2024-11878. 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.

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 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 [e-mail] 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: [e-mail]. Telephone: [phone].

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?

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

Acronym	Definition
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.

Dated: May 23, 2024.

Marquita Cullom,

Associate Director.