{"description":"Documents matching 'clinical decision support'","count":7159,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=clinical+decision+support&format=json&page=2","results":[{"title":"Notice of Meeting","type":"Notice","abstract":"The Agency for Healthcare Research and Quality (AHRQ) announces a Special Emphasis Panel (SEP) meeting on \"Implementing and Evaluating Patient-Centered Clinical Decision Support Strategies in Real-World Settings(U18)\"","document_number":"2024-30336","html_url":"https://www.federalregister.gov/documents/2024/12/20/2024-30336/notice-of-meeting","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-20/pdf/2024-30336.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-30336.pdf?1734615916","publication_date":"2024-12-20","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Agency for Healthcare Research and Quality","name":"Agency for Healthcare Research and Quality","id":5,"url":"https://www.federalregister.gov/agencies/agency-for-healthcare-research-and-quality","json_url":"https://www.federalregister.gov/api/v1/agencies/5","parent_id":221,"slug":"agency-for-healthcare-research-and-quality"}],"excerpts":"applications for AHRQ <span class=\"match\">support</span>. Individual members of the Panel do not attend regularly scheduled meetings and do not serve for fixed terms or a long period of time. Rather, they are asked to participate in particular review meetings which require their type of expertise. \n \n The SEP meeting referenced above will be closed to the public in accordance with the provisions set forth in 5 U.S.C. 1009(d), 5 U.S.C. 552b(c)(4), and 5 U.S.C. 552b(c)(6). Grant applications for “Implementing and Evaluating Patient-Centered <span class=\"match\">Clinical</span> <span class=\"match\">Decision</span> <span class=\"match\">Support</span> Strategies in Real-World"},{"title":"Privacy Act of 1974; System of Records","type":"Notice","abstract":"As required by the Privacy Act of 1974, notice is hereby given that VA is modifying the system of records titled \"VHA Corporate Data Warehouses-VA\" (172VA10). This system is used for clinical decision support, mobile applications presenting patient data, and statistical analysis to produce various management, workload tracking, and follow- up reports. It is also used to track and evaluate the ordering and delivery of equipment, services, and patient care; track the planning, distribution, and utilization of resources; monitor the performance of Veterans Integrated Service Networks; and allocate clinical and administrative support to patient medical care.","document_number":"2025-17710","html_url":"https://www.federalregister.gov/documents/2025/09/15/2025-17710/privacy-act-of-1974-system-of-records","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-15/pdf/2025-17710.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-17710.pdf?1757681108","publication_date":"2025-09-15","agencies":[{"raw_name":"DEPARTMENT OF VETERANS AFFAIRS","name":"Veterans Affairs Department","id":520,"url":"https://www.federalregister.gov/agencies/veterans-affairs-department","json_url":"https://www.federalregister.gov/api/v1/agencies/520","parent_id":null,"slug":"veterans-affairs-department"}],"excerpts":"Warehouses-VA” (172VA10). This system is used for <span class=\"match\">clinical</span> <span class=\"match\">decision</span> <span class=\"match\">support</span>, mobile applications presenting patient data, and statistical analysis to produce various management, workload tracking, and follow-up reports. It is also used to track and evaluate the ordering and delivery of equipment, services, and patient care; track the planning, distribution, and utilization of resources; monitor the performance of Veterans Integrated Service Networks; and allocate <span class=\"match\">clinical</span> and administrative <span class=\"match\">support</span> to patient medical care. \n \n \n DATES: \n \n Comments"},{"title":"CDS Connect-Designing the Future of a National Hub for Clinical Decision Support: Request for Information","type":"Notice","abstract":"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.","document_number":"2024-11878","html_url":"https://www.federalregister.gov/documents/2024/06/03/2024-11878/cds-connect-designing-the-future-of-a-national-hub-for-clinical-decision-support-request-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-03/pdf/2024-11878.