On January 31, 2015, the Department of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) released a draft plan to require most healthcare providers (HCPs) to adopt interoperable electronic health care records (EHRs) by 2017.  The draft Roadmap titled  "Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Version 1.0" describes the Obama Administration's proposal to enable HCPs, patients, caregivers and others across the care continuum to access and share a common set of digital clinical and medical information about each individual patient at a nationwide level.1 To achieve this goal, the Roadmap outlines a plan for ensuring the interoperability of EHRs and the safe and secure exchange of patient health information. 

The draft Roadmap was announced on the heels of a January 23, 2015 public meeting on Health Information Technology (Health IT) sponsored by the Bipartisan Policy Center (BPC), a non-profit think tank that engages in advocacy and strategic outreach to suggest bipartisan legislative solutions to the nation's problems.  At the meeting, Congressional staffers representing both Democrat and Republican members of the Senate Finance Committee, and Health, Education, Labor, and Pensions (HELP) Committee, and the House Energy and Commerce Committee, articulated Congress's understanding of the need for greater clarity on Health IT regulation, including interoperability and Meaningful Use requirements.  Staffer panelists alluded to future initiatives to enhance interoperability, and speculated that the proposed Stage 3 Meaningful Use regulation would be highly focused on interoperability. 

While the draft Roadmap does not address issues such as meaningful use requirements specifically, it provides a set of basic requirements for interoperability that HCPs and software developers should be cognizant of and directs ONC to identify the best available standards for clinical interoperability.  It represents a preliminary step in implementing the joint ONC, Food and Drug Administration (FDA), and

Federal Communications Commission (FCC) interoperability recommendation contained in the April 2014 "Food and Drug Administration Safety and Innovation Act (FDASIA) Health IT Report."2

Impetus for the Draft Plan

Regulators and industry stakeholders recognize that the lack of coordination and information-sharing across a patient's care continuum is one of the primary contributors to patient injuries, increasing healthcare costs and poor quality of care.  As part of an ongoing department-wide effort to improve the nation's healthcare system, HHS is focusing its regulatory and strategic efforts on: (1) improving the way providers are paid; (2) improving and innovating in care delivery; and (3) sharing information more broadly to providers, consumers, and others to support better decisions while maintaining privacy.  The draft roadmap describes ONC's plans to achieve success in sharing information and interoperability and outlines a timeframe for implementation.

What is Device Interoperability?

In the context of Health IT, device interoperability means the electronic exchange of information between applications and across medical devices and electronic health records.  The risk-based Health IT framework envisioned by ONC and FDA is designed to promote interoperability and data sharing between Health IT products and across organizational boundaries.  Thus, the prioritization of standards-based interoperability regulation and coordination could provide the type of Health IT data sharing oversight and system reliability necessary for a safe and effective healthcare data delivery.

Key Tenets of the Roadmap and Plan

The draft Roadmap is based on five critical building blocks intended to support the business, policies and technical needs of nationwide interoperability:

  1. Rules of engagement and governance: ONC recognizes that in order to achieve interoperability, a common set of standards, services, policies and practices are needed.  However, this requires many actors to trust the practices of other people and organizations with whom electronic health information is shared.  The Roadmap indicates that HHS will engage public and private actors to create a multi-stakeholder governance landscape or "rules of the road."
  2. Supportive business, clinical, cultural and regulatory environments: The Roadmap notes that interoperability will not be achieved if use of EHR technology is dependent on the Medicare and Medicaid EHR incentive programs.  ONC recognizes that interoperability is reliant on a supportive business and regulatory environment, and an empowered patient base who demand interoperable health systems.  To achieve this, ONC again proposes to engage stakeholders and government officials to explore opportunities to accelerate interoperability and create a supportive business and regulatory environment together.  Additionally, providers, government, payers and Health IT developers must empower individuals to become active managers of their own health through mobile health, wearable devices and online services.
  3. Privacy and security protections for health information: ONC recognizes in the Roadmap that participation in and use of a learning health system is highly dependent upon reliable mechanisms to ensure that a secure network infrastructure is widely available, privacy is protected, health information and services are accessed only by verified individuals, and that users only have access to authorized data.  To that end privacy contracts, encryption and identity verification programs must be utilized on a broad scale.  Furthermore, HHS will work to create a regulatory scheme that harmonizes individual privacy rights with health information sharing.
  4. Certification and testing to support adoption and optimization of Health IT products and services: The Roadmap indicates a move towards certification of Health IT products and services that both tests and reviews product integrity and capabilities.  Although the Medicare and Medicaid EHR Incentive Programs already require the use of certified EHR technology, ONC seeks to create systems focused on interoperability.  Proposed Stage 3 Meaningful Use regulations for the Medicare and Medicaid programs, which is expected to be issued in early 2015, may focus on EHR interoperability.  If the Stage 3 Meaningful Use requirements include interoperability requirements, this will spur adoption across providers.  Once finalized, the Stage 3 Meaningful Use requirements will be effective in 2017.
  5. Core technical standards and functions:  In order to achieve interoperability, five core technical standards are necessary: (1) consistent vocabulary/terminology standards; (2) content and structure standards for different types of clinical workflow (e.g., electronic prescribing, specialist referrals); (3) consistent and vendor-neutral health information transport techniques; (4) security standards that are non-unique to health care but also meet minimum Health Insurance Portability and Accountability Act (HIPAA) privacy standards; and (5) standards for service used to connect different systems together.

2015 Standards Advisory and Health IT Grants

ONC's 2015 Interoperability Standards Advisory, published in conjunction with the Roadmap, provides the first glimpse of what recognized standards might look like.3 ONC's Standards Advisory provides a list of best available standards or implementation specifications for clinical health data interoperability that have been proposed or published.  While the current list does not cover all possible solutions and standards, nor does it even provide a definitive statement on the best interoperability standards, the annual advisory process does provide a regulatory consensus framework upon which industry can begin to rely.

The 2015 Standards Advisory is open for public comment through May 1, 2015.  As the first advisory in an anticipated annual series, significant comment on the process, format and individual standards are expected.  Consequently, the 2015 advisory may serve more as a guide of what to expect in the future as opposed to providing standards recommendations that can or should drive internal business decisions.  The Health IT industry will have wait for ONC and other regulators to review and respond to comments, and a true consensus document likely will not be issued until December 2015. 

On February 3, 2015, ONC also announced three funding opportunities, totaling $36 million, for grantees to accelerate the widespread adoption and use of Health IT.4 The grants will be divided among three separate programs and will focus heavily on advancing interoperability.  Along with the 2015

Interoperability Standards Advisory, these grants represent HHS's immediate dedication to implementing its interoperability roadmap and achieving nationwide Health IT standards and capabilities by 2017.