[Federal Register Volume 89, Number 107 (Monday, June 3, 2024)]
[Notices]
[Pages 47561-47563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11878]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


CDS Connect--Designing the Future of a National Hub for Clinical 
Decision Support: Request for Information

AGENCY: Agency for Healthcare Research and Quality, Department of 
Health and Human Services.

ACTION: Notice of Request for Information regarding a sustainment model 
for CDS Connect.

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SUMMARY: Clinical decision support (CDS) enables providers and others 
to implement up-to-date research findings quickly into their practice. 
In 2016, the Agency for Healthcare Research and Quality (AHRQ) 
supported the development of (CDS) by establishing

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CDS Connect, a platform to assist the healthcare community in creating 
and disseminating CDS artifacts. In 2023, AHRQ conducted a CDS Connect 
Challenge Competition to identify business models and platform 
enhancements that will allow CDS Connect to evolve its role as a 
national CDS hub. Based on the results of this Challenge Competition, 
AHRQ has issued the following Request for Information (RFI) to solicit 
ideas and identify possible collaborators for creating a new 
sustainment model (such as a Public Private Partnership [PPP] between 
AHRQ and a third-party organization) that ensures CDS Connect's future 
operations.

DATES: Comments on this notice must be received on or before July 31, 
2024.

ADDRESSES: Interested parties may submit comments electronically to 
[email protected] with the subject ``CDS Connect 
RFI.''

FOR FURTHER INFORMATION CONTACT: Questions may be addressed to Mario 
Teran, MD, MSc, Division of Digital Healthcare Research in the Center 
for Evidence and Practice Improvement at AHRQ. Email: 
[email protected]. Telephone: 301-427-1498.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality (AHRQ) seeks public comment about strategies and approaches to 
advancing shareable, interoperable, and reusable clinical decision 
support (CDS) resources. AHRQ seeks comment on models and possible 
partnerships to strengthen and sustain CDS Connect as a national hub 
for clinical decision support. CDS Connect enables the creation of 
standards-based CDS resources (sometimes called CDS ``artifacts'') and 
the integration of evidence-based care data into clinical practice 
through electronic health systems and applications.
    Established in 2016, CDS Connect has steadily grown in 
functionality and use. It enjoys an active following of diverse 
stakeholders and users, including various electronic health record 
(EHR) developers, CDS developers, other health information technology 
(health IT), healthcare advocacy organizations, federal and local 
government representatives, clinicians, patients, and caregivers. CDS 
Connect offers a repository of CDS artifacts, a standards-based CDS 
Authoring Tool, and multiple open-source tools and resources (available 
on the CDS Connect Technical Resources web page).
    In October 2023, AHRQ conducted a challenge competition to solicit 
innovative approaches and input on the future design and sustainability 
of CDS Connect. AHRQ obtained valuable insight and information from the 
competition, including identifying collaborative models that have the 
potential to sustain and further develop CDS Connect as a public 
resource. This Request for Information (RFI) incorporates vital 
takeaways from the challenge competition to help inform the public's 
responses to questions posed in the RFI. However, possible future 
models for CDS Connect are not limited to the ideas generated during 
the Challenge Competition; AHRQ encourages suggesting alternate and 
innovative approaches. AHRQ also welcomes information on any 
sustainment models that respondents feel are appropriate for AHRQ to 
consider, including collaborative relationships with industry, e.g., 
public-private partnerships.
    The challenge competition identified several possible CDS Connect 
enhancements:
     Enhancing the user experience, including mechanisms for 
users to obtain support and provide feedback.
     Additional educational or training resources should be 
provided to support a variety of users.
     Leveraging, facilitating, and promoting CDS and health 
information technology standards.
     Artificial intelligence (AI) is introduced into CDS 
Connect, ranging from AI-based mechanisms to develop CDS artifacts to 
using large language models (LLMs) and AI-based artifact maintenance.
     Creating processes, standards, and tools to assist and 
accelerate CDS development through successive levels of computability 
and readiness for real-world implementation.
     Developing and making available a more significant number 
of executable CDS artifacts.
     Expanding the number of CDS artifacts at all levels in the 
repository.
     Integrating directly within EHR systems.
     Creating a ``sandbox'' allows potential users to sample, 
test, and deploy CDS artifacts in real-time scenarios before selecting/
purchasing them.
    The Challenge Competition highlighted several possible business 
models to enable long-term sustainability.
     Removing the restriction that CDS artifacts in the 
Repository be made available free of charge, allowing for revenue 
opportunities through fee-based services.
     Adopting standardized and commercial-friendly licensing 
and compensation models (e.g., licensing to EHR and other CDS vendors 
to integrate artifacts into their systems; subscription-based fees for 
access to CDS artifacts or applications).
     Developing enhanced functionality and subscription models 
for different types of users (e.g., individuals, EHR vendors, CDS 
vendors, nonprofit organizations, for-profit organizations).
     Requiring a one-time or ad hoc payment to use CDS 
Connect's services or products (e.g., to access artifacts in the 
Repository or use the Authoring Tool).
     Offering different tiers of service capabilities at 
different costs, such as a ``Freemium'' model allowing access to 
publicly funded CDS Connect artifacts and a basic form of the Authoring 
Tool without charge, but imposing a cost for additional services (e.g., 
possible built-out features) and support.
     Establishing a payment incentive for independent 
individuals, developers, EHR vendors, CDS vendors, or others; in turn, 
content can be offered to end users at a cost.
    AHRQ is exploring collaborative initiatives with private industry, 
academia, and nonprofit entities to identify potential sustainment 
paths. AHRQ is interested in exploring a PPP to continue CDS Connect's 
operation and expansion.

