/ en Wed, 25 Jun 2025 20:38:45 -0500 Tue, 17 Jun 25 06:00:00 -0500 /aha-center-health-innovation-market-scan/2025-06-17-cvs-healths-next-big-goal-solve-interoperability <div class="container"><div class="row"><div class="col-md-8"><img src="/sites/default/files/inline-images/CVS-Healths-Next-Big-Goal-Solve-Interoperability.png" data-entity-uuid="105cc3af-d06e-46a4-a018-381f823e5f27" data-entity-type="file" alt="CVS Health’s Next Big Goal: Solve Interoperability. The CVS logo connected to a number of healthcare icons." width="1200" height="677"><p>CVS Health has never been shy about having lofty goals to reshape health care. So, when news broke recently that the mega retailer plans to invest $20 billion in technology over the next 10 years to deliver a more consumer-centric health experience by improving interoperability of health tech systems, it’s reasonable to wonder if the company may be biting off more than it can chew.</p><p>The investment, <a href="https://finance.yahoo.com/news/exclusive-cvs-lays-out-20b-plan-to-modernize-us-consumer-healthcare-experience-154127371.html" target="_blank" title="Yahoo!Finance: Exclusive: CVS lays out $20B plan to modernize US consumer healthcare experience">Yahoo!Finance reported</a>, will impact more than CVS’ vertically integrated businesses like its pharmacy, Oak Street health providers and insurance arm Aetna. It also will allow competitors and other health sector players to plug into the CVS system.</p><p>Whether a retail business, even one as large as CVS Health, can deliver on the promise of getting the various parts of health tech systems to integrate effectively — and ideally through a single patient record — remains to be seen. And it should be noted that the report was scant on details about how CVS will achieve its vision.</p><p>But, if successful, CVS would accomplish something no other health care organization, governmental body or other entity has been able to achieve.</p><p>Tilak Mandadi, CVS Health’s chief experience and technology officer, previously held executive roles at Disney and American Express and will be leading the company’s efforts to achieve interoperability. Here are some key areas Mandadi says the company will be focused on:</p><h2>3 Key Goals CVS Health Hopes to Achieve</h2><h3><span>1</span> <span>|</span> Modernizing the Patient Dashboard</h3><p>The aim is to give physician offices and CVS pharmacies a complete picture of what is going on, rather than isolated events for an interaction such as a physician office visit or picking up a prescription.</p><h3><span>2</span> <span>|</span> Creating a More Proactive Communication System for Patients</h3><p>The goal will be to make it easier for consumers to get information about claims status and billing without burdening them to place follow-up calls for care or deciphering bills. For example, if a claim is being processed and a potential problem is flagged with the claim, the patient also would know rather than having to find out after it is adjudicated.</p><h3><span>3</span> <span>|</span> Developing Guardrails for Artificial Intelligence (AI)</h3><p>Mandadi notes that CVS will never use AI for clinical diagnosis or for prior authorization or claims denials, or to prevent human touch in the patient experience. The company does, however, use AI to streamline back-end functions like pharmacy voicemail processing.</p></div><div class="col-md-4"><p><a href="/center" title="Visit the AHA Center for Health Innovation landing page."><img src="/sites/default/files/inline-images/logo-aha-innovation-center-color-sm.jpg" data-entity-uuid="7ade6b12-de98-4d0b-965f-a7c99d9463c5" alt="AHA Center for Health Innovation logo" width="721" height="130" data-entity- type="file" class="align-center"></a></p><p><a href="/center/form/innovation-subscription"><img src="/sites/default/files/2019-04/Market_Scan_Call_Out_360x300.png" data-entity-uuid data-entity-type alt width="360" height="300"></a></p></div></div></div>.field_featured_image { position: absolute; overflow: hidden; clip: rect(0 0 0 0); height: 1px; width: 1px; margin: -1px; padding: 0; border: 0; } .featured-image{ position: absolute; overflow: hidden; clip: rect(0 0 0 0); height: 1px; width: 1px; margin: -1px; padding: 0; border: 0; } h2 { color: #9d2235; } Tue, 17 Jun 2025 06:00:00 -0500 Health Information Technology (HIT) /news/headline/2025-06-16-aha-responds-cms-astp-request-information-health-care-it-environment <p>The AHA June 16 <a href="/lettercomment/2025-06-16-aha-comments-cms-and-astponc-request-information-re-health-technology-ecosystem">responded</a> to a request for information on the health technology ecosystem from the Centers for Medicare & Medicaid Services and Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology. The AHA made several recommendations to improve health IT standards and infrastructure, increase access to effective digital health tools and advance data availability to improve health outcomes.  <br><br>The recommendations include continued development of ASTP/ONC’s United States Core Data for Interoperability vocabulary standards, collaboration across agencies to address broader infrastructure challenges associated with health IT adoption, repealing excessive information blocking disincentives finalized last year, building additional infrastructure to support the Trusted Exchange Framework and Common Agreement, and streamlining price transparency policies to remove complexity from the patient experience. </p> Mon, 16 Jun 2025 15:10:45 -0500 Health Information Technology (HIT) /news/headline/2025-05-13-administration-issues-rfi-health-technology <p>The Centers for Medicare & Medicaid Services and the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology May 13 issued a <a href="https://www.federalregister.gov/public-inspection/2025-08701/request-for-information-health-technology-ecosystem" target="_blank">request for information</a> on digital health products, the state of data interoperability and the broader national infrastructure for health technology. The RFI asks for input from patients, health care providers, technology developers, payers and other stakeholders on a range of topics, including how CMS and ASTP/ONC could help to drive greater adoption of digital health management and care navigation applications, identify barriers preventing the seamless exchange of health information across systems, reduce administrative burden and accelerate progress towards value-based care. The RFI also asks questions related to information blocking, price transparency, prior authorization and quality measurement policies. CMS and ASTP/ONC are accepting comments through June 16.</p> Tue, 13 May 2025 17:21:26 -0500 Health Information Technology (HIT) <div class="container"><div class="row"><div class="col-md-8"><p>The Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) Dec. 16 published a <a href="https://www.federalregister.gov/documents/2024/08/05/2024-14975/health-data-technology-and-interoperability-patient-engagement-information-sharing-and-public-health">final rule</a> implementing provisions related to the Trusted Exchange Framework and Common Agreement (TEFCA). The rule is intended to advance equity, innovation and interoperability by promoting the use and exchange of electronically captured health information as specified in certain provisions of the Health Information Technology for Economic and Clinical Health Act of 2009.</p><p>The final rule adds a new part — part 172 — to title 45 of the Code of Federal Regulations to implement certain provisions related to TEFCA. These provisions establish the qualifications necessary for an entity to receive and maintain designation as a Qualified Health Information Network (QHIN) capable of trusted exchange according to TEFCA. The final rule covers procedures governing QHINs including onboarding, designation, suspension and termination. The provisions this final rule adopts are not substantively different from those first proposed in August as part of the much larger <a href="https://www.federalregister.gov/documents/2024/08/05/2024-14975/health-data-technology-and-interoperability-patient-engagement-information-sharing-and-public-health">Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2)</a> rule and will be effective Jan. 15, 2025. Additional provisions of the HTI-2 rule, including Prior Authorization Application Programming Interfaces, more information blocking exceptions, United States Core Data for Interoperability Version 4 standards, and public health interoperability requirements are currently under review by the White House Office of Management and Budget and could be published in the future.