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-11878.pdf?1717159514","publication_date":"2024-06-03","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Agency for Healthcare Research and Quality","name":"Agency for Healthcare Research and Quality","id":5,"url":"https://www.federalregister.gov/agencies/agency-for-healthcare-research-and-quality","json_url":"https://www.federalregister.gov/api/v1/agencies/5","parent_id":221,"slug":"agency-for-healthcare-research-and-quality"}],"excerpts":"seeks public comment about strategies and approaches to advancing shareable, interoperable, and reusable <span class=\"match\">clinical</span> <span class=\"match\">decision</span> <span class=\"match\">support</span> (CDS) resources. AHRQ seeks comment on models and possible partnerships to strengthen and sustain CDS Connect as a national hub for <span class=\"match\">clinical</span> <span class=\"match\">decision</span> <span class=\"match\">support</span>. CDS Connect enables the creation of standards-based CDS resources (sometimes called CDS “artifacts”) and the integration of evidence-based care data into <span class=\"match\">clinical</span> practice through electronic health systems and applications. \n Established in 2016, CDS Connect has steadily"},{"title":"Draft CDC's Recommendations for HIV Screening in Clinical Settings","type":"Notice","abstract":"The Centers for Disease Control and Prevention in the Department of Health and Human Services announces the opening of a docket to obtain comment on the draft Recommendations for HIV Screening in Clinical Settings, that update portions of CDC's \"Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings,\" published in 2006.","document_number":"2024-28294","html_url":"https://www.federalregister.gov/documents/2024/12/03/2024-28294/draft-cdcs-recommendations-for-hiv-screening-in-clinical-settings","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-03/pdf/2024-28294.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-28294.pdf?1733147129","publication_date":"2024-12-03","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Disease Control and Prevention","name":"Centers for Disease Control and Prevention","id":44,"url":"https://www.federalregister.gov/agencies/centers-for-disease-control-and-prevention","json_url":"https://www.federalregister.gov/api/v1/agencies/44","parent_id":221,"slug":"centers-for-disease-control-and-prevention"}],"excerpts":"nchhstppolicy@cdc.gov. \n Office phone: 404-639-0485.\n \n \n \n \n SUPPLEMENTARY INFORMATION: \n CDC is requesting public comment on the draft “Recommendations for HIV Screening in <span class=\"match\">Clinical</span> Settings,” which is available on regulations.gov in Docket CDC-2024-0100. These recommendations modify the ages for HIV screening including eliminating an upper age limit, encourage providers to use <span class=\"match\">clinical</span> <span class=\"match\">decision</span> <span class=\"match\">support</span> tools such as automated HIV test laboratory orders to implement HIV screening, provide considerations for healthcare populations on which to conduct HIV screening"},{"title":"Request for Information Regarding the Impact of Ageism in Healthcare","type":"Notice","abstract":"The Agency for Healthcare Research and Quality (AHRQ) is seeking information from the public to understand the impacts of ageism on healthcare quality, including aspects related to safety, timeliness, patient-centeredness, equitable distribution, and care outcomes. How does the effect of ageism differ across different population groups? We are interested in identifying efforts and innovative strategies and programs that address and mitigate ageism to optimize older adults' health.","document_number":"2024-31074","html_url":"https://www.federalregister.gov/documents/2024/12/27/2024-31074/request-for-information-regarding-the-impact-of-ageism-in-healthcare","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-27/pdf/2024-31074.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31074.pdf?1735220735","publication_date":"2024-12-27","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Agency for Healthcare Research and Quality","name":"Agency for Healthcare Research and Quality","id":5,"url":"https://www.federalregister.gov/agencies/agency-for-healthcare-research-and-quality","json_url":"https://www.federalregister.gov/api/v1/agencies/5","parent_id":221,"slug":"agency-for-healthcare-research-and-quality"}],"excerpts":"their families, and caregivers. \n • Patient advocacy groups and organizations. \n • <span class=\"match\">Clinical</span> <span class=\"match\">decision</span> <span class=\"match\">support</span> developers. \n • Quality and other measure developers. \n • Representatives from human service agencies and/or community organizations with interest or experience in addressing ageism. \n • Higher education institutions that train clinicians and healthcare personnel and/or train those involved in community health and education. \n • <span class=\"match\">Clinical</span> and public health <span class=\"match\">decision</span>-makers. \n • Health technology developers focused on improving health outcomes among"},{"title":"Request for Information; Health Technology Ecosystem","type":"Notice","abstract":"Effective and responsible adoption of technology can empower patients to make better decisions for their health and well-being. This request for information (RFI) seeks input from the public regarding the market of digital health products for Medicare beneficiaries as well as the state of data interoperability and broader health technology infrastructure. Responses to this RFI may be used to inform CMS and ASTP/ONC efforts to lead infrastructure progress to cultivate this market, increasing beneficiary access to effective digital capabilities needed to make informed health decisions, and increasing data availability for all stakeholders contributing to health outcomes.","document_number":"2025-08701","html_url":"https://www.federalregister.gov/documents/2025/05/16/2025-08701/request-for-information-health-technology-ecosystem","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-16/pdf/2025-08701.