List of Questions/Components

    AHRQ invites stakeholders and other interested parties to submit 
ideas on the future of shareable, interoperable, and reusable CDS 
resources, particularly on sustainment models for CDS Connect. 
Submissions should address the qualifications of potential partnering 
organizations, the proposed governance structure of a PPP, the content 
of improvements to the CDS Connect platform, the business model 
(including costs), and community engagement.
    Responses can also address the following questions:

Questions Related to CDS Connect

General

    1. What areas of expertise are essential for potential partnering 
organizations to possess in a PPP with AHRQ to grow and sustain CDS 
Connect?
    2. If submitting as a potential partnering organization, what are 
the organization's interests and expertise in CDS, health information 
technology, and/or healthcare modernization?

Value Proposition

    3. What is the value of a platform like CDS Connect?

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    4. What can be done to improve the value of CDS Connect to 
clinicians, patients, CDS developers, and other stakeholders?

Governance

    5. What governance structure and framework does the submitting 
organization envision for the PPP (or other sustainment model)?
    6. How would the PPP (or other sustainment model) operate, 
accounting for the involvement of AHRQ, other federal agencies, or 
other potential external partners?

Content

    7. What suggestions (if any) would be proposed to modify or enhance 
the CDS Connect Repository, CDS artifacts within the CDS Connect 
Repository, and/or the CDS Connect Authoring Tool?
    8. If submitting as an organization, what other suggestions does 
the submitting organization have to modify or enhance CDS Connect's 
content and/or capabilities?
    9. What existing infrastructure can support these suggested 
modifications or enhancements, or what additional infrastructure would 
be needed? What are the barriers or general feasibility issues to 
implementation?

Business Model

    10. What business model(s) can ensure that CDS Connect remains 
sustainable (e.g., a PPP or other sustainment model)?
    11. If submitting as an organization, what are the submitting 
organization's suggested mechanisms of models for generating revenue 
that will enable a sustainable PPP (or other sustainment model)?
    12. What are the anticipated project start-up costs for the 
proposed business model?

General Questions About CDS

    1. How can CDS become more shareable, interoperable, and reusable, 
in particular, please identify:
    a. Enablers;
    b. Barriers;
    c. Potential role(s) for AHRQ and other federal agencies;
    d. Sustainable models for collaborative relationships among 
government agencies, academic institutions, private industry, non-
profit organizations, patient advocacy groups, and other stakeholders.
    2. What are sustainable approaches for scaling CDS, including AI-
based methods, to under-served settings that may not have the staff and 
resources to develop CDS on their own or to purchase CDS resources 
(e.g., modules, services) from their EHR provider or other health IT 
providers?

Who Should Respond

    AHRQ welcomes responses from any stakeholders interested in the 
continued sustainment and growth of CDS Connect. AHRQ is interested in 
perspectives from:

 Private industry
 Participants of similar public-private collaboratives
 Developers and users of CDS, including academic institutions, 
clinicians, patients, payers, and research organizations

                                Acronyms
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                Acronym                             Definition
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AHRQ...................................  Agency for Healthcare Research
                                          and Quality.
AI.....................................  Artificial Intelligence.
CDS....................................  Clinical Decision Support.
CMS....................................  Centers for Medicare & Medicaid
                                          Services (HHS).
EHR....................................  Electronic Health Record.
FFRDC..................................  Federally Funded Research and
                                          Development Center.
HHS....................................  U.S. Department of Health and
                                          Human Services.
LLM....................................  Large Language Model.
PCOR...................................  Patient-centered outcomes
                                          research.
PPP....................................  Public Private Partnership.
RFI....................................  Request For Information.
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    Dated: May 23, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-11878 Filed 5-31-24; 8:45 am]
BILLING CODE 4160-90-P