Beyond Compliance: How Standards Communities Shape Health IT Policy

Beyond Compliance: How Standards Communities Shape Health IT Policy

In this episode of The Dish on Health IT, Tony Schueth [https://www.linkedin.com/in/tony-schueth-a8141/], CEO of Point-of-Care Partners (POCP), welcomes Pooja Babbrah [https://www.linkedin.com/in/poojababbrah/], Executive Vice President of Strategy and Industry Alignment at NCPDP, and Anna Taylor [https://www.linkedin.com/in/annajumpin/], Associate Vice President of Population Health and Value-Based Care at MultiCare Health System and Steering Committee member of the HL7 Da Vinci Project, for a discussion on the relationship between standards development and policymaking.  Using the CMS “Interoperability Standards and Prior Authorization for Drugs” Proposed Rule (CMS-0062-P) as a backdrop, the conversation explores how standards communities, implementation accelerators, pilot programs, and industry collaboration influence healthcare interoperability long before requirements appear in federal regulations. Tony opens the discussion by asking how organizations should think about the relationship between standards development and policymaking today. Pooja and Anna explain that organizations such as the HL7 Da Vinci Project [https://confluence.hl7.org/spaces/DVP/pages/21857465/Da+Vinci?] and NCPDP Standards [https://standards.ncpdp.org/?] are often viewed as technical standards bodies, when in reality they serve as collaborative forums where providers, payers, vendors, pharmacists, regulators, and other stakeholders work through real-world operational challenges. The conversation then shifts to the value of participating early. Tony asks what organizations miss when they wait for final rules before becoming involved. Anna discusses the operational, strategic, and financial advantages organizations can gain by participating in standards development activities, implementation guide development, pilots, testing events, and implementation communities. As part of that discussion, Tony and Anna touch on the growing body of production implementations supported by Da Vinci. Organizations interested in understanding how these implementation guides are being deployed across the industry can explore the Da Vinci In-Action Implementation Tracker [https://confluence.hl7.org/spaces/DVP/pages/161057767/Da+Vinci+In+Action+Interactive+-+Implementations+To+Date?], which documents real-world adoption efforts and implementation progress. Pooja expands on the importance of creating opportunities for broader industry participation. She describes NCPDP Collab [https://www.ncpdp.org/collab.aspx?], an interactive forum open to both members and non-members that provides a venue for discussing workflow challenges, implementation barriers, and emerging industry needs before formal standards development begins. The discussion naturally progresses into the CMS “Interoperability Standards and Prior Authorization for Drugs” Proposed Rule (CMS-0062-P) [https://www.federalregister.gov/documents/2026/04/14/2026-07205/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-interoperability-standards?], which directly references standards and implementation approaches developed by both NCPDP and Da Vinci. As Tony guides the conversation toward implementation, Anna discusses how Da Vinci's collaborative testing model and initiatives such as Trebuchet [https://confluence.hl7.org/spaces/DVP/pages/234423487/Da+Vinci+Trebuchet+FHIR+Pilots/?] help organizations evaluate interoperability workflows in real-world settings before widespread adoption. The discussion then turns to one of the central themes of CMS-0062-P: the convergence of pharmacy and medical benefit workflows. Pooja explains that while patients and providers simply want access to treatment, healthcare organizations continue to operate within separate medical and pharmacy benefit structures. She argues that future interoperability efforts must focus less on the underlying standards and more on creating workflows that deliver a seamless experience for providers and patients regardless of where coverage resides. Building on that theme, Tony asks how healthcare organizations should think differently about workflow design. Drawing on her background in human factors engineering, Anna argues that healthcare has historically allowed technology to dictate workflows rather than designing technology around how people actually work. She advocates for starting with desired outcomes and user experience, then working backward to determine how standards, automation, and technology can support those goals. The conversation then moves to trust, adoption, and data quality. Tony observes that interoperability is no longer