Lance's Corner

FDA Issues Digital Health Newsletter

Aug 5, 2024

The United States Food and Drug Administration (FDA) has issued its digital health newsletter, which can be read below.

Digital Health Center of Excellence - Updates from CDRH

August 5, 2024

Welcome to the summer edition of DHCoE’s Digital Health Newsletter. Learn about the latest digital health advancements to protect and promote public health.

 

Message from the DHCoE Director

Picture of Troy TazbazIt's no secret that artificial intelligence (AI) is changing the way we think about our health and health care. With more than 850 artificial intelligence-enabled devices authorized by FDA to date, it's clear that this technology is revolutionizing the medical products we use and how we regulate the medical device industry.
But how do we support the proper integration of AI across the health care ecosystem? How can we help AI reach its full potential in health care while reducing the risks and challenges presented by a new technology?
As AI continues to advance with more sophisticated algorithms and more data available than ever before, it's important that we consider ways to align on methodologies, best practices, and quality assurance standards to help all people living in the United States truly benefit from AI's tremendous capability in health care settings.

I explore these concepts and potential approaches for addressing these questions, in my latest blogs.

Troy Tazbaz
Director, Digital Health Center of Excellence

Developer Highlight

New Educational Materials for FDA's Digital Health Technology Guidance

The FDA is offering new educational materials to accompany the Digital Health Technologies for Remote Data Acquisition in Clinical Investigations guidance document. 

  • CDER’s Guidance Snapshot highlights key points in the guidance document, using visuals and plain language.
  • A Guidance Recap Podcast episode includes an interview with Elizabeth Kunkoski (Office of Medical Policy, CDER) and Anindita Saha (DHCoE, CDRH), who discuss the background, intent, and other key recommendations of the guidance document.

These educational materials are designed to increase public awareness of and engagement with the guidance document recommendations. These materials are not substitutes for the guidance document.

 

Patient Highlight

FDA Releases Spanish Versions of Augmented Reality and Virtual Reality Resources for Patients, Caregivers, and Health Care Professionals

Image of the spanish infographicHealth equity is important. That's why the FDA released Spanish translations of two previously available infographics on augmented reality and virtual reality. These translations support Spanish-speaking patients, caregivers, and health care professionals to make informed decisions about medical extended reality in their health care or practice.

View the Spanish infographics.

DHCoE Activities

Update on the FDA's Digital Health Advisory Committee

The FDA is announcing the roster of the Digital Health Advisory Committee. The Digital Health Advisory Committee will advise the FDA on issues related to digital health technologies (DHTs), providing relevant expertise and perspective to enhance the agency’s understanding of the benefits, risks, and clinical outcomes associated with the use of DHTs.

Save the date: On November 20-21, 2024, the FDA plans to hold the inaugural Digital Health Advisory Committee meeting in person in Gaithersburg, MD, with simultaneous webcast. Topics planned to be addressed include how the use of Generative AI may impact safety and effectiveness of medical devices enabled with this technology. In upcoming weeks, further details about this meeting will be announced in the Federal Register in accordance with the FDA’s policies and procedures for Advisory Committee Meetings. Read more.

 

New AI Paper Outlines FDA's Agency-Wide Approach to Protect Public Health and Promote Ethical Innovation

Cover sheet of the reportIn March 2024, the FDA released “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This Paper outlines how FDA’s medical product centers are working together to protect public health while fostering responsible and ethical innovation through AI.
The paper is a joint collaboration between FDA's Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP).

New Guiding Principles Promote Transparency Throughout the Lifecycle of Machine Learning-enabled Devices

First page of the guiding principles
The FDA, Health Canada, and the U.K.’s Medicines and Health care products Regulatory Agency (MHRA) jointly published “Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles."
Integrating these guiding principles across the entirety of the product lifecycle helps improve transparency to the intended user of the device by sharing information about the device that is relevant to them. This information can influence the trust of health care professionals and patients towards a medical device and inform decisions regarding its use.

The International Medical Device Regulators Forum (IMDRF) Seeks Feedback on Proposed Document by August 30

IMDRF's Artificial Intelligence / Machine Learning-enabled Working Group, which FDA co-chairs, is seeking feedback on the proposed document "Good Machine Learning Practice for Medical Device Development - Guiding Principles." Learn more.