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-08701.pdf?1747149309","publication_date":"2025-05-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"FHIR—Do you <span class=\"match\">support</span> both EHR-launched and standalone app access? What does the process for application deployment entail? \n i. CDS Hooks (for <span class=\"match\">clinical</span> <span class=\"match\">decision</span> <span class=\"match\">support</span> integrations). \n PR-6. Is TEFCA currently helping to advance provider access to health information? \n a. Please provide specific examples. \n b. What changes would you suggest? \n c. What other options are available outside of TEFCA? \n d. Are there redundant standards, protocols or channels or both that could be consolidated? \n PR-7. What strategies can CMS implement to <span class=\"match\">support</span> providers"},{"title":"AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is issuing this request for information to solicit input on a proposed pilot program to assess how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision- making in early phase clinical trials. Early-phase clinical trials represent a critical bottleneck in drug development, often characterized by high uncertainty, limited patient populations, and inefficient decision- making processes. This pilot program aims to explore how advances in AI and data science can improve trial efficiency, enhance safety monitoring, facilitate dose selection decisions, and enable more informed early go/no-go decisions (e.g., a regulatory decision as to whether a Phase 1 study may proceed) while maintaining FDA's rigorous scientific and regulatory standards and promoting trustworthy AI systems. The pilot program will be guided by principles aligned with the National Institute of Standards and Technology (NIST) AI Risk Management Framework (AI RMF).","document_number":"2026-08281","html_url":"https://www.federalregister.gov/documents/2026/04/29/2026-08281/ai-enabled-optimization-of-early-phase-clinical-trials-pilot-program-request-for-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-29/pdf/2026-08281.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08281.pdf?1777389315","publication_date":"2026-04-29","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"efficiency, speed, and quality of <span class=\"match\">decision</span>-making in early phase <span class=\"match\">clinical</span> trials. Early-phase <span class=\"match\">clinical</span> trials represent a critical bottleneck in drug development, often characterized by high uncertainty, limited patient populations, and inefficient <span class=\"match\">decision</span>-\n \n making processes. This pilot program aims to explore how advances in AI and data science can improve trial efficiency, enhance safety monitoring, facilitate dose selection <span class=\"match\">decisions</span>, and enable more informed early go/no-go <span class=\"match\">decisions</span> (\n e.g., \n a regulatory <span class=\"match\">decision</span> as to whether a Phase 1 study"},{"title":"Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity","type":"Proposed Rule","abstract":"This proposed rule focuses on deregulatory actions identified in HHS regulations regarding Health information technology standards, implementation specifications, and certification criteria and certification programs for health information technology, and information blocking. This proposed rule seeks to reduce burden, offer flexibility to both developers and providers, and support innovation through the removal and revisions of certain certification criteria and regulatory provisions. This proposed rule also seeks to address reported misuse and abuse of information blocking definitions and exceptions.","document_number":"2025-23896","html_url":"https://www.federalregister.gov/documents/2025/12/29/2025-23896/health-data-technology-and-interoperability-astponc-deregulatory-actions-to-unleash-prosperity","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-29/pdf/2025-23896.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23896.pdf?1766438109","publication_date":"2025-12-29","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"Criteria for Health Information Technology \n 1. <span class=\"match\">Clinical</span> Certification Criteria \n a. Patient Demographics \n b. <span class=\"match\">Clinical</span> <span class=\"match\">Decision</span> <span class=\"match\">Support</span> \n c. Family Health History \n d. Implantable Device List \n 2. Care Coordination Certification Criteria \n a. Transitions of Care \n b. <span class=\"match\">Clinical</span> Information Reconciliation and Incorporation \n c. Security Tags—Summary of Care \n d. Care Plan \n e. <span class=\"match\">Decision</span> <span class=\"match\">Support</span> Interventions \n 3. <span class=\"match\">Clinical</span> Quality Measures Certification Criteria \n a. <span class=\"match\">Clinical</span> Quality Measures—Report \n b. <span class=\"match\">Clinical</span> Quality Measures—Filter \n 4. Privacy and Security"},{"title":"Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance entitled \"Use of Real- World Evidence to Support Regulatory Decision-Making for Medical Devices.