</p><h2>AHA TAKE</h2><p>In our comments on the proposed rule, AHA supported the TEFCA objective of creating a common national framework that provides a universal technical foundation for interoperability. We also supported ONC’s proposed requirements for organizations choosing to participate in TEFCA as a QHIN. Specifically, we supported the recommendation that any organization aspiring to become a QHIN must adhere to specific privacy and security guidelines, with additional stipulations for those providing Individual Access Services.</p><p>However, we expressed concerns about what happens to the hospitals and health systems that rely on any QHIN that gets suspended or terminated from TEFCA. We appreciate that the ONC acknowledged our concerns in this area but are disappointed it declined to change the rule because the requested changes were deemed out of scope. We will continue to press this issue and encourage ONC to address it in future rulemaking. </p><p>Moreover, we also expressed concerns about the existing governance structure of TEFCA which gives QHINs the primary responsibility for ensuring that its participants abide by TEFCA’s requirements. We conveyed that this governance structure runs the risk of quickly exceeding the capabilities of both QHINs and the Recognized Coordinating Entity — the organization responsible for TEFCA’s oversite — of effectively managing participation in TEFCA. Although ONC did not change the proposed rule, the agency acknowledged these concerns and noted it “will continue to monitor TEFCA” and “will consider additional measures should circumstances arise that show that QHINs require additional oversight.”</p><h2>WHAT YOU CAN DO</h2><ul><li><strong>Share</strong> this advisory with your government relations, information systems and compliance teams to apprise them of this final rule.</li><li><strong>Contact </strong>the AHA with any questions or concerns regarding these provisions.</li><li><strong>Watch</strong> for notices of additional HTI-2 provisions published as final rules soon.</li></ul><h2>SUMMARY OF PROVISIONS</h2><ul type="disc"><li>Codifies (in new 45 CFR part 172) provisions related to TEFCA to provide greater process transparency and to further implement section 3001(c)(9) of the Public Health Service Act (PHSA), as added by the Cures Act.</li><li>Establishes the processes for an entity to qualify and maintain designation as a QHIN capable of trusted exchange under the Common Agreement.</li><li>Establishes the procedures governing the onboarding, suspension, termination and administrative appeals to the ONC for QHINs.</li><li>Codifies requirements related to QHIN attestation for the adoption of TEFCA. This subpart implements section 3001(c)(9)(D) of the PHSA and includes the requirement for ONC to publish a list on their website of the health information networks that have adopted the Common Agreement and are capable of trusted exchange pursuant to the Common Agreement.</li><li>Reenforces that adoption of TEFCA is voluntary. Section 3001(c)(9)(D)(ii) requires HHS to establish, through notice and comment rulemaking, a process for HINs that voluntarily elect to adopt TEFCA to attest to such adoption.</li><li>Finalizes the TEFCA Manner Exception, which allows an actor to limit electronic health information sharing requests to TEFCA only without being considered information blocking with no revisions.</li></ul><h2>FURTHER QUESTIONS</h2><p>If you have further questions, please contact Stephen Hughes, AHA’s director of health information technology policy, at <a href="mailto:Stephen.hughes@aha.org">Stephen.hughes@aha.org</a>.</p></div><div class="col-md-4"><a href="/system/files/media/file/2024/12/hhs-publishes-tefca-provisions-of-health-data-technology-and-interoperability-rule.pdf"><img src="/sites/default/files/inline-images/cover-hhs-publishes-tefca-provisions-of-health-data-technology-and-interoperability-rule.png" data-entity-uuid data-entity-type="file" alt="Regulatory Advisory Cover" width="679" height="878"></a></div></div></div> Thu, 19 Dec 2024 14:36:02 -0600 Health Information Technology (HIT) /news/headline/2024-12-16-hhs-releases-information-blocking-rule-related-care-access <p>The Department of Health and Human Services Dec. 16 published a <a href="https://www.federalregister.gov/public-inspection/2024-29683/health-data-technology-and-interoperability-protecting-care-access">final rule</a> implementing certain provisions related to information blocking exceptions. The rule revises defined terms related to protecting access to care for purposes of the information blocking regulations.