simply about moving data but about delivering the right information at the right time and within the right workflow. Anna discusses the importance of consistency and reliability in building trust, while Pooja shares examples of how incomplete implementations can undermine provider confidence even when standards and technology are technically available. Together, they argue that adoption depends as much on usability and trust as it does on technical capability. Returning to CMS-0062-P, Tony asks where organizations should focus their feedback beyond timelines and compliance concerns. Both guests encourage stakeholders to look closely at the broader strategic questions embedded throughout the proposed rule, particularly the requests for information that may signal future policy priorities. Rather than focusing solely on implementation challenges, they encourage organizations to use the comment process as an opportunity to help shape how healthcare workflows should function in the future. The episode concludes with Tony's signature question: what should healthcare stakeholders think differently about or start doing differently tomorrow? Pooja highlights the expanding role pharmacists can play in care coordination, medication management, and prior authorization workflows, arguing that pharmacists remain an underutilized resource within the healthcare ecosystem. Anna closes with a call for broader participation across healthcare, encouraging providers, employers, patients, vendors, and other stakeholders to engage with standards communities and implementation efforts. She emphasizes that meaningful progress happens when stakeholders move beyond identifying problems and actively participate in building solutions. Throughout the discussion, Tony reinforces a central theme: the future of healthcare interoperability is not being shaped solely through regulation. It is shaped through the collaboration, testing, implementation, and problem-solving taking place every day within standards organizations, implementation accelerators, pilot programs, and stakeholder communities. Organizations that want to influence the future of healthcare should not wait for final rules to arrive. They should participate in the conversations that help create them.

Interoperability as Infrastructure: Policy, Prior Authorization, and the Path Forward with ONC

In this episode of The Dish on Health IT, Tony Schueth [https://www.linkedin.com/in/tony-schueth-a8141/] is joined by Dr. Thomas Keane [https://www.linkedin.com/in/thomas-keane-b41a5012/], National Coordinator for Health IT at ONC [https://www.linkedin.com/company/office-of-the-national-coordinator-for-health-it/posts/?feedView=all], along with Alix Goss [https://www.linkedin.com/in/alexandra-alix-goss-7a04715/] and Janice Reese [https://www.linkedin.com/in/networkpdf/]. The conversation moves between policy, standards, and real-world implementation, with Tony often grounding the discussion in the practical friction points the industry continues to face. Tony opens by noting that “ONC is ONC again,” setting a lighter tone while also framing the broader conversation around where federal health IT policy is headed. He highlights Dr. Keane’s unusual background spanning engineering, clinical practice, and federal leadership, asking how that path shaped his perspective on impact. Dr. Keane explains that his transition into policy was driven by exposure and opportunity, but importantly, he continues to practice medicine. Tony picks up on that point, noting how rare it is for a National Coordinator to still be actively practicing, reinforcing the value of having a policy leader grounded in real-world care delivery. INTEROPERABILITY AT THE “SPEED OF TRUST” Tony then shifts the conversation to one of his core themes: interoperability as infrastructure. He references Dr. Keane’s framing of interoperability needing to operate at the “speed of trust,” and pushes on the tension between that vision and the reality of legacy systems still dominating the market. Dr. Keane responds by walking through ONC’s dual-track approach. On one hand, rulemaking like HTI-5 is pushing toward a FHIR-based, API-driven future. On the other, ONC recognizes that legacy standards are deeply embedded and must continue to be supported. He also points to the CMS Health Tech Ecosystem initiative as a powerful example of how government can accelerate progress by convening stakeholders rather than relying solely on regulation. Tony brings Janice Reese into the discussion to ground this vision in implementation reality. Janice emphasizes that the biggest barriers are not the APIs themselves, but the underlying trust infrastructure. She outlines identity, security, consent, and