\" FDA is issuing this guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This final guidance supersedes the final guidance, \"Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,\" issued August 31, 2017, and provides expanded and updated recommendations.","document_number":"2025-23252","html_url":"https://www.federalregister.gov/documents/2025/12/18/2025-23252/use-of-real-world-evidence-to-support-regulatory-decision-making-for-medical-devices-guidance-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-18/pdf/2025-23252.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23252.pdf?1765979123","publication_date":"2025-12-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"availability of a final guidance entitled “Use of Real-World Evidence to <span class=\"match\">Support</span> Regulatory <span class=\"match\">Decision</span>-Making for Medical Devices.” FDA is issuing this guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory <span class=\"match\">decision</span>-making for medical devices. This final guidance supersedes the final guidance, “Use of Real-World Evidence to <span class=\"match\">Support</span> Regulatory <span class=\"match\">Decision</span>-Making for Medical Devices,” issued August 31, 2017, and provides expanded"},{"title":"E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials.\" The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide general principles on the conduct of clinical trials that include pregnant and breastfeeding women to inform evidence-based decisions on safe and effective use of medicinal products by these populations. The draft guidance includes approaches to generating data that support informed decision-making on the safety, dosing, and efficacy of medicinal products during pregnancy and breastfeeding. Additionally, the draft guidance includes recommendations for recruiting and retaining pregnant and breastfeeding women in clinical trials, while reducing burden and harm on these participants.","document_number":"2025-13680","html_url":"https://www.federalregister.gov/documents/2025/07/21/2025-13680/e21-inclusion-of-pregnant-and-breastfeeding-women-in-clinical-trials-international-council-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-21/pdf/2025-13680.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13680.pdf?1752842718","publication_date":"2025-07-21","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Breastfeeding Women in <span class=\"match\">Clinical</span> Trials.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide general principles on the conduct of <span class=\"match\">clinical</span> trials that include pregnant and breastfeeding women to inform evidence-based <span class=\"match\">decisions</span> on safe and effective use of medicinal products by these populations. The draft guidance includes approaches to generating data that <span class=\"match\">support</span> informed <span class=\"match\">decision</span>-making on the safety"},{"title":"Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments","type":"Notice","abstract":"Digital health technologies (DHTs) used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research. As outlined in the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VII) included as part of the FDA User Fee Reauthorization Act of 2022, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have committed to supporting the use of DHTs in drug and biological product development. To inform potential FDA activities in this area, CDER and CBER are requesting information to better understand the opportunities and challenges sponsors and other interested parties face in making innovative use of DHTs in clinical investigations of drugs and biological products.","document_number":"2026-06184","html_url":"https://www.federalregister.gov/documents/2026/03/31/2026-06184/advancing-the-use-of-digital-health-technologies-in-clinical-investigations-for-drugs-and-biological","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-31/pdf/2026-06184.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06184.pdf?1774874715","publication_date":"2026-03-31","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"and use of DHTs to collect data for <span class=\"match\">clinical</span> investigation endpoints.