 

The Digitally-Derived Endpoints for Freezing-of-Gait Detection (DEFoGD) Challenge is Underway!

A female health care professional assists a man walking.The FDA's Digitally-Derived Endpoints for Freezing-of-Gait Detection (DEFoGD) Challenge seeks AI models to identify and predict freezing of gait (FoG) events related to Parkinson’s disease. These endpoints can foster digital health innovation and may speed up the development of new and effective approaches to helping people with this disease.

Submissions will be accepted through August 2, 2024. The top performing AI models from Phase 1 will advance and be evaluated against validated FoG data in Phase 2.

FDA Announces Five Winners of the Veterans Cardiac Health and AI Model Predictions (V-CHAMPS) Challenge

A health care professional assists a woman.A team of data scientists and clinicians from the FDA, Veterans Health Administration, and National Institute of Standards and Technology did dual-anonymous judging of the entries to select the winners based on performance of model predictions when tested with real-world data. See the winners.

Recent Journal Publication

  • Transparency of artificial intelligence/machine learning-enabled medical devices. This article discusses the views expressed at a virtual public workshop in October 2021 by participants including patients, health care providers, researchers, industry members, regulators, and payors on ways to achieve transparency in AI-enabled medical devices. 

    FDA co-authors include Aubrey A. Shick, Christina M. Webber, Nooshin Kiarashi, Jessica P. Weinberg, Aneesh Deoras, Nicholas Petrick, Anindita Saha & Matthew C. Diamond

 

Contact Us

We value your feedback. Check out our Digital Health Frequently Asked Questions (FAQs). If you have additional questions, please e-mail us at DigitalHealth@fda.hhs.gov.

DHCoE is leading the advancement of digital health to protect and promote public health. Visit our pages on FDA.gov to learn more about digital health products and regulatory policies.

USDOL Issues Comprehensive Employer Guidance on Long COVID

The United States Department of Labor (USDOL) has issued a comprehensive set of resources that can be accessed below for employers on dealing with Long COVID.

Supporting Employees with Long COVID: A Guide for Employers

The “Supporting Employees with Long COVID” guide from the USDOL-funded Employer Assistance and Resource Network on Disability Inclusion (EARN) and Job Accommodation Network (JAN) addresses the basics of Long COVID, including its intersection with mental health, and common workplace supports for different symptoms.  It also explores employers’ responsibilities to provide reasonable accommodations and answers frequently asked questions about Long COVID and employment, including inquiries related to telework and leave.

Download the guide

Accommodation and Compliance: Long COVID

The Long COVID Accommodation and Compliance webpage from the USDOL-funded Job Accommodation Network (JAN) helps employers and employees understand strategies for supporting workers with Long COVID.  Topics include Long COVID in the context of disability under the Americans with Disabilities Act (ADA), specific accommodation ideas based on limitations or work-related functions, common situations and solutions, and questions to consider when identifying effective accommodations for employees with Long COVID.  Find this and other Long COVID resources from JAN, below:

Long COVID, Disability and Underserved Communities: Recommendations for Employers

The research-to-practice brief “Long COVID, Disability and Underserved Communities” synthesizes an extensive review of documents, literature and data sources, conducted by the USDOL-funded Employer Assistance and Resource Network on Disability Inclusion (EARN) on the impact of Long COVID on employment, with a focus on demographic differences.  It also outlines recommended actions organizations can take to create a supportive and inclusive workplace culture for people with Long COVID, especially those with disabilities who belong to other historically underserved groups.

Read the brief

Long COVID and Disability Accommodations in the Workplace

The policy brief “Long COVID and Disability Accommodations in the Workplace” explores Long COVID’s impact on the workforce and provides examples of policy actions different states are taking to help affected people remain at work or return when ready.  It was developed by the National Conference of State Legislatures (NCSL) as part of its involvement in USDOL’s State Exchange on Employment and Disability (SEED) initiative.