directory services as the key gaps preventing interoperability from scaling nationally. IMAGING AS A CASE STUDY IN MISALIGNED INCENTIVES Tony pivots to diagnostic imaging, framing it as a clear example where standards exist but adoption lags. He references the continued reliance on physical media like CDs and asks whether the issue is less about technology and more about incentives and certification. Dr. Keane agrees and shares a detailed example from his time as a radiologist, describing how consolidating imaging workflows improved efficiency and reduced turnaround times. He uses this to illustrate the broader point: the technology exists, but economic and operational incentives often work against seamless data exchange. He also notes that ONC’s recent RFI is intended to better understand these barriers and inform future rulemaking. Tony keeps the tone light with a quick aside about McDonald’s and queue efficiency, but uses it to reinforce a serious point. Even when better systems exist, organizations sometimes stick with less efficient models because they are familiar or expected. PRIOR AUTHORIZATION: PROGRESS, BUT STILL FRAGMENTED Tony then moves into prior authorization, referencing CMS-0057 and Da Vinci use cases as signs of progress, particularly on the medical side. He contrasts that with the ongoing fragmentation in pharmacy prior authorization and asks how ONC is thinking about bridging that gap. Dr. Keane emphasizes that standards alone are not enough. Real progress depends on making those standards usable in practice. He points to ongoing work with EHR vendors, PBMs, and intermediaries to ensure that real-time prescription benefit tools deliver complete and accurate information that clinicians can trust. Tony and Alix build on this by connecting real-time benefit checks to broader price transparency efforts, suggesting that combining these capabilities could fundamentally change how patients and providers make decisions together at the point of care.  PRICE TRANSPARENCY: STILL NOT PATIENT-FRIENDLY Tony directly challenges the current state of price transparency, asking how the industry moves beyond “check-the-box” compliance to delivering something that is actually usable for patients. Dr. Keane acknowledges that while progress has been made, much of the data remains too complex and not sufficiently tailored to individual patients. He notes that CMS continues to iterate on requirements, but that making cost information actionable at the point of care remains an ongoing challenge. AI: FROM HYPE TO REAL UTILITY Tony transitions to AI with a callback to a joke Dr. Keane made about AI either transforming healthcare or reducing it to three bullet points. He uses that setup to ask whether AI can realistically make complex healthcare data usable for patients and clinicians. Dr. Keane answers with a firm yes, pointing to existing use cases in radiology and clinical workflows where AI is already improving accuracy and efficiency. He shares examples of AI identifying stroke patterns, highlighting abnormalities in imaging, and even summarizing clinical reports. Tony then brings the conversation back to risk, asking about overreliance on AI and how policy should address bias and accountability. Dr. Keane is clear that responsibility still sits with the clinician, noting that physicians are trained to recognize bias and must independently validate AI-driven insights. Janice and Alix add that AI’s success ultimately depends on the quality and standardization of the underlying data. Without consistent, trusted data, AI will simply amplify existing gaps. INFORMATION BLOCKING AND ENFORCEMENT Tony closes the main discussion by turning to information blocking, asking what message ONC has for organizations that continue to restrict data access under the guise of technical or legal constraints. Dr. Keane outlines a range of enforcement mechanisms, from corrective action plans to potential financial penalties. He emphasizes that while ONC prefers to work with organizations to resolve issues, the expectation is clear: data must flow. FINAL CALL TO ACTION: DATA LIQUIDITY As always, Tony ends with a call-to-action question. If there were one thing the industry could do starting tomorrow, what would it be? Dr. Keane’s answer is direct: make data liquid. He ties this back to reducing administrative burden, improving price transparency, and enabling better patient decision-making. The goal is a system where data flows seamlessly, at the direction of the patient, to support care and operations. Janice and Alix close by reinforcing that the industry does not lack standards or policy direction. The real challenge is aligning stakeholders and scaling adoption.