\n \n Since the publication of the 2023 DHT Guidance, there have been considerable advances in technology that may be used in <span class=\"match\">clinical</span> investigations. The range of sensors and the <span class=\"match\">clinical</span> features they can measure has expanded. Many of these sensors are present in smartwatches and mobile phones and may be customized using mobile applications (apps) for <span class=\"match\">clinical</span> investigations. Apps and other DHTs are being designed to perform interactive <span class=\"match\">clinical</span> tests of patient function. Examples"},{"title":"TRICARE Coverage of Clinical Trials and Termination of Expanded Access Treatments","type":"Rule","abstract":"The Assistant Secretary of Defense for Health Affairs (ASD(HA)) issues this final rule regarding circumstances under which services and supplies related to emerging treatments may be covered under the TRICARE program. This rule finalizes provisions published in two interim final rules (IFRs) with request for comment, which temporarily added coverage for the treatment use of investigational drugs under U.S. Food and Drug Administration (FDA)-authorized expanded access (EA) programs when for the treatment of coronavirus disease 2019 (COVID-19) and permitted coverage of National Institute of Allergy and Infectious Disease (NIAID)-sponsored clinical trials for the treatment or prevention of COVID-19. This final rule discusses the DoD's decision not to make permanent the coverage of treatment use of investigational drugs under FDA EA programs while updating language for care associated with their administration and broadens the COVID-19 clinical trial benefit to include coverage of clinical trials sponsored or approved by any National Institutes of Health (NIH) Center or Institute to treat or prevent infectious diseases associated with a pandemic or epidemic. Lastly, the final rule expands TRICARE's clinical trial benefit by covering services and supplies provided in conjunction with Phase I, II, III, and IV clinical trials that are NIH-sponsored or approved and that involve a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition, provided that the condition is severely debilitating, life- threatening, or a rare disease.","document_number":"2025-14206","html_url":"https://www.federalregister.gov/documents/2025/07/28/2025-14206/tricare-coverage-of-clinical-trials-and-termination-of-expanded-access-treatments","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-28/pdf/2025-14206.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14206.pdf?1753447522","publication_date":"2025-07-28","agencies":[{"raw_name":"DEPARTMENT OF DEFENSE","name":"Defense Department","id":103,"url":"https://www.federalregister.gov/agencies/defense-department","json_url":"https://www.federalregister.gov/api/v1/agencies/103","parent_id":null,"slug":"defense-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"disease. This includes expanding coverage of cancer <span class=\"match\">clinical</span> trials to National Cancer Institute (NCI)-sponsored or approved Phase I-IV <span class=\"match\">clinical</span> trials, rather than only NCI-sponsored Phase I-III <span class=\"match\">clinical</span> trials, as cancer is itself a life-threatening condition. This expansion of TRICARE's <span class=\"match\">clinical</span> trial benefit conforms to statutory authority and is <span class=\"match\">supported</span> by the DoD's review into the <span class=\"match\">clinical</span> trials reimbursement landscape and the comments the DoD received in response to the COVID-19 <span class=\"match\">Clinical</span> Trials IFR. \n I. Background \n A. Statement of Need"},{"title":"Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Clinical Decision Support Software.\" This final guidance provides clarity on FDA's oversight of clinical decision support (CDS) software intended for health care professionals with the purpose of describing FDA's regulatory approach to CDS software functions. This guidance clarifies the types of CDS functions that do not meet the definition of a device as amended by the 21st Century Cures Act (Cures Act).","document_number":"2022-20993","html_url":"https://www.federalregister.gov/documents/2022/09/28/2022-20993/clinical-decision-support-software-guidance-for-industry-and-food-and-drug-administration-staff","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-09-28/pdf/2022-20993.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-20993.pdf?1664282726","publication_date":"2022-09-28","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"ACTION: \n Notice of availability. \n \n \n SUMMARY: \n The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “<span class=\"match\">Clinical</span> <span class=\"match\">Decision</span> <span class=\"match\">Support</span> Software.” This final guidance provides clarity on FDA's oversight of <span class=\"match\">clinical</span> <span class=\"match\">decision</span> <span class=\"match\">support</span> (CDS) software intended for health care professionals with the purpose of describing FDA's regulatory approach to CDS software functions. This guidance clarifies the types of CDS functions that do not meet the definition of a device as amended by the 21st Century Cures"},{"title":"Center for Scientific Review; Notice of Closed Meetings","type":"Notice","abstract":null,"document_number":"2023-21572","html_url":"https://www.federalregister.gov/documents/2023/10/02/2023-21572/center-for-scientific-review-notice-of-closed-meetings","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-10-02/pdf/2023-21572.