{"description":"Documents matching 'Medical Billing Healthcare Software'","count":1640,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=Medical+Billing+Healthcare+Software&format=json&page=2","results":[{"title":"Medical Billing for Healthcare Services Provided by Department of Defense Military Medical Treatment Facilities to Civilian Non-Beneficiaries","type":"Proposed Rule","abstract":"As required by the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 (NDAA-23), this document proposes to reduce financial harm to civilians who are not covered beneficiaries of the Military Health System (MHS), and who receive healthcare services at DoD military medical treatment facilities (MTF). The rulemaking, once finalized, will implement the MHS Modified Payment and Waiver Program (MPWP) through which the DoD will apply a sliding fee scale and/or a catastrophic fee waiver to medical invoices of certain non-beneficiaries and will accept payments from health insurers of non-beneficiaries as full payment except for copays, coinsurance, deductibles, nominal fees and non-covered services.","document_number":"2024-22584","html_url":"https://www.federalregister.gov/documents/2024/10/01/2024-22584/medical-billing-for-healthcare-services-provided-by-department-of-defense-military-medical-treatment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-01/pdf/2024-22584.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-22584.pdf?1727700348","publication_date":"2024-10-01","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":"tribal governments. \n \n List of Subjects in 32 CFR Part 220 \n Accounts receivable, Civilian medical debt, Claims, Healthcare, Health insurance, Medical billing, Medical debt, Medical debt waiver, Military medical treatment facilities, Military personnel, and Third party collections. \n \n Accordingly, the DoD proposes to amend 32 CFR part 220 to read as follows: \n \n PART 220—MEDICAL BILLING FOR HEALTHCARE SERVICES PROVIDED BY DEPARTMENT OF DEFENSE MILITARY MEDICAL TREATMENT FACILITIES TO CIVILIAN NON-BENEFICIARIES \n \n 1. The authority citation for part"},{"title":"Exploration of Health Level Seven Fast Healthcare Interoperability Resources for Use in Study Data Created From Real-World Data Sources for Submission to the Food and Drug Administration; Establishment of a Public Docket; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket for public comments exploring the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) for submission of data collected from real-world data (RWD) sources. In alignment with the new Department of Health and Human Services (HHS), Assistant Secretary for Technology Policy/Office of the National Coordinator for Health (ASTP/ONC) policy on health information technology (health IT), the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are exploring approaches to optimize the submission of structured and standardized clinical study data collected from RWD sources. FDA is seeking public comment from interested parties on specific questions. Interested parties may include regulated industry, health IT vendors, academic medical centers, and electronic data capture vendors as well as other interested parties.","document_number":"2025-06967","html_url":"https://www.federalregister.gov/documents/2025/04/23/2025-06967/exploration-of-health-level-seven-fast-healthcare-interoperability-resources-for-use-in-study-data","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-04-23/pdf/2025-06967.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-06967.pdf?1745325915","publication_date":"2025-04-23","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":"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":" \n \n \n SUPPLEMENTARY INFORMATION: \n I. Background \n Sponsors are increasing their use of RWD to support claims of safety and effectiveness for FDA-regulated medical products. FDA defines RWD as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status”"},{"title":"Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled \"Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.\" This guidance demonstrates FDA's commitment to developing innovative approaches to the regulation of artificial intelligence (AI)-enabled devices. More specifically, this guidance provides recommendations on the information to include in a Predetermined Change Control Plan (PCCP) in a marketing submission for a device that includes one or more AI-enabled device software functions (AI-DSFs). This guidance recommends that a PCCP describe the planned AI-DSF modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP.","document_number":"2024-28361","html_url":"https://www.federalregister.gov/documents/2024/12/04/2024-28361/marketing-submission-recommendations-for-a-predetermined-change-control-plan-for-artificial","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-04/pdf/2024-28361.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-28361.pdf?1733233522","publication_date":"2024-12-04","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":"innovative approaches to the regulation of medical device software and other digital health technologies to ensure their safety and effectiveness. As technology continues to advance all facets of healthcare, medical software incorporating AI, including the subset of AI known as machine learning (ML), has become an important part of many medical devices. In April 2019, FDA published the “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)—Discussion Paper and Request"},{"title":"Registering Emergency Medical Services Agencies Under the Protecting Patient Access to Emergency Medications Act of 2017","type":"Rule","abstract":"The \"Protecting Patient Access to Emergency Medications Act of 2017,\" (the Act) which became law on November 17, 2017, amended the Controlled Substances Act (CSA) to allow for a new registration category for emergency medical services agencies that handle controlled substances. It also established standards for registering emergency medical services agencies, and set forth new requirements for delivery, storage, and recordkeeping related to their handling of controlled substances. In addition, the Act allows emergency medical services professionals to administer controlled substances outside the physical presence of a medical director or authorizing medical professional pursuant to a valid standing or verbal order. The Drug Enforcement Administration is publishing this final rule to conform its regulations to the statutory amendments of the CSA and to otherwise implement its requirements. This final rule adopts, with minor modifications, the notice of proposed rulemaking published on October 5, 2020.","document_number":"2026-02288","html_url":"https://www.federalregister.gov/documents/2026/02/05/2026-02288/registering-emergency-medical-services-agencies-under-the-protecting-patient-access-to-emergency","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-05/pdf/2026-02288.