of health information.”

Health IT is the framework that enables the management of health information across multiple electronic systems and devices, such as wireless medical devices, hospital information systems, communications infrastructure, and electronic health record (EHR) systems.  Three federal agencies, the FDA, ONC, and the FCC each have unique responsibilities in the health IT arena.

As health IT evolves, the FDA believes that all stakeholders should understand regulatory requirements surrounding its use. Under the direction of the Food and Drug Administration Safety Innovation Act (FDASIA) of 2012, the FDA worked with FCC and ONC to propose a strategy and make recommendations on an appropriate, risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids unnecessary and duplicative regulation.

The three agencies are committed to a vision that supports a strong health system based on safe and innovative health IT that improves and advances public health.

On 4/3/2014, the FDA, FCC and ONC released the FDASIA Health IT Report outlining a proposed strategy and recommendations for a risk-based framework.

Related Pages

Memorandum of Understanding (MOU) among the Federal Communications Commission, the Office of the National Coordinator for Health Information Technology, and the Food and Drug Administration
	Health IT workgroup to discuss patient safety, innovation, and regulatory efficiency
	Federal Register: Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology Report; Notice to Public of Availability of the Report and Web Site Location; Request for Comments

                                                                                  Content current as of:
      12/08/2022Digital Health Center of Excellence

          
                        Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)
          Digital Health Frequently Asked Questions (FAQs)
          Digital Health Center of Excellence Services
          About the Digital Health Center of Excellence
          Network of Digital Health Experts
          What is Digital Health?
          Cybersecurity
          Digital Health Terms
          Guidances with Digital Health Content
          Digital Health Policy Navigator
          Digital Health Reports
          FDA Digital Health Advisory Committee
          Medical Device Interoperability
          Digital Health Research and Partnerships
          Augmented Reality and Virtual Reality in Medical Devices


                        Diagnostic Data Program
          Software as a Medical Device (SaMD)
          Device Software Functions Including Mobile Medical Applications
          Wireless Medical Devices
          Digital Health Software Precertification (Pre-Cert) Pilot Program
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