<br><br>The agency adopted select provisions first proposed in August as part of the much larger <a href="https://www.federalregister.gov/documents/2024/08/05/2024-14975/health-data-technology-and-interoperability-patient-engagement-information-sharing-and-public-health">Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2)</a> rule. The adopted provisions are designed to address concerns from patients, health care providers and other stakeholders regarding patient privacy, access to care, preferences for electronic health information sharing, and methods for achieving a balance between certainty and flexibility for entities involved in enhancing EHI interoperability and exchange.The finalized “Protecting Care Access Exception” would allow entities to restrict EHI sharing under certain conditions to mitigate the risk of legal repercussions for patients, providers or care facilitators involved in lawful reproductive health services. The provisions will be effective immediately when published Dec. 17 in the Federal Register.<br><br>This is the second rule in less than a <a href="/news/headline/2024-12-11-hhs-releases-tefca-final-rule">week</a> containing policies originally included in the proposed HTI-2 rule. As such, additional provisions of the HTI-2 rule, including prior authorization application programming interfaces, United States Core Data for Interoperability Version 4 standards and public health interoperability requirements — which are currently under review by the White House Office of Management and Budget — could be published soon.</p> Mon, 16 Dec 2024 16:01:18 -0600 Health Information Technology (HIT) /amicus-brief/2024-09-24-amicus-brief-aha-electronic-health-record-association-support-pointclickcare-technologies-inc <p class="text-align-center">No. 24-1773<br><br>IN THE UNITED STATES COURT OF APPEALS<br>FOR THE FOURTH CIRCUIT<br> </p><p class="text-align-center">REAL TIME MEDICAL SYSTEMS, INC.,<br>                                         <em>  Plaintiff-Appellee,</em><br>v.<br>POINTCLICKCARE TECHNOLOGIES, INC. D/B/A POINTCLICKCARE,<br>                                        <em>      Defendant-Appellant.</em><br> </p><p class="text-align-center">On Appeal from the United States District Court for the<br>District of Maryland at Greenbelt<br> </p><p class="text-align-center">BRIEF FOR AMICI CURIAE ELECTRONIC HEALTH<br>RECORD ASSOCIATION AND AMERICAN HOSPITAL<br>ASSOCIATION IN SUPPORT OF DEFENDANT-<br>APPELLANT AND REVERSAL</p><table><tbody><tr><td><p>James E. Tysse<br>Kelly M. Cleary<br>Margaret O. Rusconi<br>Emily I. Gerry<br>Stephanie Ondroff<br>AKIN GUMP STRAUSS<br>HAUER & FELD LLP<br>2001 K Street N.W.<br>Washington, D.C. 20006<br>202-887-4000<br>jtysse@akingump.com<br> </p><p><em>Counsel for</em> Amici Curiae</p></td></tr></tbody></table> Tue, 24 Sep 2024 10:57:15 -0500 Health Information Technology (HIT) /news/headline/2024-09-17-hhs-awards-2-million-columbia-university-hospital-ohsu-responsible-ai-behavioral-health-it-projects <p>The Department of Health and Human Services Sept. 17 <a href="https://www.hhs.gov/about/news/2024/09/17/hhs-announces-2024-leap-health-awardees-focused-data-quality-responsible-ai-accelerating-adoption-behavioral-health.html" target="_blank">announced</a> it has awarded a total of $2 million to two recipients to create tools to improve care delivery, advance research capabilities and address emerging challenges related to interoperable health information technology. Columbia University Hospital in New York will be tasked with developing innovative ways to evaluate and improve the quality of health care data used by artificial intelligence tools. Oregon Health and Science University will work on advancing the adoption of health IT in behavioral health settings. The funds were awarded through HHS' Leading Edge Acceleration Projects in Health IT program.