Passing the Baton

At 12:00 noon on January 20, 2021, I became the National Coordinator for Health Information Technology of the US Department of Health and Human Services (HHS). At 12:00 noon on January 20, 2025, I will leave my role as the Assistant Secretary for Technology Policy and National Coordinator for Health Information Technology Policy of HHS. My 4 years in this job - leading a phenomenally talented and dedicated ASTP team, advancing HHS's technology strategy and policies to keep pace with the modern age, forging broader and deeper collaborations with our private industry partners, working arm-in-arm with our federal and state agency partners to make the best use of technology to advance their missions, opening more ways to securely and appropriately use data to improve patients' lives, and finally, serving the American people with every ounce of energy I could muster - has been an honor I never imagined I'd be so lucky to have. I'm forever grateful to President Biden, Secretary Becerra, and Deputy Secretary Palm for allowing me to serve my country in this way and for supporting me and ASTP in all of our efforts.

In 2004, President George W. Bush signed an executive order establishing the Office of the National Coordinator for Health IT and setting a target for the majority of Americans to have access to an EHR by 2014, a heady goal given that EHR adoption at the time was less than 10%. The 2008 ONC-Coordinated Federal Health Information Technology Strategic Plan set goals for adoption of health IT and nationwide network interoperability built on collaborative governance. In 2009 President Obama signed the HITECH Act, and the Meaningful Use program began in 2011, launching a public investment of over $35B in CMS incentives to spur adoption of EHRs. By 2014 over 95% of hospitals and over 75% of ambulatory physicians had adopted ONC-certified health IT systems, totally crushing President Bush's goal.

It was hard work by providers and technology vendors and government agencies, but it was a signature, generational achievement - in less than a decade, our country pivoted the most complex sector of the most complex economy in the history of the world from paper to bits and bytes. The actual work certainly wasn't pretty but it also wasn't atypical of most technology cycles - the apex of the "peak of inflated expectations" in 2013-2014 was followed by the nadir of the "trough of disillusionment" marked by the passage of the bipartisan 21st Century Cures Act in 2016, which gave specific direction to HHS to advance interoperability through Information Blocking policies, USCDI and FHIR API standards, and the Trusted Exchange Framework and Common Agreement (TEFCA) network.

As the dust was settling on EHR implementation, the industry was already starting to innovate on this newly laid digital foundation, and the Cures Act gave it a big boost up the "slope of enlightenment." Under the first Trump Administration, ONC (now ASTP) wrote the Cures Act Final Rule to implement the policies and standards called for in the statute, and also began building the TEFCA network by hiring a non-profit operating partner (The Sequoia Project) and convening stakeholders to draft network polices and agreements. Unfortunately, one of the many impacts of the COVID pandemic was that it stalled implementation of these important initiatives, while it also dramatically highlighted the urgent need for them.

It was my good fortune to take this job at this key inflection point, and from my first day I've tried to never lose of sight of the importance of the moment: It's time for the American people to get the ROI from the billions of public and private dollars invested to digitize our health care system by clearing the path for innovation that improves the quality, safety, efficiency, affordability, and equitability of health care.

By almost any measure, we've had a very productive four years and have made significant advances in standards and interoperability to improve the access, exchange, and use of health data, building on the work of previous administrations over the last 20 years. We've divided our work into three key areas:

• Keep building the digital foundation
• Make interoperability easy
• Accelerate effective and appropriate use of health data

Keep building the digital foundation

ONC certification of EHR products, established in the 2009 HITECH Act and now covering 97% of hospitals and almost 80% of ambulatory providers, plays a critical role in advancing our country's health innovation strategy. It helps to level the playing field for new entrants by requiring secure access to electronic data based on open-industry, non-proprietary, consensus standards, which allows innovators to scale novel products and services across an otherwise fragmented landscape of disparate EHR systems and health care entities. Indeed, in our draft HTI-2 rule, we worked with our agency partners to propose expanding the voluntary certification program to include payer and public health systems to better establish "paved pathways" for information exchange across the health care ecosystem.

