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On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued final guidance entitled, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring,” (the Final Guidance) to provide clarification on its enforcement policies and premarket review expectations for certain non-invasive remote monitoring devices used for patient monitoring at the conclusion of the COVID-19 public health emergency (PHE). Specifically, the FDA will continue to allow most remote monitoring devices to be used in home settings and to allow certain hardware or software changes to allow for increased remote monitoring capabilities under enforcement discretion.

Continue Reading FDA Issues Final Guidance on Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring

On December 22, 2023, FDA issued final guidance–Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. This final guidance is aimed at sponsors and others who may be involved in remote data acquisition for clinical trials to evaluate medical products. As digital health technologies (DHTs) used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research the FDA is providing guidance for ensuring that technologies used are safe, appropriate, and store and transmit data appropriately. Highlights of the guidance are below.

Continue Reading FDA Releases Guidance on Digital Health Technologies for Clinical Investigations  

On October 11, the National Institutes of Health (“NIH”) issued a request for information (“RFI”), which proposes sample language regarding the use of digital health technologies in research for inclusion in informed consent documents and requests public feedback on the utility and usability of the proposed language. Comments on the RFI are due by December 12, 2023.

Continue Reading NIH Requests Information on Developing Consent Language for Research Using Digital Health Technologies

As we move into 2023, the impact of the pandemic on marginalized groups continue. The COVID 19-pandemic has exacerbated longstanding racial and ethnic disparities in health care. In terms of national healthcare spending, healthcare inequities make up about $230 billion in annual spending; and that amount could potentially reach $1 trillion by the year 2040 if inequities persist or worsen. In 2021, the Centers for Medicare & Medicaid Services (CMS) announced a new strategic vision to guide the Centers’ model testing and priorities toward a vision of achieving equitable outcomes through high-quality, affordable, person-centered care. But it is important to also highlight what other federal agencies, states, and health plans are doing to address health inequity especially as our healthcare system, as a whole, is moving towards value-based care initiatives.

Continue Reading Health Sector Efforts to Address Health Equity and Affordability in 2023

On January 31, 2022, the U.S. Food & Drug Administration (FDA) published a notice in the Federal Register announcing the availability of a final guidance for industry and FDA staff entitled “Principles of Premarket Pathways for Combination Products”. The final guidance is available on the FDA’s website. It provides FDA’s current thinking on principles for premarket review of combination products. It finalizes previously available draft guidance, dated February 6, 2019, which altogether are part of FDA’s efforts to implement section 3038 of the 21st Century Cures Act expressly addressing combination products. The final guidance is nonbinding.
Continue Reading FDA Finalizes Guidance on Combination Products

On October 27, 2021, the U.S. Food and Drug Administration (FDA) in collaboration with Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), published Guiding Principles for the use of artificial intelligence and machine learning (AI/ML) in medical devices.   The principles are designed to support good machine learning practices (GMLP) and to help promote safe, effective, and high-quality medical devices that use AI/ML. The FDA is accepting public comment on these principles on an ongoing basis.
Continue Reading FDA Publishes Principles for AI and ML in Medical Devices

In September 2019, the Food & Drug Administration (FDA) issued a new draft “Clinical Decision Support Software” guidance for public comments, which are due December 26, 2019. Concurrently, the agency published updates to four related guidance documents centered on regulation of digital health software products along with a consolidated summary titled “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act,”[1] but is not soliciting comment on those. All of these guidance documents now account for the exclusion of certain software functions from the definition of “device” under the 21st Century Cures Act (Cures Act) amendments to the Food, Drug, and Cosmetic Act (FDCA) in 2016 and clarify FDA’s enforcement and monitoring positions vis-à-vis its legal authorities.

The rapid expansion of software and mobile medical applications in health care has made this guidance necessary in order to manage the FDA’s regulatory scope and provide clarity to medical device and health care companies seeking to use more software and mobile app solutions in their products and services. Digital health stakeholders, particularly medical device manufacturers, software developers, and mobile medical application developers should consider the effect of these guidance documents on their go-to-market strategies and submit comments regarding items from the FDA’s newest guidance documents that would create unnecessary burden or not address patient safety issues or other risks that FDA seeks to mitigate. We summarize the key points of each of the FDA’s guidance documents below.Continue Reading FDA Seeks Comment on Clinical Decision Support Software Guidance and Issues Policy Updates on its Oversight Authority Regarding Medical Software and Apps

Yesterday, the FDA released draft guidance on the management of cybersecurity in medical devices submitted to the agency for premarket review. Noting that cybersecurity threats to the healthcare sector have increased in number and severity, the FDA offered new recommendations for device design, labeling, and documentation that medical device manufacturers will need to consider during premarket submission processes.

The guidance comes shortly after the FDA’s launch of its Medical Device Cybersecurity Playbook, which provides a framework for healthcare delivery organizations to use in preparing for and responding to cybersecurity threats against patient medical devices.

Given rapid changes in technology and increasing innovation in the digital health market, the guidance intends to decrease the risk of cyberattacks that could render medical devices inoperable and potentially harm patients. Comments on the draft guidance are due on March 18, 2019.
Continue Reading FDA Issues New Guidance for the Management of Cybersecurity in Medical Devices

On April 17, 2018, the Food and Drug Administration (FDA) released its Medical Device Safety Action Plan which outlines FDA’s intended steps to address medical device safety while preserving enough space for innovation in the market.

The FDA’s plan is the latest effort by the FDA on medical device safety, including a recent budget request seeking $70 million to create a Center of Excellence on Digital Health that would, among other things, craft new regulations for third-party certification for developing medical devices. This comes as FDA is pushing guidance and innovative approaches for oversight of digital health (see our blog).

According to FDA Commissioner Scott Gottlieb’s announcement, the FDA’s plan organized into five points that seek to balance patients’ timely access to devices and safety and effectiveness.
Continue Reading FDA’s Medical Device Safety Action Plan

The Food and Drug Administration (FDA) has announced several new initiatives that reflect its ongoing commitment to maintain patient safety, while also championing the need and opportunity for health care innovation.

During opening day of Health Datapalooza, FDA Commissioner Scott Gottlieb highlighted the critical import of novel digital health tools in achieving patient-centered care, and outlined how the agency is committed to moving the ball forward in health care innovation through the following initiatives:
Continue Reading FDA Advances Flexibility-Based Framework for Digital Health and AI