[Federal Register Volume 86, Number 101 (Thursday, May 27, 2021)]
[Notices]
[Pages 28601-28602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11186]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Evaluation of Mental 
Health Applications

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Evaluation of 
Mental Health Applications, which is currently being conducted by the 
AHRQ's Evidence-based Practice Centers (EPC) Program. Access to 
published and unpublished pertinent scientific information will improve 
the quality of this review.

DATES: Submission Deadline on or before June 28, 2021.

ADDRESSES:
    Email submissions: [email protected].
    Print submissions:
    Mailing Address: Center for Evidence and Practice Improvement, 
Agency for Healthcare Research and Quality, ATTN: EPC SEADs 
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
    Shipping Address (FedEx, UPS, etc.): Center for Evidence and 
Practice Improvement, Agency for Healthcare Research and Quality, ATTN: 
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, 
MD 20857.

[[Page 28602]]


FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Evaluation of Mental 
Health Applications. AHRQ is conducting this technical brief pursuant 
to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Evaluation of Mental Health Applications, specifically 
the following:
     Characteristics and minimal standards in terms of 
appropriateness and effectiveness of available behavioral health 
applications including adverse events.
     Behavioral health applications assessment frameworks for 
evaluation/scoring tools.
     The entire research protocol is available online at: 
https://effectivehealthcare.ahrq.gov/products/mental-health-apps/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Evaluation of Mental Health Applications 
helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements: study 
number, study period, design, methodology, indication and diagnosis, 
proper use instructions, inclusion and exclusion criteria, primary and 
secondary outcomes, baseline characteristics, number of patients 
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, 
effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on indications not 
included in the review cannot be used by the EPC Program. This is a 
voluntary request for information, and all costs for complying with 
this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
    The technical brief will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

Guiding Key Questions (KQs)

    1. What characteristics and minimal standards of available 
behavioral health mobile applications need to be analyzed in existing 
tools to assess the appropriateness (to various stakeholders) and 
effectiveness of available apps to include, but not limited to:

 Accessibility including ease of use, health literacy, 508 
compliance, digital equity, cost
 App background including funding source, purpose
 Security features and privacy policy such as data ownership/
usage
 Clinical foundation and linkage to current evidence-base
 Usability, including interoperability across platforms, 
stability
 Therapeutic goals, linkage to the provider, crisis warning 
notification/alert system
    2. Identify or develop an assessment framework for evaluation/
scoring tools (e.g., websites) and apply the framework to help 
consumers, family members and peer supports, providers and health 
systems select behavioral health mobile applications. The framework 
will take into account current FDA status on the use and classification 
of risks of apps in healthcare.

    Dated: May 21, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-11186 Filed 5-26-21; 8:45 am]
BILLING CODE 4160-90-P