On April 5, 2021, the Cures Act Final Rule went into effect. The rule set requirements for critical open-industry data and interoperability standards in certified EHR systems. The USCDI has become the de facto minimum standardized dataset of the healthcare system; it is required to be supported in EHR systems and available for exchange for use outside of the EHR, and is the basis for a growing number of federal programs and commercial applications. The USCDI is also a "rising floor" to assure that we keep moving ahead - for example, working with the FDA, we have included Unique Device Identifiers in the just released draft USCDI v6, which will support the need to exchange product, supply, and device data among health information systems to optimize patient safety, clinical care, research, and healthcare operations.

We soon became victims of our own success with the program, as demand quickly grew for more USCDI data elements. Fast on the heels of putting the USCDI into regulation, we launched the USCDI+ program to meet increasing requests from industry and federal agency partners to accelerate extensions of the USCDI for priority use cases such as cancer, behavioral health, quality, maternal health, and public health.

We also launched initiatives to help fill in the gaps for providers who didn't benefit from the MU incentives. With our partners at SAMHSA, we launched the Behavioral Health IT Initiative to provide resources and technical assistance for health IT adoption, and in support of the HHS Data Strategy, we are now leading the HHS Human Services Interoperability Strategy in collaboration with the Agency for Children and Families, the Agency for Community Living, and CMS.

Make interoperability easy

One of the biggest benefits of making data digital is being able to easily share and use it. We advanced this through promoting standardized mechanisms - data export standards and network architecture - to make data more available and consumable. We went much further though, and unlocked availability of all electronic health information, regardless of where it lives.

The Cures Act Rule laid down requirements for access to USCDI data through standardized means, but also introduced the Information Blocking provisions which opened a dramatically new frontier of information exchange. No longer would exchange requirements be restricted to a minimum dataset - we would now require that all electronic health information (EHI) be made available in whatever format it exists, in anticipation of the growth of innovative technologies that would be able to consume and process and distill value from this information.

• As of November 6, 2021, all providers, certified EHR vendors, and health information networks are required to make available all EHI in a machine-readable format to patients and authorized entities as allowed by law
• As of December 31, 2022, all certified EHR vendors must support the USCDI and make it available for exchange via standard CCDAs, FHIR APIs (individual and bulk queries, for B2C and B2B exchange), and other patient-facing technologies (e.g., patient portals)
• As of December 31, 2023, all certified EHR products must support EHI Export, which is the ability to export all EHI in an electronic and computable format for a single patient or a patient population. For the single patient, this capability is required to be available on-demand by the customer, i.e., without vendor assistance.
• As of August 1, 2024, all providers, certified EHR vendors, and health information networks are subject to enforcement actions by OIG if found to be in violation of Information Blocking regulations

Building on the FHIR enablement of certified EHR systems, our federal agency partners have advanced their embrace of FHIR in their mission and internal activities. CMS now requires FHIR-based approaches by regulated payers, HRSA has implemented FHIR-based reporting by federally-qualified health centers, and CDC is developing FHIR-based capabilities for public health. The Federal FHIR Action Plan is now helping to capture and guide this growing set of FHIR activities.

We recognize that it's a bewildering flurry of regulations, but it's all vitally important and is now in place. As the industry is starting to grasp the vast potential that these regulatory initiatives will catalyze, new opportunities are emerging for consumers to have on-demand, secure access to their own information via patient-focused technologies and services. Developers who base their products on the open-industry USCDI and FHIR API standards and follow the open pathways of the Information Blocking regulations should find fertile fields for creativity and innovation leveraging the platform capabilities required of certified EHR systems.

The push toward universal adoption of FHIR APIs is not just important for easier data access, it's a critical step toward moving our health care system from interoperability, the asynchronous exchange of static data and documents, to interactivity, the synchronous exchange of dynamic data to empower real-time workflows and automation. We take for granted having secure, tailored, transparent, real-time consumer experiences when we order food or clothing or rides on-line, and we should expect no less from our health care system.

