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Federal Efforts to Modernize the Nation's Health IT Infrastructure

This Plan envisions the establishment of a responsive infrastructure that will enable person-centered health and health care goals, transform health care delivery and community health, and foster research, scientific knowledge, and innovation. These objectives set the purpose for improving the nation's health IT infrastructure to make it more inclusive, and to leverage both public and market-based solutions to make this infrastructure adaptable, so that it can both stimulate and keep pace with innovation.

To implement this Plan, the federal government has identified strategies that apply its most effective levers to drive change in the health environment and allow the government to prepare for emergent change from market and social sectors. Below are key federal initiatives that encompass multiple strategies to meet this Plan's mission and goals.

Defense Healthcare Management System Modernization Program (DHMSM)

DoD's military health system purchases or provides care to almost 10 million beneficiaries. The mission of the DHMSM program is to competitively acquire, test, deliver, and successfully transition to a state-of-the-market EHR system. Key to this modernization program is to engage the larger health IT marketplace to identify and implement a solution that provides best value and meets operational requirements. This approach allows the DoD to leverage the latest commercial technologies, improve usability, and save on costs.

In July 2015, DoD awarded a contract to modernize their EHR system. A key goal of the contract is to improve interoperability among the DoD, the VA and private sector health-care providers and enable each to access and update health records. Civilian health care organizations provide nearly 60 percent of health care for service members and their families. In addition to this contract, the VA and DoD spearhead numerous interagency data sharing activities and deliver IT solutions that improve the sharing of electronic health information. These IT solutions improve interoperability, improving care continuity and enhancing health care delivery to beneficiaries.

Finalize and Implement the Interoperability Roadmap

Secure, interoperable, and necessary health information technology is paramount to achieving this Plan's mission and vision. The significant progress achieved in health IT adoption has increased the demand to securely share health information electronically and use it to improve health and health care. Yet despite this progress, and for varied and complex reasons, significant challenges continue to limit the widespread and effective sharing of electronic health information across the care continuum.11

Interoperable health information and health IT solutions will lead to more efficient and effective health systems, better clinical decision support, scientific advancement, and a continuously learning health system.

Interoperable electronic exchange of health information allows individuals, providers, public health departments, researchers, and payers to securely find and use vital health information, enhancing care delivery, public health, and research, and empowering individuals to make informed choices regarding their health. Federal strategies center on creating an infrastructure that encourages interoperable health IT regardless of technology developer, platform, location, provider, policy, or other boundaries.

The Shared Nationwide Interoperability Roadmap, Draft Version 1.0 (Draft Roadmap) is a complementary planning document that proposes critical actions for both public and private stakeholders that will advance our nation towards an interoperable health IT ecosystem, advance research, and ultimately achieve a learning health system that efficiently and collectively improves health.

Whereas this Plan outlines federal efforts to focus on health IT beyond EHRs and health beyond health care, the Draft Roadmap details the interoperable infrastructure needed to support appropriate sharing and use of electronic health information toward achieving a learning health system. The Draft Roadmap is organized around five building blocks for a nationwide interoperable health information technology infrastructure:

This Draft Roadmap proposes critical actions that the public and private sector need to take to advance the country towards an interoperable health IT ecosystem over the next 10 years, identifying a path to achieving the vision in the three-, six- and ten-year time frames and a vision to catalyze collaboration and action across government, communities, and the private sector.

Protect the Privacy and Security of Health Information

As more health information transitions to electronic formats that are shared commonly, it is important that all stakeholders recognize their responsibility in protecting health information.13 The federal government plays a key role in promoting transparency in how health care organizations, companies, technology developers, and other entities obtain, manage, and retain such health information.

The government will provide oversight and guidance to encourage adherence to laws that protect the privacy and security of health information. The government's guidance should also help reduce misunderstanding and confusion of privacy and security laws that may dissuade parties from appropriate health information exchange.

It is important for individuals to understand what kinds of data are collected about them, who collects it, and how data will be used, shared, and disclosed, consistent with Fair Information Practice Principles.14 The federal government is committed to stimulating the development and use of policy, standards, and technology to advance individuals' rights to securely access, amend, and make choices for the disclosure of their electronic health information.

The federal government supports these developments to achieve two ends. First, the government should facilitate patients' ability to control the exchange of specific health information that many consider to be "sensitive" (which includes information related to substance use disorder treatment, reproductive health, mental health, domestic abuse, or HIV), in an electronic environment.

For example, using technology to document applicable permissions to access, use or disclose health information saves time and resources, and can build trust and confidence in the system overall.15 Second, such developments should support the availability of health information about individuals when and where they need it for treatment.

Federal Efforts on Cybersecurity

Recognizing that the national and economic security of the United States depends on the reliable functioning of critical infrastructure, in 2013, President Barack Obama issued Executive Order 13636, Improving Critical Infrastructure Cybersecurity. It directed the National Institute of Standards and Technology (NIST) to work with stakeholders to develop a voluntary framework - based on existing standards, guidelines, and practices - for reducing cyber risks to critical infrastructure.