HIMSS26 Recap: What You Need to Know

In this HIMSS26 [https://www.himssconference.com/] recap episode, Tony Schueth [https://www.linkedin.com/in/tony-schueth-a8141/] is joined by Brian Bamberger [https://www.linkedin.com/in/bamberger/], Vanessa Candelora [https://www.linkedin.com/in/vcandelora/], and Brian Dwyer [https://www.linkedin.com/in/brian-dwyer-a291191/] to unpack what they heard, saw, and debated after a week on the ground in Las Vegas. Rather than focusing on announcements or product launches, the conversation centers on the signals emerging across sessions, client meetings, and hallway conversations and what those signals suggest about where health IT is headed. The discussion opens with reflections on a keynote from former Tesla president Jon McNeill [https://en.wikipedia.org/wiki/Jon_McNeill], which challenged attendees to rethink entrenched healthcare processes. While initial skepticism about an outsider perspective was high, the panel agrees the message resonated. Meaningful progress may require stripping workflows down to their fundamentals and rebuilding them with simplicity in mind. That theme carries throughout the episode, particularly as the group connects it to persistent challenges like prior authorization and administrative burden. From there, the conversation shifts to the dominant presence of AI at HIMSS26. Unlike prior years, where AI often felt theoretical, the panel notes a clear shift toward practical applications embedded directly into workflows. Examples like prior authorization automation and clinical summarization highlight real efficiency gains, but the group is quick to point out that AI is only as good as the data behind it. Concerns around data quality, bias, and trust are no longer side conversations. They are central to whether AI can scale in meaningful ways. As one theme emerges repeatedly, it is that the industry may have rushed ahead with AI excitement before fully solving for foundational data challenges. That leads into a deeper discussion on interoperability. The panel describes a noticeable transition from “interoperability as a vision” to “interoperability as infrastructure.” Organizations are no longer asking what connected data exchange could look like. They are now actively building the components required to support it. This includes identity frameworks, consent models, trust networks, and governance structures. While progress is real, the work is also proving to be more complex than anticipated, with many stakeholders still grappling with how these pieces fit together at scale.  The conversation also explores how these shifts are playing out across different stakeholders. From a payer and vendor perspective, Dwyer highlights that many organizations have moved firmly into execution mode, particularly with regulatory deadlines like CMS-0057 on the horizon. However, there is still uncertainty about what comes next, especially when it comes to scaling beyond compliance into true business transformation. For life sciences, Bamberger notes that strategy is largely set, but execution remains uneven. Efforts are increasingly focused on improving data capture within EHRs, enabling more efficient prior authorization, and addressing complex use cases like rare disease diagnosis, where fragmented data can significantly delay care. Several moments in the discussion bring the conversation back to foundational issues that continue to slow progress. Patient identity, data quality, and structured versus unstructured data all emerge as persistent barriers. The group emphasizes that without resolving these challenges, even the most advanced AI tools will fall short. Initiatives like FHIR accelerators and broader industry collaborations are seen as critical to closing these gaps, but there is still work to be done to move from standards development to consistent, real-world implementation. The panel also spends time on emerging areas of focus, including price transparency and rural health transformation. Candelora shares observations from her HIMSS presentation, noting growing engagement and more nuanced questions from stakeholders, signaling that the industry is beginning to take these efforts more seriously. Meanwhile, rural health funding is creating both opportunity and urgency, with stakeholders recognizing that interoperability and data sharing will be essential to making those investments impactful within tight timelines. One of the more unexpected themes to surface is the human side of all this change. Despite the heavy focus on technology, many of the most meaningful conversations at HIMSS centered on workforce impact, trust, and the role of humans in an AI-enabled future. The panel reflects on the need for thoughtful change management, noting that adoption is not just about deploying new tools but building confidence in how they are used. There is a shared recognition that while AI will shift certain types of work, it will also require new roles, new skills, and a more intentional approach to integrating technology into care delivery. As the episode wraps, each participant highlights a key signal to watch over the next 12 to 18 months. Prior authorization is widely seen as approaching an inflection point, with tangible progress finally within reach, though not fully complete. At the same time, the convergence of interoperability, AI, and policy is identified as a broader, more transformative trend. This trend will shape how data flows, how workflows are designed, and ultimately how care is delivered. The takeaway is not that the industry has solved its biggest challenges, but that it is entering a new phase. The foundational pieces are being built, expectations are rising, and the focus is shifting from possibility to execution. The next chapter will depend less on vision and more on whether stakeholders can align, operationalize, and follow through on the work already in motion.