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-21572.pdf?1695991553","publication_date":"2023-10-02","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"National Institutes of Health","name":"National Institutes of Health","id":353,"url":"https://www.federalregister.gov/agencies/national-institutes-of-health","json_url":"https://www.federalregister.gov/api/v1/agencies/353","parent_id":221,"slug":"national-institutes-of-health"}],"excerpts":"Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301-806-6596, \n rubertm@csr.nih.gov \n .\n \n \n Name of Committee: \n Center for Scientific Review Special Emphasis Panel; Risk Prediction and <span class=\"match\">Clinical</span> <span class=\"match\">Decision</span> <span class=\"match\">Support</span>.\n \n \n Date: \n November 2-3, 2023.\n \n \n Time: \n 9:00 a.m. to 6:00 p.m.\n \n \n Agenda: \n To review and evaluate grant applications.\n \n \n Place: \n National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).\n \n \n Contact Person:"},{"title":"Request for Information: Accelerating the Adoption and Use of Artificial Intelligence as Part of Clinical Care","type":"Notice","abstract":"The HHS Office of the Deputy Secretary in collaboration with ASTP/ONC has published this Request for Information (RFI) to seek broad public comment on what HHS can do to accelerate the adoption and use of AI as part of clinical care.","document_number":"2025-23641","html_url":"https://www.federalregister.gov/documents/2025/12/23/2025-23641/request-for-information-accelerating-the-adoption-and-use-of-artificial-intelligence-as-part-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-23/pdf/2025-23641.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23641.pdf?1766151927","publication_date":"2025-12-23","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"high-\n \n value AI <span class=\"match\">clinical</span> interventions, foster competition among <span class=\"match\">clinical</span> care AI tool builders, and accelerate access to and affordability of AI tools for <span class=\"match\">clinical</span> care.\n \n Research &amp; Development \n HHS <span class=\"match\">supports</span> one of the world's largest health research ecosystems, catalyzing innovation to supplement the market. By enabling applied AI research &amp; development, care delivery research and implementation science, as well as AI entrepreneurship in health care, we can better translate AI technologies from concept to <span class=\"match\">clinical</span> use. We seek input"},{"title":"Announcement of Requirements and Registration for “EHIgnite Challenge”","type":"Notice","abstract":"The EHIgnite Challenge addresses data usability challenges in single patient electronic health information (EHI) exports. This challenge seeks to incentivize the development of tools, platforms, and workflows that transform single patient EHI exports into usable, readable, and actionable information that supports clinical care, patient engagement, and informed decision-making.","document_number":"2026-10068","html_url":"https://www.federalregister.gov/documents/2026/05/20/2026-10068/announcement-of-requirements-and-registration-for-ehignite-challenge","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-20/pdf/2026-10068.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10068.pdf?1779117307","publication_date":"2026-05-20","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"single patient electronic health information (EHI) exports. This challenge seeks to incentivize the development of tools, platforms, and workflows that transform single patient EHI exports into usable, readable, and actionable information that <span class=\"match\">supports</span> <span class=\"match\">clinical</span> care, patient engagement, and informed <span class=\"match\">decision</span>-making. \n \n \n DATES: \n This challenge includes two phases. Only the participants selected to receive a Phase 1 prize may participate in Phase 2. \n \n \n • \n Phase 1: \n Concept &amp; Design\n \n \n Submission period begins: \n February 23, 2026, 10:00"},{"title":"Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, FDA staff, and other stakeholders entitled \"Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.\" This guidance (Guidance 3) is the third in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, researchers, medical product developers, and others) can submit patient experience and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making. This guidance finalizes the draft guidance of the same title issued on June 30, 2022.","document_number":"2025-20153","html_url":"https://www.federalregister.gov/documents/2025/11/18/2025-20153/patient-focused-drug-development-selecting-developing-or-modifying-fit-for-purpose-clinical-outcome","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-18/pdf/2025-20153.