This includes the integrated health IT infrastructure and the information and communications technology (ICT) infrastructure, necessary for health information interoperability, the advancement of a learning health system, and the Internet of Things (IoT). Further, in response to the Cybersecurity Enhancement Act of 2014, federal agencies are developing an updated federal cybersecurity research and development strategic plan. The strategic plan will be used to guide and coordinate federally funded cybersecurity research.

Additionally, the government will provide privacy and security (including health information breach prevention) educational material, based on federal or advisory group recommendations, to key stakeholders, including individuals. Security and the intrinsic value of health and other data are continually evolving, placing systems at increasing risk.

Maintaining and improving security of technology and information requires constant vigilance from all stakeholders. The federal government will continue to work internally and with external groups to help ensure that the nation's health IT infrastructure and information is secure.

The privacy and security of health information is important to the federal government, and the government will continue to pursue policies, levers, and enforcement mechanisms that engender confidence and trust for individuals and their families, caregivers, providers, and others.

Identify, Prioritize, and Advance Technical Standards

Health information is useful only if the end user can access and understand the information. Standards are the medium for individuals, health care entities, and public health agencies, health IT solutions, and medical devices to find, organize, exchange, secure, and share information. They must be maintained and progressively enhanced, based on feedback from real use, and need to accommodate emerging areas, such as using genomic data to achieve precision medicine and allowing integration of non-laboratory data into health records and research.

Use of common technical standards and specifications are necessary for electronic health information to move seamlessly and securely. Much of the content of clinical records - including laboratory test results, clinical measurements (e.g., blood pressure), test orders, medical problems, and drug names - is structured and susceptible to standardization.

However, some of the content - such as provider notes and other notations - may be more helpful as free text; health IT should aim to identify methods to capture and present this nonstandard information in more helpful ways that can improve the patient-provider encounter.

Using data elements consistently and reliably will allow for collecting information for individual health needs as well as for reuse of that information to drive decision support, quality measurement and reporting, population health management, public health, and research. Focusing on the highest priority standards can help accelerate their widespread adoption, allowing health IT to be more usable and efficient.

The ONC HIT Certification Program serves as a valuable mechanism for promoting the use of common standards for interoperability; however, significant work remains. To promote consistent standards implementation and reduce implementation variability, the federal government will continue to work with standards development organizations and industry stakeholders to assure users that newer versions of standards and implementation specifications more clearly describe discrete, germane requirements that are regularly evaluated and updated.

Initially, federal efforts will focus on efficiently addressing prioritized standards that enable sending, receiving, finding, and using a basic set of essential health information. ONC will continue to assess the ONC HIT Certification Program to ensure it can address and reinforce health IT applications and requirements that support federal value-based and alternative payment models.

Increasing User and Market Confidence in the Safety and Safe Use of Health IT

The technological marketplace has evolved, as providers and facilities become increasingly invested in the safety and safe use of a broad set of emergent technologies and solutions. Stakeholders are demanding ways to improve existing EHRs, use personal technology, such as smartphones and tablets, and integrate information from other technologies such as bedside infusion pumps, monitors, and ultrasound, so that technology and information safety and safe use is more seamless, user-friendly, and comprehensive.

Evidence suggests health IT improves patient safety; however, poor implementation or improper use of otherwise safe systems can lead to adverse outcomes.16

For the nation to collectively move to an expansive electronic health information environment, individuals, health care providers, and organizations need confidence that health IT solutions are secure, safe, and useful.

Food and Drug Administration's (FDA) Sentinel Initiative

Launched in 2008 by the Food and Drug Administration (FDA), the Sentinel Initiative aims to develop and implement a proactive system that will complement existing systems that the agency has in place to track reports of adverse events linked to the use of its regulated products. A national electronic system that will transform FDA's ability to track the safety of drugs, biologics, and medical devices once they reach the market is now being implemented. Monitoring the safety of its regulated products is a major part of FDA's mission to protect public health. The Sentinel System enables FDA to actively query diverse automated healthcare data holders-like EHRs, administrative and insurance claims databases, and registries-to evaluate possible medical product safety issues quickly and securely.

Individuals and providers must also have the ability to change health IT products, systems, or services without undue financial burden or the loss of valuable information. The implementation of this Plan, as well as the 2013 HHS Health IT Patient Safety Action and Surveillance Plan, will build and maintain confidence in the safety of the health IT solutions and support a competitive and innovative market.

Additionally, as part of the federal government's responsibility to protect the public's health and safety, a collaborative effort to design an appropriate, risk-based framework to assess regulation of medical devices and health IT resulted in a draft report as part of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). This framework will be applied as necessary as health IT progresses.

Advancing a National Communications Infrastructure

Telehealth is the use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration, and to promote individual self-management and well-being. Technologies include videoconferencing, social media and mobile applications, store-and-forward imaging, streaming media, and terrestrial and wireless communications.