Modernizing Health IT: CMS Pledges, AI and the Trust Foundation with Amy Gleason

In this episode of The Dish on Health IT, host Tony Schueth [https://www.linkedin.com/in/tony-schueth-a8141/] is joined by co-host Alix Goss [https://www.linkedin.com/in/alexandra-alix-goss-7a04715/] and special guest Amy Gleason [https://www.linkedin.com/in/gleasonamy/], Strategic Advisor to Centers for Medicare & Medicaid Services (CMS) [https://www.linkedin.com/company/centers-for-medicare-&-medicaid-services/posts/?feedView=all] and Administrator of the U.S. Department of Government Efficiency (DOGE) Service [https://www.linkedin.com/company/department-of-government-efficiency/posts/?feedView=all], for a wide-ranging discussion on how health IT modernization is evolving under a pledge-driven, incentive-backed federal strategy. The conversation begins not with policy, but with lived experience. From Emergency Room to Interoperability Advocate Amy shares how her early career as an emergency room nurse exposed the dangers of fragmented information. Providers were expected to make critical decisions without access to complete patient histories, while patients, often in pain or distress, were unrealistically asked to recall complex medical details. That professional frustration became deeply personal when her daughter went more than a year without diagnosis for a rare autoimmune disease, juvenile dermatomyositis (JDM). Multiple specialists saw pieces of the puzzle, but no one could see the full picture across charts and settings. Amy reflects that if today’s AI tools had been applied to her daughter’s complete longitudinal record, the condition may have surfaced sooner. That experience shaped her philosophy. Technology must converge with policy and trust in ways that tangibly improve care. Why Pledges Instead of Rules? Tony presses on a central theme. Amy has argued that we cannot regulate our way to success. Why pursue voluntary pledges instead of federal rulemaking? Amy explains her frustration returning to government in 2025 to find interoperability policies she helped draft in 2020 still not fully effective until 2027. Seven years is an eternity in technology. Meanwhile, the industry had technically complied with numerous mandates including Meaningful Use, Cures Act APIs and CMS interoperability rules, yet many workflows still felt broken. In her view, regulation created a floor but not always real transformation. The CMS Health Tech Ecosystem Pledge [https://www.cms.gov/priorities/health-technology-ecosystem/overview] was launched as a different model. The federal government used its convening power to articulate a clear vision and challenge industry to deliver minimum viable products within six to twelve months rather than years. Initially announced with roughly 60 companies, the pledge initiative has grown to more than 600 participants collaborating in working groups. The three initial patient-focused use cases include: Improving data interoperability “Killing the clipboard” through digital identity and QR-based sharing Leveraging conversational AI and personalized recommendations for chronic conditions such as diabetes and obesity Amy describes live demonstrations at a Connectathon showing OAuth-enabled data retrieval, QR ingestion into EHR workflows and AI-powered recommendations built on patient data. The goal is not perfection by the first milestone, but real-world minimum viable functionality that can iteratively improve. Alix notes that from the standards community perspective, this approach feels aligned with long-standing calls for industry-driven collaboration, though it remains early to measure widespread impact. Carrots, Sticks and Rural Health The discussion turns to incentives. Amy outlines the administration’s carrots and sticks strategy: Stick: Enforcement of information blocking [https://healthit.gov/information-blocking/], with penalties up to $2 million per occurrence Carrots: Financial incentives such as the $50 billion Rural Health Transformation Program [https://www.cms.gov/priorities/rural-health-transformation-rht-program/overview] and the CMS ACCESS Model, [https://www.cms.gov/priorities/innovation/innovation-models/access] which pays for technology-enabled outcomes The Rural Health Transformation Program directs money to states with expectations that ecosystem-aligned interoperability and app participation be incorporated into funding proposals. CMS retains oversight and clawback authority to ensure funds support rural providers. The ACCESS Model represents a significant shift. Technology-enabled care platforms can register as Medicare Part B providers and be paid for measurable