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-02288.pdf?1770153307","publication_date":"2026-02-05","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"substances outside the physical presence of a medical director or authorizing medical professional in the course of providing emergency medical services.\n 15 \n \n Medical directors and EMS professionals authorized to administer controlled substances under their State license may administer controlled substances in the course of providing emergency medical services. However, under 21 U.S.C. 823(k)(4) and § 1306.07(g), an EMS professional who is outside the physical presence of a medical director or authorizing medical professional must not only have authority"},{"title":"Prohibition on Creditors and Consumer Reporting Agencies Concerning Medical Information (Regulation V)","type":"Rule","abstract":"The Consumer Financial Protection Bureau (CFPB) is issuing a final rule amending Regulation V, which implements the Fair Credit Reporting Act (FCRA), concerning medical information. The FCRA prohibits creditors from considering medical information in credit eligibility determinations. The CFPB is removing a regulatory exception that had permitted creditors to obtain and use information on medical debts notwithstanding this statutory limitation. The final rule also provides that a consumer reporting agency generally may not furnish to a creditor a consumer report containing information on medical debt that the creditor is prohibited from using.","document_number":"2024-30824","html_url":"https://www.federalregister.gov/documents/2025/01/14/2024-30824/prohibition-on-creditors-and-consumer-reporting-agencies-concerning-medical-information-regulation-v","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-14/pdf/2024-30824.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-30824.pdf?1736775917","publication_date":"2025-01-14","agencies":[{"raw_name":"Consumer Financial Protection Bureau","name":"Consumer Financial Protection Bureau","id":573,"url":"https://www.federalregister.gov/agencies/consumer-financial-protection-bureau","json_url":"https://www.federalregister.gov/api/v1/agencies/573","parent_id":null,"slug":"consumer-financial-protection-bureau"}],"excerpts":"1, \n Medical Information Related to Debts, \n the CFPB finalizes its definition of medical debt information in final § 1022.3(j), as medical information that pertains to a debt owed by a consumer to a person whose primary business is providing medical services, products, or devices (also referred to herein as a health care provider), or to the person's agent or assignee, for the provision of such medical services, products, or devices. The definition also provides that medical debt information includes, but is not limited to, medical bills that are"},{"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Postnatal Chromosomal Copy Number Variation Detection System","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is classifying the postnatal chromosomal copy number variation detection system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the postnatal chromosomal copy number variation detection system's classification. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","document_number":"2025-16032","html_url":"https://www.federalregister.gov/documents/2025/08/21/2025-16032/medical-devices-immunology-and-microbiology-devices-classification-of-the-postnatal-chromosomal-copy","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-21/pdf/2025-16032.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-16032.pdf?1755693958","publication_date":"2025-08-21","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":"terms of chromosomal coverage and probe density for different regions; \n (C) An identification of the number of probes and size of the CNVs reported at the lower range of the assay; \n (D) Detailed documentation of the device software, including standalone software applications and hardware-based devices that incorporate software; \n (E) Methodology and protocols for detecting copy number and visualizing results; \n (F) A description of the result outputs along with sample reports, and a description of any links to external databases provided by the device"},{"title":"Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 065","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled \"Modifications to the List of Recognized Standards, Recognition List Number: 065\" (Recognition List Number: 065), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.","document_number":"2026-03310","html_url":"https://www.federalregister.gov/documents/2026/02/19/2026-03310/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-19/pdf/2026-03310.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03310.pdf?1771422323","publication_date":"2026-02-19","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":"Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” The guidance describes how FDA has implemented its standards recognition program and is available at \n https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices. \n Modifications to the initial list of recognized standards, as published in the \n Federal Register \n , can be accessed at \n https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents"},{"title":"Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the devices included in this document. FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the Federal Register.","document_number":"2026-02377","html_url":"https://www.federalregister.gov/documents/2026/02/06/2026-02377/medical-devices-exemptions-from-premarket-notification-class-ii-devices-request-for-comments","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-06/pdf/2026-02377.