FACACLASSIC

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HHS - 84710 - Digital Health Advisory Committee - Authorized by Law

GENERAL INFORMATION

Committee Name	Digital Health Advisory Committee	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	84710
Original Establishment Date	10/26/2023	Committee Status	Chartered
Actual Termination Date		Committee URL	https://www.fda.gov/advisory-committees/committ...
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	9
Terminated This FY		Designated Fed Officer Position Title*	Program Analyst, Center for Devices and Radiological Health
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	10/26/2023	Designated Federal Officer First Name*	Letise
Date Of Renewal Charter	10/26/2025	Designated Federal Officer Middle Name
Projected Termination Date		Designated Federal Officer Last Name*	Williams
Exempt From Renewal*	No	Designated Federal Officer Suffix
Specific Termination Authority		Designated Federal Officer Phone*	(301)796-8398
Establishment Authority*	Authorized by Law	Designated Federal Officer Fax*	(301) 847-8505
Specific Establishment Authority*	21 U.S.C. 394	Designated Federal Officer Email*	letise.williams@fda.hhs.gov
Effective Date Of Authority*	10/26/2023
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not Applicable
How does cmte accomplish its purpose?*	The Digital Health Advisory Committee (DHAC) provides advice to the Commissioner of Food and Drugs on complex scientific and technical issues related to Digital Health Technologies (DHTs). This also may include advice on the regulation of DHTs, and/or their use, including use of DHTs in clinical trials or postmarket studies subject to FDA regulation. Topics relating to DHTs, such as artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software, may be considered by the Committee.
How is membership balanced?*	The Committee shall consist of a core of 9 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of digital health, such as artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, software development, user experience, real-world data, real-world evidence, patient-generated health data, interoperability, personalized medicine/genetics, decentralized clinical trials, cybersecurity, and implementation in clinical practice of and patient experience with digital health, as well as other relevant areas. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who serves as an individual, but who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. The Commissioner or designee shall also have the authority to select from a group of individuals nominated by industry to serve temporarily as non-voting members who are identified with and represent industry interests.
How frequent & relevant are cmte mtgs?*	The Digital Health Advisory Committee charter specifies that meetings shall be held approximately twice annually. During the meetings the Committee will provide advice for FDA's consideration as it makes regulatory decisions on complex scientific and technical issues related to digital health technologies. This also may include advice for FDA's consideration on the regulation of DHTs, and/or their use, including use of DHTs in clinical trials or postmarket studies subject to FDA regulation. The Committee had no meeting in FY 2024. The committee has two planned meetings in FY 2025.
Why advice can't be obtained elsewhere?*	The Committee provides relevant expertise and perspective to improve Agency understanding of the benefits, risks, and clinical outcomes associated with use of digital health technologies (DHTs). The Committee performs its duties by providing advice and recommendations for FDA's consideration as it makes regulatory decisions on new approaches to develop and evaluate DHTs and to promote innovation of DHTs, as well as identifying risks, barriers, or unintended consequences that could result from proposed or established Agency policy or regulation for topics related to DHTs.
Why close or partially close meetings?	Not Applicable
Recommendation Remarks	The Committee did not meet in FY 2024 as staff were searching for appropriate candidates to serve as members on this new committee. In addition, time was spent performing required functions for this new committee: the development of a financial report for this website; updating the roster on FDA website; completing the annual ethics report; reviewing financial disclosures and providing ethics training to committee members.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	Yes
Outcome Trust In Government	Yes	Action Reallocate Resources	No
Outcome Major Policy Changes	Yes	Action Issued New Regulations	No
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	No
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	Yes
Outcome Increased Customer Satisfaction	Yes	Action Comment	The Committee will address digital health technologies issues and take appropriate programmatic steps.
Outcome Implement Laws/Reg Requirements	Yes	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	NA	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	The utilization of the Digital Health Advisory Committee enables the Agency to obtain required services from experts who are knowledgeable in the fields of digital health, such as artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, software development, user experience, real-world data, real-world evidence, patient-generated health data, interoperability, personalized medicine/genetics, decentralized clinical trials in the United States not otherwise available to the Agency and to obtain the services of these experts only on an as needed basis rather than on a full-time basis. The services of the Committee resulted in advice for the improvement of the public health for which it is difficult to assign a financial value.	Grants Review Comment	Not Applicable
Number Of Recommendations*	0	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	The Digital Health Advisory Committee has not made any recommendations since its establishment on October 26, 2023	Access Agency Website	Yes
% of Recs Fully Implemented*	0.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	The function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, and therefore, the Agency has the option of not implementing the advice. This number represents an approximation of the percentage of recommendations that the agency has fully implemented or plans to fully implement.	Access GSA FACA Website	Yes
% of Recs Partially Implemented*	0.00%	Access Publications	Yes
% of Recs Partially Implemented Comment	The function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, and therefore, the Agency has the option of not implementing the advice.	Access Other	No
Agency Feedback*	Yes	Access Comment	Not Applicable
Agency Feedback Comment*	When appropriate, information is made available to the public. Actions related to guidance documents or other general matters or issues are available publicly when implemented.	Narrative Description*	FDA’s strategic priorities in responding to the public health challenges of the 21st century are to advance regulatory science and innovation; strengthen the safety and integrity of the global supply chain; strengthen compliance and enforcement activities to support public health; expand efforts to meet the needs of special populations; advance medical countermeasures and emergency preparedness; advance food safety and nutrition; promote public health by advancing the safety and effectiveness of medical products; establish an effective tobacco regulation, prevention, and control program; and manage for organizational excellence and accountability. The Digital Health Advisory Committee supports FDA's mission and strategic action plan by providing advice to the Commissioner of Food and Drugs on complex scientific and technical issues related to digital health technologies (DHTs). This also may include advice on the regulation of DHTs, and/or their use, including use of DHTs in clinical trials or postmarket studies subject to FDA regulation. Topics relating to DHTs, such as artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software, may be considered by the Committee. The Committee performs its duties by providing advice and recommendations on new approaches to develop and evaluate DHTs and to promote innovation of DHTs, as well as identifying risks, barriers, or unintended consequences that could result from proposed or established Agency policy or regulation for topics related to DHTs.

COSTS

1. Payments to Non-Federal Members*		1. Est Paymnts to Non-Fed Membrs Nxt FY*
2. Payments to Federal Members*		2. Est. Payments to Fed Members Next FY*
3. Payments to Federal Staff*		3. Estimated Payments to Federal Staff*
4. Payments to Consultants*		4. Est. Payments to Consultants Next FY*
5. Travel Reimb. For Non-Federal Membrs*		5. Est Travel Reimb Non-Fed Membr nxtFY*
6. Travel Reimb. For Federal Members*		6. Est Travel Reimb For Fed Members*
7. Travel Reimb. For Federal Staff*		7. Est. Travel Reimb to Fed Staf Nxt FY*
8. Travel Reimb. For Consultants*		8. Est Travel Reimb to Consltnts Nxt FY*
10. Other Costs		10. Est. Other Costs Next FY*
11. Total Costs	$0.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	3/14/2025 9:11 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Computer Technology Artificial Intelligence Technology Information Technology Data Data Integrity Data Quality Food and Drugs Food and Drugs Medical Devices Government Federal Government Health Public Health

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