outcomes in tracks such as cardiometabolic disease, musculoskeletal conditions and behavioral health. Providers remain in the loop and receive compensation for referral and care plan oversight. Alix underscores that rural providers face steep financial and workforce constraints. Standards participation, implementation and technology upgrades require resources that are often scarce. The success of these incentives will depend on whether they reduce burden rather than add to it. AI: Evolution, Risk and Reality AI becomes a central thread of the episode. Amy compares AI adoption to autonomous vehicle models. Some scenarios allow tightly controlled automation, such as medication refills, while others require a human in the loop for higher-risk decisions. She points to a Utah prescription refill pilot as an example of bounded automation, where malpractice coverage and clearly defined use cases mitigate risk. When Tony asks who owns risk in this evolving landscape, Amy emphasizes the need for light but clear regulatory pathways rather than fragmented state-by-state oversight. Patients, she notes, are already there. Millions are asking health-related questions weekly through AI tools. The more pressing issue is ensuring those tools are grounded in structured medical data rather than incomplete memory or unverified inputs. She shares a striking story. Her daughter was excluded from a clinical trial due to a misclassification of ulcerative colitis. By uploading her records into an AI model, they identified a more precise diagnosis, microscopic lymphocytic colitis, which did not disqualify her from the trial. For Amy, this demonstrates both the power and inevitability of AI use. Alix adds caution. AI is only as strong as the data beneath it. Dirty, inconsistent and poorly structured data limits performance. Standards and terminologies remain essential to fuel high-fidelity models and safeguard trust. FHIR, Deregulation and the Data Foundation The conversation addresses an emerging tension. If regulatory burdens are being reduced, does that signal less need for structured standards like FHIR? Amy candidly admits she initially wondered whether AI might reduce the need for FHIR altogether. After discussions with labs and technologists, she concluded the opposite. Standardized data dramatically improves AI performance and reduces error. Deregulation is about removing unnecessary burden, not abandoning foundational data structures. Alix reinforces that FHIR enables discrete, normalized data capture that supports both legacy transactions and AI evolution. While future innovations may emerge, today FHIR remains the backbone for scalable interoperability. Prior Authorization and HIPAA Modernization The episode dives into prior authorization modernization across medical and pharmacy domains. Amy notes growing interest among pledge participants to expand into pharmacy prior authorization testing, diagnostic imaging, real-time benefit checks and bulk FHIR performance testing. Alix provides insight into ongoing work within the Designated Standards Maintenance Organizations to incorporate FHIR-based approaches into HIPAA-named standards [https://blog.pocp.com/blog/hipaa-a-consequential-shift-no-one-is-talking-about], particularly for prior authorization. She highlights testing beyond Connectathons, including implementer communities and real-world pilot efforts. Both stress the importance of public comment periods and industry engagement, describing participation as a civic responsibility for health IT professionals. Trust as the Core Enabler The final segment centers on trust. Amy explains that the ecosystem initiative aims to reinforce trust through: Stronger digital identity verification such as Clear, ID.me and Login.gov Certification frameworks such as CARIN and DIME for patient-facing apps A new national provider directory to replace fragmented provider data sources Transparency dashboards showing data requests, volumes and purpose Rather than replacing frameworks like TEFCA, she describes the pledge model as an accelerator layered above the regulatory floor. Transparency acts as sunlight, enabling visibility into who is accessing data and for what purpose. Final Takeaways In closing, Amy urges providers not to sit on the sidelines. Too often, she says, providers feel change is imposed on them. The pledge environment is designed as an open forum where they can directly shape what works or does not work in real workflows. Alix echoes the call. Standards require participation. Organizations must allocate budget and staff to engage, comment and collaborate. It truly takes a village. Tony concludes by framing the episode’s