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-02377.pdf?1770299117","publication_date":"2026-02-06","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":"5570 \n Container, sharps \n MMK \n Exemption is limited to devices that meet the following conditions: \n \n \n \n \n \n 1. Device is intended for single use; \n \n \n \n \n \n 2. Device is intended to be used in a healthcare setting; \n \n \n \n \n \n 3. Device is intended to contain only sharps for disposal; \n \n \n \n \n \n 4. Device does not include software or electronic components; and \n \n \n \n \n \n 5. Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ISO 23908, “Sharps injury protection—Requirements"},{"title":"Request for Information Regarding Diagnostic Excellence Measurement; Reopening of Comment Period","type":"Notice","abstract":"The Agency for Healthcare Research and Quality (AHRQ) invites public comment in response to this Request for Information (RFI) on the development of measures of diagnostic excellence that may be calculated using administrative data or electronic health record (EHR) data. The purpose of diagnostic excellence measurement is to identify potential opportunities to improve the diagnostic process at a health system or geographic level. AHRQ welcomes comments on the importance and usability of existing measures and those that may be under development.","document_number":"2025-03752","html_url":"https://www.federalregister.gov/documents/2025/03/10/2025-03752/request-for-information-regarding-diagnostic-excellence-measurement-reopening-of-comment-period","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-03-10/pdf/2025-03752.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-03752.pdf?1741355114","publication_date":"2025-03-10","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":"Foundation. The AHRQ Quality Indicators (QI) Program develops indicators of healthcare quality and patient safety in a variety of healthcare settings. The QI Program is actively engaged in collecting information on measures that can contribute to diagnostic excellence measurement. AHRQ is considering measures that rely on administrative claims data (for state and regional health departments with limited access to clinical data), as well as electronic health record data (for healthcare systems with full access to clinical data). AHRQ aims to address gaps"},{"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test","type":"Rule","abstract":"The Food and Drug Administration (FDA) is classifying the SARS-CoV-2 serology test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the SARS- CoV-2 serology test. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","document_number":"2026-12902","html_url":"https://www.federalregister.gov/documents/2026/06/26/2026-12902/medical-devices-immunology-and-microbiology-devices-classification-of-the-sars-cov-2-serology-test","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-26/pdf/2026-12902.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12902.pdf?1782391512","publication_date":"2026-06-26","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":"result (\n e.g., \n how collected raw signals are converted into a reported signal and result), as applicable to the detection method and device design;\n \n (vi) For devices with associated software or instrumentation, documentation must include a detailed description of device software, including software applications and hardware-based devices that incorporate software. The detailed description must include documentation of verification, validation, and hazard analysis and risk assessment activities, including an assessment of the impact of threats and"},{"title":"Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus","type":"Rule","abstract":"The Food and Drug Administration (FDA) is classifying the combined acoustic and electrical external stimulation device for the relief of tinnitus into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the combined acoustic and electrical external stimulation device for the relief of tinnitus. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","document_number":"2026-11589","html_url":"https://www.federalregister.gov/documents/2026/06/10/2026-11589/medical-devices-ear-nose-and-throat-devices-classification-of-the-combined-acoustic-and-electrical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-10/pdf/2026-11589.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11589.pdf?1781009111","publication_date":"2026-06-10","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 electrical safety of the device. \n (4) Software verification, validation, and hazard analysis must be performed. \n (5) The patient-contacting components of the device must be demonstrated to be biocompatible. \n (6) Human factors testing must demonstrate that users can successfully use the device in the intended use environment based solely on its labeling and instructions for use. \n (7) Labeling must include the following: \n (i) A statement that the device is intended to be prescribed by a healthcare professional with expertise in the evaluation"},{"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples","type":"Rule","abstract":"The Food and Drug Administration (FDA) is classifying the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","document_number":"2026-12443","html_url":"https://www.federalregister.gov/documents/2026/06/22/2026-12443/medical-devices-immunology-and-microbiology-devices-classification-of-the-simple-in-vitro-diagnostic","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-22/pdf/2026-12443.