</p> Tue, 17 Sep 2024 15:25:44 -0500 Health Information Technology (HIT) <div class="container"><div class="row"><div class="col-md-8"><p>The Office of the National Coordinator for Health Information Technology (ONC), released the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) <a href="https://www.federalregister.gov/documents/2024/08/05/2024-14975/health-data-technology-and-interoperability-patient-engagement-information-sharing-and-public-health" target="_blank" title="The proposed rule text">proposed rule</a> for public comment. The HTI-2 proposed rule reflects ONC’s efforts to advance interoperability and improve information sharing among patients, providers, payers and public health authorities. Comments are due to the ONC by 5 p.m. ET, Oct. 4, 2024.</p><div class="panel module-typeC"><div class="panel-heading"><h2>Key Highlights</h2><p>The proposed rule would: </p><ul><li>Add technology and standards updates that build on the HTI-1 final rule, ranging from the capability to exchange clinical images (e.g., X-rays) to the addition of multi-factor authentication support.</li><li>Establish requirements for health IT that can be used by providers and payers to conduct streamlined electronic prior authorization.</li><li>Formally establish the Trusted Exchange Framework and Common Agreement (TEFCA) provisions in the Code of Federal Regulations.</li><li>Expand the list of Information Blocking Rule exceptions including one for the Protecting Care Access exception, to protect actors who withhold Electronic Health Information (EHI) in certain cases to reduce legal risks that may be associated with sharing EHI.</li><li>Require adoption by Jan. 1, 2028, of Version 4 of the United States Core Data for Interoperability (USCDI v4) certification criteria as the new baseline standard for EHI.</li></ul></div></div><h2>AHA TAKE</h2><p>The ONC intends for HTI-2 to advance public health interoperability, improve information sharing and support patient engagement. Much like its predecessor, HTI-1, the proposed rule predominately applies to health IT developers. However, hospitals and health systems will be affected by the updates in technology standards and other recommended changes. These updates should improve the accessibility and free exchange of clinical imaging data, such as X-rays and MRI results, and introduce reasonable security requirements, like multi-factor authentication and server encryption requirements for systems that handle electronic medical records. The AHA supports the security recommendations in the proposed rule that aligns with existing HIPAA Security Rule Safeguards and the Healthcare and Public Health Sector Cybersecurity Performance Goals. The AHA is also pleased the ONC is proposing to remove barriers to patient care and streamline the prior authorization process. It does so by supporting the technical requirements in CMS’s Interoperability and Prior Authorization final rule and requires payers to shift to electronic prior authorization. </p><p>The AHA is unclear, however, on what the ONC would accomplish with the other provisions in this proposed rule. The AHA is concerned about the TEFCA provisions because we have not seen widespread adoption of the framework by hospitals and health systems and it is not clear how adherence to the provisions will measurably improve patient access to care. Furthermore, the interaction of TEFCA with the rules on information blocking and the minimum-necessary requirement of HIPAA is unknown. These all require careful consideration of various legal, technical and privacy-related factors before TEFCA can be the accepted standard for clinical data sharing or a regulatory mandate for clinical data exchange. </p><p>Additionally, the AHA appreciates the ONC’s recognition of the complexity, safety issues and added work that arises from the manual processes required by hospitals and health systems to share information with public health authorities. However, the AHA questions whether the ONC has the authority to influence the way public health authorities manage and share electronic health records. Lastly, the AHA is disappointed that the ONC missed another opportunity to clearly define information blocking by offering specific examples and continues trying to define the rule by what it is not while just adding more exceptions. Although some of these new exceptions, such as broader definitions of “infeasibility,” could help protect providers from frivolous complaints, the other proposed exceptions are confusing, and their intended benefits are difficult to quantify. </p><h2>WHAT YOU CAN DO</h2><ul><li><strong>Share</strong> this advisory with your government relations, information systems and  compliance teams to apprise them of this proposed rule.