Download the policy brief

Understanding and Addressing the Workplace Challenges Related to Long COVID

The report “Understanding and Addressing the Workplace Challenges Related to Long COVID” summarizes key themes and takeaways from an ePolicyWorks national online dialogue through which members of the public were invited to share their experiences and insights regarding workplace challenges posed by Long COVID.  The dialogue took place during summer 2022 and was hosted by USDOL and its agencies in collaboration with the Centers for Disease Control and Prevention and the U.S. Surgeon General.

Download the report

Working with Long COVID

The USDOL-published “Working with Long COVID” fact sheet shares strategies for supporting workers with Long COVID, including accommodations for common symptoms and resources for further guidance and assistance with specific situations.

Download the fact sheet

COVID-19: Long-Term Symptoms

This USDOL motion graphic informs workers with Long COVID that they may be entitled to temporary or long-term supports to help them stay on the job or return to work when ready, and shares where they can find related assistance.

Watch the motion graphic

A Personal Story of Long COVID and Disability Disclosure

In the podcast “A Personal Story of Long COVID and Disability Disclosure,” Pam Bingham, senior program manager for Intuit’s Diversity, Equity and Inclusion in Tech team, shares her personal experience of navigating Long COVID symptoms at work.  The segment was produced by the USDOL-funded Partnership on Employment and Accessible Technology (PEAT) as part of its ongoing “Future of Work” podcast series.

Listen to the podcast

HHS OIG Issues Annual Report on State MFCUs

Per the notice below, the Office of the Inspector General (OIG) of the United States Department of Health and Human Services (HHS) has issued its annual report on the performance of state Medicaid Fraud Control Units (MFCUs).

Medicaid Fraud Control Units Fiscal Year 2023 Annual Report (OEI-09-24-00200) 

Medicaid Fraud Control Units (MFCUs) investigate and prosecute Medicaid provider fraud and patient abuse or neglect. OIG is the Federal agency that oversees and annually approves federal funding for MFCUs through a recertification process. This new report analyzed the statistical data on annual case outcomes—such as convictions, civil settlements and judgments, and recoveries—that the 53 MFCUs submitted for Fiscal Year 2023.  New York data is as follows:

Outcomes

  • Investigations1 - 556
  • Indicted/Charged - 9
  • Convictions - 8
  • Civil Settlements/Judgments - 28
  • Recoveries2 - $73,204,518

Resources

  • MFCU Expenditures3 - $55,964,293
  • Staff on Board4 - 257

1Investigations are defined as the total number of open investigations at the end of the fiscal year.

2Recoveries are defined as the amount of money that defendants are required to pay as a result of a settlement, judgment, or prefiling settlement in criminal and civil cases and may not reflect actual collections.  Recoveries may involve cases that include participation by other Federal and State agencies.

3MFCU and Medicaid Expenditures include both State and Federal expenditures.

4Staff on Board is defined as the total number of staff employed by the Unit at the end of the fiscal year.

Read the Full Report

View the Statistical Chart

Engage with the Interactive Map

GAO Issues Report on Medicaid Managed Care Service Denials and Appeal Outcomes

The United States Government Accountability Office (GAO) has issued a report on federal use of state data on Medicaid managed care service denials and appeal outcomes.  GAO found that federal oversight is limited because it doesn't require states to report on Medicaid managed care service denials or appeal outcomes and there has not been much progress on plans to analyze and make the data publicly available.  To read the GAO report on federal use of state data on Medicaid managed care service denials and appeal outcomes, use the first link below.  To read GAO highlights of the report on federal use of state data on Medicaid managed care service denials and appeal outcomes, use the second link below.
https://www.gao.gov/assets/d24106627.pdf  (GAO report on federal use of state data on Medicaid managed care service denials and appeal outcomes)
https://www.gao.gov/assets/d24106627_high.pdf  (GAO highlights on federal use of state data on Medicaid managed care service denials and appeal outcomes)

CMS Issues Latest Medicare Regulatory Activities Update

The Centers for Medicare and Medicaid Services (CMS) has issued its latest update on its regulatory activities in the Medicare program.  While dentistry is only minimally connected to the Medicare program, Medicare drives the majority of health care policies and insurance reimbursement policies throughout the country.  Therefore, it always pays to keep a close eye on what CMS is doing in Medicare.  To read the latest CMS update on its regulatory activities in Medicare, use the link below.
https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-03-14-mlnc