While it's critical to open up data sharing at the sources, networks are critical to making interoperability scalable, reliable, secure, transparent, and efficient. While there are hundreds of clinical networks across the country, most are not connected with each other, which limits their usefulness and their ability to drive scale economies for lower unit costs. The 21st Century Cure Act directed ASTP to support development of a nationwide "network-of-networks" to connect existing and future networks using common nationwide policies and technical standards, much like private, independent, cell phone networks connect today allowing consumers to communicate with each other regardless of which network service or device they choose.

The Cures Act did not give ASTP authority to require participation in the Trusted Exchange Framework and Common Agreement (TEFCA), nor did it provide additional funding. As a result, TEFCA is a public-private collaboration facilitated by ASTP but driven by the voluntary participation and private funding of established participating networks (Qualified Health Information Networks or QHINs) and their participants. Building on the initial work started in the first Trump Administration, we updated the policies and added support for FHIR-based exchange and opened TEFCA for participation within a year, in January 2022. In December 2023, multiple QHINs went live on TEFCA.

In the ensuing year since go-live, considerable progress has been made. Participation now includes 6 designated QHINs, with another 2 candidate QHINs slated to go live early this year. In addition, Oracle Health has publicly announced its intent to become a QHIN.

The TEFCA "electronic phonebook" directory currently includes 15,000 clinical entities live for exchange including 700+ hospitals, 10,000+ physician offices, 50+ mental health centers, 400+ post-acute long-term care facilities, 40+ public health agencies, and almost 200,000 individual clinicians. Over the past year, these organizations have securely exchanged over 200 million searches for patient information to support clinical care, including almost 50 million searches in October 2024 alone. Some highlights from each QHIN include:

• CommonWell Health Alliance: Recently completed TEFCA gateway; a number of Athenahealth customers now live; Individual Access Service vendors in queue
• eClinicalWorks: Newly designated on January 17, 2025; planning 1000+ provider customers in 2025
• Health Gorilla: 100+ clinical entities live including hospitals (MEDITECH), rural acute and behavioral health (MEDHOST), nursing homes and home health agencies (ResMed)
• eHealth Exchange: Indian Health Service (federal agency provider organization), 2 HIEs, and Association of Public Health Laboratories (APHL); 4 HIEs currently in pre-go-live testing, 9 HIEs planning to join
• Epic Nexus: 600+ hospitals and 10,000+ clinics live; additional 200+ hospitals and 35,000+ clinics expected; in Dec 2024, Epic customers sent 860,000+ electronic case reports to public health agencies via TEFCA
• KONZA: 40+ health systems, 100+ hospitals, almost 800 physician clinics, 40+ Community Mental Health Centers, 37 Public Health Entities, and 5 Post Acute/Long Term Care Facilities; in next 6 months, expect to add two Individual Access Service and several HIEs
• MedAllies: In 2025 plan to add 1500+ providers (Veradigm) as well as other health care organizations and Individual Access Services vendors

In addition to implementation, key recent TEFCA developments include the further engagement of federal participants. The Indian Health Service is the first federal agency to join TEFCA, with additional HHS participation expected, and the Veterans Health Administration is committed and on track to join TEFCA in 2025.

Interoperability between payers and providers is critical to driving greater efficiency in our health care system. Health Care Operations use cases have been approved for TEFCA and a variety of payers, providers, and supporting vendors are engaging in "10×10" implementation activities including Blue Cross Blue Shield of Massachusetts, Elevance, Emory Healthcare, Epic, Humana, MEDITECH, Providence Health, and Tufts Medical Center.

Scaling FHIR-based exchange may be the biggest value of TEFCA in the future. FHIR APIs are already available in TEFCA for patient access, which will usher in new opportunities for innovators to offer patients valuable products and services to more directly manage their own care and wellness.

Making exchange easier is critical to expanding interoperability, but so too is enforcement of regulatory requirements. In 2021, ASTP created processes for receiving and reviewing complaints, of which we continue to receive about one per business day, and facilitated market transparency by publishing data on the complaints received. In collaboration with the Office of the Secretary, CMS, OIG, and the Departmental Appeals Board, ASTP coordinated the development and finalization of Appropriate Disincentives for providers found to be in violation of the Information Blocking rules, which is critically important for enforcement since the vast majority of complaints continue to be by patients against health care providers.