</li><li><strong>Share</strong> any concerns and feedback on these provisions with the AHA.</li><li><strong>Submit</strong> by Oct. 4 to the ONC a comment letter explaining the rule’s impact on your hospital or health system.</li><li><strong>Watch</strong> for notice of a possible comment letter from the AHA on this topic.</li></ul><p>View the detailed Regulatory Advisory below.</p></div><div class="col-md-4"><p><a href="/system/files/media/file/2024/08/hhs-proposes-expansion-of-health-data-technology-and-interoperability-rule-advisory-8-15-2024.pdf" target="_blank" title="Download the Regulatory Advisory: HHS Proposes Expansion of Health Data, Technology and Interoperability Rule PDF."><img src="/sites/default/files/2024-08/cover-hhs-proposes-expansion-of-health-data-technology-and-interoperability-rule-advisory-8-15-2024-667px.png" data-entity-uuid data-entity-type="file" alt="Regulatory Advisory:HHS Proposes Expansion of Health Data, Technology and Interoperability Rule cover." width="NaN" height="NaN"></a></p></div></div></div> Thu, 15 Aug 2024 08:25:08 -0500 Health Information Technology (HIT) /news/headline/2024-07-10-hhs-releases-proposed-rule-designed-improve-patient-engagement-information-sharing-interoperability <p>The Department of Health and Human Services July 10 released a <a href="https://www.healthit.gov/sites/default/files/page/2024-07/ONC_HTI-2_Proposed_Rule.pdf">proposed rule</a> designed to improve health information sharing and interoperability. The Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule includes two sets of certification criteria designed to enable health information technology for public health and payers to be certified under the Office of the National Coordinator for Health Information Technology's Health IT Certification Program. The criteria would improve public health response, advance value-based care delivery and focus on standards-based application programming interfaces to improve end-to-end interoperability between health care providers and public health organizations or payers. <br><br>The rule proposes a new set of certification criteria to support the technical requirements included in the Centers for Medicare & Medicaid Services’ Jan. 2024 Interoperability and Prior Authorization <a href="https://www.govinfo.gov/content/pkg/FR-2024-02-08/pdf/2024-00895.pdf">final rule</a> to facilitate electronic prior authorization. The proposed rule also responds to patient, provider and other communities’ concerns about patient privacy and care access by expanding exceptions and clarifying the definitions of information blocking. HHS plans to publish the notice in the Federal Register with a 60-day comment period.</p> Wed, 10 Jul 2024 15:43:17 -0500 Health Information Technology (HIT) /legal-documents/2024-04-12-plaintiffs-reply-aha-v-rainer-case-april-11-2024 <p class="text-align-center"><strong>IN THE UNITED STATES DISTRICT COURT </strong><br><strong>FOR THE NORTHERN DISTRICT OF TEXAS</strong><br><strong>FORT WORTH DIVISION</strong></p><p>AMERICAN HOSPITAL ASSOCIATION, et al.,</p><p>                                     Plaintiffs,</p><p>v.                                                                              No. 4:23-cv-1110-P</p><p>BECERRA, et al., <br>                                    Defendants.<br><br> </p><p class="text-align-center"><strong>PLAINTIFFS’ COMBINED BRIEF IN OPPOSITION TO DEFENDANTS’ CROSS-MOTION FOR SUMMARY JUDGMENT AND REPLY BRIEF IN SUPPORT OF PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT</strong><br> </p><table><tbody><tr><td>Jonathan D. Guynn (TX 24120232)<br>JONES DAY<br>2727 N. Harwood St., Ste. 500<br>Dallas, Texas 75201<br>(214) 220-3939<br>(214) 969-5100 (fax)<br><a class="ck-anchor" href="mailto:jguynn@jonesday.com" id="mailto:jguynn@jonesday.com">jguynn@jonesday.com</a><br><br><br><br><br> </td><td>Hashim M. Mooppan* (DC 981758)<br>Rebekah B. Kcehowski* (PA 90219)<br>Audrey Beck* (DC 1739917)<br>JONES DAY<br>51 Louisiana Ave., N.W.<br>Washington, D.C. 20001<br>(202) 879-3939<br>(202) 626-1700 (fax)<br>hmmooppan@jonesday.com<br>rbkcehowski@jonesday.com<br>abeck@jonesday.com<br><em>* Pro hac vice</em></td></tr></tbody></table><p>                                  <em>    Counsel for Plaintiffs</em><br> </p> Fri, 12 Apr 2024 15:00:47 -0500 Health Information Technology (HIT)