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12443.pdf?1781786720","publication_date":"2026-06-22","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":"FDA, an equivalent sample set. This study must include samples spanning all relevant analyte concentrations for all of the indicated sample type(s) and the targeted analyte(s). \n (iv) A detailed description of the impact of any software, including software applications and hardware-based devices that incorporate software, on the device's functions, as applicable. \n (v) For any devices that detect the presence of an analyte directly from sample, detailed documentation and results from a shelf-life assessment that includes samples formulated in the"},{"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings","type":"Rule","abstract":"The Food and Drug Administration (FDA) is classifying the simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","document_number":"2026-11739","html_url":"https://www.federalregister.gov/documents/2026/06/11/2026-11739/medical-devices-immunology-and-microbiology-devices-classification-of-the-simple-point-of-care","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-11/pdf/2026-11739.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11739.pdf?1781095520","publication_date":"2026-06-11","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":"usability studies and user label comprehension), flex studies, and performance with weakly-reactive samples in the hands of the intended user(s);\n \n (viii) For devices with associated software or instrumentation, documentation must include a detailed description of device software, including software applications and hardware-based devices that incorporate software. The detailed description must include documentation of verification, validation, and hazard analysis and risk assessment activities, including an assessment of the impact of threats and"},{"title":"Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 064","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled \"Modifications to the List of Recognized Standards, Recognition List Number: 064\" (Recognition List Number: 064), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.","document_number":"2025-11792","html_url":"https://www.federalregister.gov/documents/2025/06/26/2025-11792/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-26/pdf/2025-11792.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11792.pdf?1750855518","publication_date":"2025-06-26","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":"Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” The guidance describes how FDA has implemented its standards recognition program and is available at \n https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices. \n Modifications to the initial list of recognized standards, as published in the \n Federal Register \n , can be accessed at \n https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents"},{"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the DNA-Based Test To Measure Minimal Residual Disease in Hematological Malignancies","type":"Rule","abstract":"The Food and Drug Administration (FDA, Agency, or we) is classifying the DNA-based test to measure minimal residual disease in hematological malignancies into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the DNA-based test to measure minimal residual disease in hematological malignancies classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","document_number":"2025-08143","html_url":"https://www.federalregister.gov/documents/2025/05/09/2025-08143/medical-devices-immunology-and-microbiology-devices-classification-of-the-dna-based-test-to-measure","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-09/pdf/2025-08143.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-08143.pdf?1746708318","publication_date":"2025-05-09","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":"test is indicated for use by qualified healthcare professionals in accordance with professional guidelines for clinical decision-making, in conjunction with other clinicopathological features.\n \n \n (b) \n Classification. \n Class II (special controls). The special controls for this device are:\n \n (1) Design verification and validation must include: \n (i) A detailed description of the device, including: \n (A) A detailed description of all test components, reagents, instrumentation, and software, including software applications and any hardware-based devices"},{"title":"Privacy Act of 1974; System of Records","type":"Notice","abstract":"Pursuant to the Privacy Act of 1974, notice is hereby given that VA is modifying the system of records titled, \"National Patient Databases-VA\" (121VA10). VA provides health care services to many Veterans through VHA. During the course of providing health care, VHA collects medical and health information about Veterans under their care. This system is used for planning, distribution, and utilization of resources; monitoring the performance of VHA programs and Veteran population health; and statistical analysis of clinical and administrative support provided within VHA.","document_number":"2025-15587","html_url":"https://www.federalregister.gov/documents/2025/08/15/2025-15587/privacy-act-of-1974-system-of-records","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-15/pdf/2025-15587.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-15587.pdf?1755175532","publication_date":"2025-08-15","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":"Quality Standards (MQS) VA \n Durham VA Medical Center, 508 Fulton Street, Durham, NC 27705. \n \n \n Medical Software as a Service (SAS) File Medical District Planning (MDP) (Medical District Initiated Peer Review Organization (MEDIPRO)) \n Austin Information Technology Center, 1615 Woodward Street, Austin, TX 78772. \n \n \n Multiple Sclerosis Surveillance Registry (MSSR) \n Austin Information Technology Center, 1615 Woodward Street, Austin, TX 78772. \n \n \n Public Health National Program Office (PHNPO) \n Palo Alto VA Medical Center, 3801 Miranda Avenue, Palo"},{"title":"Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Initial and Reconciliation Application Forms To Report Graduate Medical Education Data and Full-Time Equivalent Residents Trained by Hospitals Participating in the Children's Hospitals Graduate Medical Education Payment Program; and FTE Resident Assessment Forms To Report FTE Residents Trained by Organizations Participating in the CHGME Payment Program and the Teaching Health Center Graduate Medical Education Program, OMB No. 0915-0247-Revision","type":"Notice","abstract":"In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.","document_number":"2025-18774","html_url":"https://www.federalregister.gov/documents/2025/09/29/2025-18774/agency-information-collection-activities-submission-to-omb-for-review-and-approval-public-comment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-29/pdf/2025-18774.