core message. Regulation establishes baseline expectations, but voluntary movements can demonstrate what is possible before mandates reach the Federal Register. Across pledges, payment reform, AI evolution and trust frameworks, the episode underscores a consistent theme. Modernization in health IT depends not only on policy direction, but on shared accountability and active participation from every stakeholder in the ecosystem. Listeners are reminded that POCP is available to support organizations in understanding the implications of federal initiatives, enforcement priorities and their strategic implications. Reach out to us [https://www.pocp.com/contact/] to set up an initial consultation.  The episode closes, as always, with the reminder that Health IT is a dish best served hot. Prefer video? Catch episodes on the POCP YouTube channel [https://www.youtube.com/@pocpHIT/playlists]

HTI-5 & Price Transparency Proposed Rules and Why Comment Periods Matter More Than You Think

In this episode of The Dish on Health IT, host Tony Schueth [https://www.linkedin.com/in/tony-schueth-a8141/], CEO of Point-of-Care Partners (POCP), is joined by colleagues Mary Griskewicz [https://www.linkedin.com/in/mary-griskewicz-ms-fhimss/], Regulatory Resource Center Lead, and Janice Reese [https://www.linkedin.com/in/networkpdf/], Senior Consultant and Program Manager of FHIR at Scale Taskforce (FAST), [https://www.linkedin.com/company/hl7-fhir-at-scale-taskforce-fast/?viewAsMember=true] for a wide-ranging discussion on two major proposed rules released in mid-December 2025: the HTI-5 proposed rule from the Assistant Secretary for Technology Policy (ASTP) and CMS’s latest proposal on healthcare price transparency. Rather than treating these rules as abstract policy exercises, the conversation focuses on what the government is trying to accomplish, how these proposals may reshape the interoperability and data access landscape, and why stakeholder participation during the comment period is not optional if the industry wants workable outcomes. Setting the Stage: How Proposed Rules Become Reality The episode opens with a level set for listeners who do not spend their days in the Federal Register. Mary walks through how proposed rules originate, typically from legislation or executive policy, and how they move from proposal to public comment to either a final rule, an interim final rule, or, in some cases, a complete pause or reset. She emphasizes a point that often gets overlooked: every public comment is read and reviewed. The agencies group and analyze the comments section by section and respond to themes and concerns in the final rule text. Janice builds on this by explaining that the comment period is where high-level policy intent meets operational reality. The most effective comments are not lengthy manifestos, but specific, experience-based feedback that highlights feasibility issues, sequencing challenges, and unintended consequences. HTI-5: From Experimentation to Execution The discussion then turns to HTI-5, with Mary outlining the core problem the rule is trying to address. Prior certification requirements placed a significant burden on vendors, often locking innovation into long development cycles while the market waited for updates. HTI-5 seeks to modernize this approach by reducing prescriptive certification requirements and relying more on modern, open architecture, particularly FHIR-based APIs, to enable faster, more scalable data exchange. Janice frames HTI-5 as a clear signal that the industry is moving out of the experimentation phase and into execution. By reinforcing a “FHIR-first” direction while pulling back on some certification detail, the rule implicitly raises expectations for real-world performance. As FHIR becomes the default, security, identity, consent, and trust cannot be treated as optional or inconsistently implemented components. From a FAST perspective, this shift is critical. HTI-5 creates the regulatory space, but the infrastructure and implementation guidance needed to make trusted interoperability work at scale must come from industry-led collaboration. Janice explains that FAST’s work on security, identity, consent, and national directory services is about operationalizing trust so organizations are not reinventing these foundations on their own. Information Blocking, Automation, and Trust at Scale A pivotal moment in the conversation centers on HTI-5’s clarification that information blocking explicitly includes automated and AI-driven access. Mary underscores that automation is now central to how data moves across the healthcare ecosystem. When access decisions are embedded in