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20153.pdf?1763387133","publication_date":"2025-11-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"patient and caregiver input that can more consistently inform medical product development and regulatory <span class=\"match\">decision</span>-making. Guidance 3 discusses approaches to selecting, modifying, developing, and evaluating <span class=\"match\">clinical</span> outcome assessments to measure outcomes of importance to patients in <span class=\"match\">clinical</span> trials. \n This guidance finalizes the draft guidance entitled “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose <span class=\"match\">Clinical</span> Outcome Assessments” issued on June 30, 2022 (87 FR 39101). FDA considered comments received on the draft"},{"title":"Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Comment Request","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.\" In accordance with its mission of protecting, promoting, and advancing public health, FDA's Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM), the Oncology Center of Excellence (OCE), the Office of Combination Products (OCP), and the Office of Inspections and Investigations (OII), is issuing this draft guidance to provide recommendations to industry on the use of artificial intelligence (AI) to produce information or data intended to support regulatory decision-making regarding the safety, effectiveness, or quality for drug and biological products.","document_number":"2024-31542","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31542/considerations-for-the-use-of-artificial-intelligence-to-support-regulatory-decision-making-for-drug","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31542.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31542.pdf?1736171122","publication_date":"2025-01-07","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"SUPPLEMENTARY INFORMATION: \n I. Background \n FDA is announcing the availability of a draft guidance entitled “Considerations for the Use of Artificial Intelligence To <span class=\"match\">Support</span> Regulatory <span class=\"match\">Decision</span>-Making for Drug and Biological Products.” This draft guidance, when finalized, will provide recommendations to industry on the use of AI to produce information or data intended to <span class=\"match\">support</span> regulatory <span class=\"match\">decision</span>-making regarding safety, effectiveness, or quality for drugs. Specifically, this guidance proposes a risk-based credibility assessment framework that may be used"},{"title":"Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products.\" FDA is issuing this guidance as part of its Real-World Evidence (RWE) program and to satisfy, in part, the mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision making. This guidance is intended to provide sponsors and other interested parties with considerations when proposing to use electronic health records (EHRs) or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety. This guidance finalizes the draft guidance of the same title issued on September 30, 2021.","document_number":"2024-16338","html_url":"https://www.federalregister.gov/documents/2024/07/25/2024-16338/real-world-data-assessing-electronic-health-records-and-medical-claims-data-to-support-regulatory","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-25/pdf/2024-16338.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-16338.pdf?1721825128","publication_date":"2024-07-25","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Data To <span class=\"match\">Support</span> Regulatory <span class=\"match\">Decision</span>-Making for Drug and Biological Products.” FDA is issuing this guidance as part of its Real-World Evidence (RWE) program and to satisfy, in part, the mandate under the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) to issue guidance about the use of RWE in regulatory <span class=\"match\">decision</span> making. This guidance is intended to provide sponsors and other interested parties with considerations when proposing to use electronic health records (EHRs) or medical claims data in <span class=\"match\">clinical</span> studies to <span class=\"match\">support</span> a regulatory <span class=\"match\">decision</span> for"},{"title":"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.","document_number":"2026-08552","html_url":"https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08552.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08552.pdf?1777553125","publication_date":"2026-05-01","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"to reflect new evidence or analysis regarding <span class=\"match\">clinical</span> need. FDA intends to then publish in the \n Federal Register \n a final determination identifying the bulk drug substances for which we have determined there is a <span class=\"match\">clinical</span> need and our rationale in making that final determination. FDA also intends to publish a final determination in the \n Federal Register \n for those substances which we considered but found that there is no <span class=\"match\">clinical</span> need to use in compounding and our rationale in making this <span class=\"match\">decision</span>.\n \n \n \n 11 \n  This is consistent with procedure"}]}