A learning health system also incorporates advanced health models that increasingly leverage technology, such as telecommunications technology, to deliver health and clinical services remotely, and improve access to care across clinical and non-clinical community settings.

For example, remote monitoring can allow a care team to monitor an individual's health status while she is in the comfort of her home, improving the individual's care experience, or allow a rural hospital to expand its intensive care unit capacity through virtual providers. Mobile health apps can remind individuals to take medication or to access and contribute electronic health information to their health record, clinical registry, or other repositories. Telehealth can also expand access to care, allowing individuals to receive specialty care and improve convenience, such as for off-shore workers or home-bound care.

A strong national communications infrastructure is a prerequisite for sharing electronic health information among providers, individuals, and national emergency first responders, delivering telehealth and remote monitoring solutions, using mobile health applications, and performing highly complex research, business intelligence analyses, and other actions to transform clinical practice and improve health and community resilience.

Significant efforts are underway in both the public and private sectors to bring broadband internet services to all Americans. Maximizing availability of broadband services to all - including low income Americans, those in rural areas and tribal lands, and individuals with disabilities is a key national objective.17

Nevertheless, data shows that 55 million Americans - 17 percent of the population - lack access to advanced broadband services. There are also significant disparities in broadband access and use. More than half of the population in rural areas, and nearly two-thirds of the population in tribal areas lack access to advanced broadband services. Even in areas where broadband services are available, approximately 100 million Americans still do not subscribe.18

The inability among many to maintain a strong internet connection inhibits the sharing of high-quality data and graphics, such as medical images, and the ability to leverage video telecommunications needed for telehealth. As the government improves the communication infrastructure, it must retain sensitivity and responsiveness to individuals' technology literacy as well.

Broadband that Works

Building on the Federal Communications Commission's (FCC's) net neutrality plan, in 2015 the White House announced its plan to promote "Broadband that Works," a public-private effort to help more Americans, in more communities around the country, get access to fast and affordable broadband internet services. Efforts include (1) calling to end laws that harm broadband service competition; (2) expanding the National Movement of Local Leaders for Better Broadband; (3) launching a new initiative through the Department of Commerce, BroadbandUSA, to support community broadband services projects; (4) unveiling new grant and loan opportunities for rural providers through the Department of Agriculture; and (5) establishing a Broadband Opportunity Council to remove regulatory barriers and improve investment incentives.

Expanded, secure, and affordable high-speed wireless and broadband services, choice, and spectrum availability will support electronic health information sharing and use, support the communication required for care delivery, and support the continuity of health care and public health services during disasters and public health emergencies.

Collaborative Effort by All Stakeholders

The federal government plays three roles in coordinating its work with the private sector: contributor, beneficiary, and collaborator.19 By navigating the right balance among these three roles, federal agencies will promote a fertile and competitive marketplace ripe for innovation that advances this Plan's mission.

While protecting privacy, security, and confidentiality, the federal government is publishing new open data sources, converting existing data to electronic formats, requiring public access to data resulting from federally funded research, and making data easier to use via downloading, application programming interfaces, and access in the cloud.

The federal government aims to encourage private-sector innovators and entrepreneurs, as well as researchers, to use government and government-funded data to create useful applications, products, services, and features that help improve health and health care.

Patient-Centered Outcomes Research

Patient-centered outcomes research can help stakeholders make informed health decisions by increasing the quality and relevance of the evidence upon which those decisions are made. However, the time and expense of conducting high-quality research that produces definitive results present a key barrier to conducting needed research. Health IT can serve as a vehicle to facilitate more efficient research processes - particularly around the collection and use of research data.

HHS' Office of the Secretary receives funds transferred from the Patient-Centered Outcomes Research Trust Fund annually between 2011 and 2019 to build data capacity for patient-centered outcomes research, with a cumulative estimated total of over $140 million. The goal for these investments is to enable a comprehensive, interoperable, and sustainable data network infrastructure to collect, link, and analyze data from multiple sources to facilitate patient-centered outcomes research.

Federal efforts will also focus on improving accessibility, technical standards, services, policies, federal data, and governance structures that support person-centered outcomes research. This work will facilitate the progressive sophistication of a purposeful learning health system that allows providers, communities, and researchers to continuously learn and advance the goal of improved health and health care.

New capabilities will emerge that increasingly enhance research, allowing researchers to search and contribute data in new ways. Open data helps create opportunities for innovators to leverage the information to build, deploy, and scale solutions that help individuals, providers, and others improve health and care.

Beyond releasing data sets, the federal government funds innovative research for health IT products and solutions. The government also collaborates with standards development organizations to ensure that health IT products and solutions can use standards necessary to integrate and share clinical and person-generated health data across platforms and resources, ensuring interoperability and smooth information flow. Further, federal health systems can contribute organizational learning that leads to innovations in health IT usability and improved care delivery.

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