The Cures Act created a complex structure and process for determination and enforcement of the Information Blocking provisions, however, with the strong support of Secretary Becerra, the collaboration of our agency partners, and the tenacity of the ASTP staff, the pieces are now in place. As I noted in a previous blog, "it is behavior, rather than technology, that is far and away the biggest impediment to progress" in interoperability, and ASTP is taking proactive steps to monitor and enforce these Cures Act provisions.

Accelerate effective and responsible use of electronic health information

As health information becomes more liquid, it's necessary to ensure that protections are in place to ensure safe, secure, and responsible use of data. An important piece of HHS' commitment is to head off digital divides. Our health and the care we receive is often strongly determined by non-medical factors such as economic status, geographic location, living conditions, race, ethnicity, disability status, sexual orientation, and gender identity. We developed the concept of Health Equity by Design, a focus on including health equity at the outset as a key feature during the design, build, and implementation of health IT policies, programs, and workflows. The USCDI plays a key role in standardizing capture of health equity and social determinants of health factors that can significantly affect health care and well-being.

As we look forward, artificial intelligence (AI) and machine learning have the potential to revolutionize the way we structure and deliver, and indeed, the way we think about health care. In many ways, the work of the last decade to digitize our health care system was the prelude to this moment - AI will allow us to interpret and mobilize this rapidly mounting trove of electronic health information. Our country has spent over a decade first establishing a digital ecosystem and then making it available to better serve individuals and the overall health needs of our country. The next frontier is making all of that electronic information usable and useful - we're still mired in force-fitting digital tools into paper-based processes, but the power of AI-based reasoning engine technology, both large language and increasingly multi-modal models, will allow us to approach the world as true digital natives where we can connect the dots on an ever-expanding array of data and make sense of the over 90% of health information that is estimated to be largely unused today. Generative and agentic systems will help us identify ways in which we can fundamentally rethink what healthcare and well-being mean, allowing us to move beyond precision medicine to precision prevention and precision well-being.

ASTP issued ground-breaking regulations to advance the use of trustworthy AI in health care. As of January 1, 2025, all certified EHRs are required to make available a "nutrition label" of the AI-based technologies in their products to assist providers in determining the appropriateness of the tool in their setting. We hope that this focus on transparency will help to build confidence among patients and providers in AI-based technologies to advance their greater use across healthcare. More generally, the recently released HHS Artificial Intelligence Strategic Plan identifies opportunities for public-private partnership and HHS action to harness AI technologies to advance life sciences, health care, human services, and public health.

Passing the baton

I took this job hoping to invest in ASTP and help to "leave it better than I found it." At one of my first public speeches, I promised that, if nothing else, I would be impatient with the status quo and with our pace of change. I greatly appreciate everyone's patience with my impatience.

Over the last four years, I've worked to make an already responsive organization even more responsive to the concerns of patients, the industry, and our federal agency partners. We opened ourselves up to be better attuned to an industry undergoing dramatic and rapid change. Over the past four years, I spoke at 487 external events across the country, over half of them in person, to help communicate what we were thinking and doing, but more important, to listen.

We also internally reorganized ourselves to more directly serve our HHS sister agencies to use technology and data as a means for HHS to be more than the sum of its parts. As our digital health foundation rapidly expands, there is not a single mission area in HHS that doesn't now have to incorporate technology strategy in order to succeed. The establishment of Office of the Assistant Secretary for Technology Policy - consolidating department-wide coordination responsibilities in technology, data, and AI on the ONC chassis - recognizes the essential role that technology now plays in all aspects of the HHS mission.

It's a cavernous understatement to say that I'm inspired by the commitment and can-do attitude of the ASTP team, and deeply grateful for the deep collaborations we've built with our federal agency and industry partners over the last four years. Over the last 20 years, each person who has filled this role has picked up from where their predecessor left off and invested in the organization to make it better, because our work transcends individuals and administrations. I'm proud to have contributed to this legacy and it's with a profound sense of satisfaction that I leave knowing that ASTP's best days are still ahead.

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