APIs, workflows, and algorithms, trust becomes the defining requirement. Janice expands on this by noting that the issue is not just whether data can be accessed, but whether access is appropriate, provable, and governed. As automation increases, expectations shift toward accountability, auditability, and consistent enforcement of identity and consent. FHIR APIs, once viewed as certification checkboxes, are becoming the primary channel for data exchange across networks, including consumer-facing applications. Stakeholder Impacts: Vendors, Providers, and Payers The episode then walks through how HTI-5 affects different stakeholder groups. For health IT vendors and digital health companies, Janice describes a trade-off: fewer certification guardrails provide flexibility but also remove a layer of protection. Vendors will be judged less on formal compliance artifacts and more on how their systems perform across networks at scale, including security, identity management, and reliability. Mary cautions that vendors should not interpret HTI-5 as traditional deregulation. With HTI-6 already on the horizon, organizations that underinvest now risk facing more stringent outcome-based expectations later. Tony reinforces this point, arguing that the real risk is collective. A single high-profile failure due to weak security or identity practices could undermine trust across the ecosystem and invite a regulatory response that affects everyone. For providers and health systems, the shift means becoming more informed consumers of technology. Certification alone will no longer guarantee interoperability or trustworthiness. Providers will increasingly need to ask vendors how solutions perform in environments beyond a single one and how identity, consent, and security are handled across organizational boundaries. From a payer perspective, Mary explains that while HTI-5 does not directly change prior authorization requirements, it fundamentally reshapes the data access environment. As FHIR APIs become the default, plans will be expected to exchange data more dynamically and through automated workflows. This raises expectations around timeliness, quality, and trust, and accelerates a shift from managing transactions to managing trust at scale. Price Transparency: Compliance Without Clarity The conversation then transitions to CMS’s proposed price transparency rule, with Tony noting the absence of POCP’s usual price transparency expert and setting expectations for a higher-level discussion. Mary explains that this tri-agency proposal builds on earlier rules by clarifying standards, easing some reporting burdens, and refining requirements around machine-readable files, metadata, and reporting timelines. While these changes offer some relief to plans, Janice highlights a deeper challenge. Making pricing data available does not make it meaningful. Without consistent ways to connect clinical concepts to billing codes and pricing structures, patients and employers are left with technically accurate but practically unusable information. True transparency will require better integration of pricing data into real-time workflows, supported by APIs, governance, and trust frameworks. Mary also reminds listeners that employers are a critical stakeholder often overlooked in these discussions. As purchasers of coverage, they rely on usable pricing data to understand utilization and manage costs, making their perspective essential during the comment period. The Closing Message: Comment, Participate, Get Involved The episode closes with a strong call to action. Mary urges listeners to “get off the bench” and engage, regardless of which rule is at issue. Comment periods directly affect compliance programs, product roadmaps, and competitive positioning. Janice reinforces that policy alone cannot solve interoperability challenges. Progress depends on shared implementation guidance, testing, governance, and sustained participation in standards organizations and multi-stakeholder initiatives, including FAST. The final takeaway is clear: HTI-5 and the price transparency proposal are not just regulatory events. They are inflection points. Organizations that participate now can help shape outcomes that are achievable, scalable, and trusted. Those that sit out will be left reacting to decisions made without their operational realities at the table. Listeners are reminded that both proposed rules have comment deadlines in late February, and that POCP is available to support organizations in understanding the implications and crafting effective comments. The episode closes, as always, with the reminder that Health IT is a dish best served hot.