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18774.pdf?1758890708","publication_date":"2025-09-29","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":"Health Resources and Services Administration","name":"Health Resources and Services Administration","id":222,"url":"https://www.federalregister.gov/agencies/health-resources-and-services-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/222","parent_id":221,"slug":"health-resources-and-services-administration"}],"excerpts":"Application Forms to Report Graduate Medical Education Data and Full-Time Equivalent Residents Trained by Hospitals Participating in the Children's Hospitals Graduate Medical Education Payment Program; and Full-Time Equivalent Resident Assessment Forms to Report Full-Time Equivalent Residents Trained by Organizations Participating in the Children's Hospitals Graduate Medical Education Payment Program and the Teaching Health Center Graduate Medical Education Program, OMB No. 0915-0247—Revision.\n \n \n Abstract: \n The Healthcare Research and Quality Act of 1999"},{"title":"Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2027","type":"Proposed Rule","abstract":"This rule proposes changes and updates to the policies and payment rates used under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for fiscal year 2027. This proposed rule also updates the requirements for the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program.","document_number":"2026-06674","html_url":"https://www.federalregister.gov/documents/2026/04/07/2026-06674/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-07/pdf/2026-06674.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06674.pdf?1775164507","publication_date":"2026-04-07","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":"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":"for Skilled Nursing Facility (SNF) Quality Reporting Program (QRP). \n \n \n SNF HAI \n SNF Healthcare-Associated Infections (HAI) Requiring Hospitalization. \n \n \n \n National Healthcare Safety Network \n \n \n \n HCP COVID-19 Vaccine \n COVID-19 Vaccination Coverage among Healthcare Personnel (HCP). \n \n \n HCP Influenza Vaccine \n Influenza Vaccination Coverage among Healthcare Personnel (HCP). \n \n \n C. Proposal To Remove the COVID-19 Vaccination Coverage Among Healthcare Personnel (HCP) Measure Beginning With the FY 2028 SNF QRP \n We refer readers to the FY"},{"title":"Proposed Data Collection Submitted for Public Comment and Recommendations","type":"Notice","abstract":"The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National HIV Surveillance System (NHSS). The NHSS collects comprehensive population-based data on persons living with HIV in the U.S. and its territories, utilizing standard reporting from laboratories and healthcare providers to monitor trends, estimate incidence and prevalence, analyze drug resistance, detect and monitor clusters, and inform public health planning and resource allocation at federal, state and local levels and by HIV prevention and care partners.","document_number":"2025-18904","html_url":"https://www.federalregister.gov/documents/2025/09/30/2025-18904/proposed-data-collection-submitted-for-public-comment-and-recommendations","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-30/pdf/2025-18904.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18904.pdf?1759149910","publication_date":"2025-09-30","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":"persons, detect and respond to HIV clusters of recent and rapid transmission, and monitor perinatal exposures. NHSS data are also used locally to identify persons with HIV who are not in medical care and linking them to care and needed services. NHSS data continue to be collected, maintained, and reported using standard case definitions, report forms and software. The system is periodically updated as needed to keep pace with changes in testing technology and advances in HIV care and treatment, as well as changing prevention program monitoring and"},{"title":"Request for Information Regarding Diagnostic Excellence Measurement","type":"Notice","abstract":"The Agency for Healthcare Research and Quality (AHRQ) invites public comment in response to this Request for Information (RFI) on the development of measures of diagnostic excellence that may be calculated using administrative data or electronic health record (EHR) data. The purpose of diagnostic excellence measurement is to identify potential opportunities to improve the diagnostic process at a health system or geographic level. AHRQ welcomes comments on the importance and usability of existing measures and those that may be under development.","document_number":"2024-29134","html_url":"https://www.federalregister.gov/documents/2024/12/12/2024-29134/request-for-information-regarding-diagnostic-excellence-measurement","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-12/pdf/2024-29134.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-29134.pdf?1733924728","publication_date":"2024-12-12","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":"Foundation. The AHRQ Quality Indicators (QI) Program develops indicators of healthcare quality and patient safety in a variety of healthcare settings. The QI Program is actively engaged in collecting information on measures that can contribute to diagnostic excellence measurement. AHRQ is considering measures that rely on administrative claims data (for state and regional health departments with limited access to clinical data), as well as electronic health record data (for healthcare systems with full access to clinical data). AHRQ aims to address gaps"}]}