Legal Health Information Exchange - Legal issues relating to electronic health information exchange

Following ONC's release of its Program Information Notice "Privacy and Security Framework Requirements and Guidance for State Health Information Exchange Cooperative Agreement Program," (the P&S PIN discussed in a previous blog post) the National eHealth Collaborative (NeHC) has released a roadmap for successful and widespread growth of HIE to improve health and healthcare after extensive collaboration with private and public stakeholders (the HIE Roadmap). NeHC is a pubic-private partnership established through a grant from the ONC and is led by some of the nation's most respected thought leaders, and so we were thrilled to discover that our blog, Legal Health Information Exchange, was identified by NeHC as one of only a selected group of "Helpful Resources" found at Exhibit B of its HIE Roadmap. You can register with NeHC to download a copy of the HIE Roadmap here. 

Entitled "The Landscape and a Path Forward," the HIE Roadmap sets forth current HIE connectivity and exchange approaches across the nation, as well as federal efforts towards developing the foundation for interoperability and trusted HIE through common standards, services and policies.  It highlights those strategies for integrating these federal and private sector efforts, emphasizing the current progress that has been made and those challenges and barriers remaining to be overcome. 

Most importantly, it hopes to provide a roadmap of the major steps communities can follow to achieve progress towards HIE.  The HIE Roadmap states,

...Given the rapid market and policy changes and technology innovations occurring right now, there is confusion among healthcare stakeholders about how best to proceed with implementing HIE.  Leading HIE organizations are indeed charting new ground.  Emerging HIE efforts can and should learn from those who are further along in order to...leapfrog toward success."

It notes that in 2010, the number of public HIEs increased 81% from 37 to 67 with a whopping 210% increase in operating private HIEs, from 52 to 160.  Providing clear examples of leading HIE efforts, their leverage of national standards for exchange, and other factors contributing success, the HIE Roadmap seeks to capture the vision for why HIE is important to improving patient care and to the performance of our healthcare system, as well as provide a framework and a path forward for those working towards achieving HIE in their communities. 

The HIE Roadmap highlights several of the most notable challenges and barriers to HIE, including:

• Funding and sustainability;
• Variations in implementation of interoperability standards;
• Provider adoption;
• Disparate EMRs; and
• Privacy and security concerns.

However, it recognizes that these challenges and barriers are being "tackled and overcome."  The HIE Roadmap highlights ONC efforts towards building a foundation of interoperability and trusted exchange, in particular, recommendations of the HIT Policy and Standards Committees and their workgroups, such as the Meaningful Use, Information Exchange, and Privacy and Security Policy Workgroups.  It highlights the importance the Direct Project and the Nationwide Health Information Network (NHIN) continues to play in developing a strong interoperable foundation and the potential the Direct Project and NHIN have to promote best practices, compliance with existing national standards and implementation recommendations, and following through responsibility to protect health information.

The HIE Roadmap describes the approaches taken by several HIE initiatives across the nation, including:

• Care Connectivity Consortium, comprised of five leading health systems, Kaiser Permanent, Mayo Clinic, Geisinger Health, Intermountain Healthcare and Group Health;
• HealthBridge, with 50 participating hospitals, 800 physician practices, and 7,500 physicians;
• Indiana HIE (IHIE), with 90 hospitals and 19,000 participating physicians;
• Inland Northwest Health Services (INHS), with an air ambulance collaborative, rehabilitation hospital, and IT management for 38 hospitals and EMR services for 750 physicians, and which also partners with the Departments of Defense and Veterans Affairs; and
• Kaiser Permanente, which includes the Kaiser Foundation Health Plan and subsidiaries, 37 hospitals and over 450 clinical facilities, and the Permanente Medical Group Practices.

While highlighting the various strategies implemented by these initiative, the HIE Roadmap also recognizes that,

Indeed, interoperable HIE is a journey without a definite endpoint.  Many different approaches are being used, stakeholders are at different stages along this journey, and there is by no means a "one size fits all" model. 

It notes, however, that a key priority of many of these initiatives is to provide standards-based services to small physician practices, recognizing that most healthcare is delivered in these physician practices and the challenges they face.  Finally, the HIE Roadmap sets forth four major "steps" or phases for implementing successful and sustainable HIE, which starts wtih developing the HIE's objectives and vision.

In conclusion, the HIE Roadmap states,

The ultimate goal of HIE is to ensure that the right information is available at the right time and place every time to support the delivery of high quality, well coordinated, and cost effective patient-centered healthcare.  Keeping a consistent and clear focus on what is best for the patient is above all else the smartest way to stay on course in the ever-changing environment of HIE.

The Substance Abuse and Mental Health Services Administration (SAMHSA) announced last week that it will award up to $13.2 million in health information technology (HIT) grants for mental and behavioral health care settings.  These grants will further SAMHSA's strategic initiatives for HIT over the next years and contribute to the national goals set forth in the Federal Health IT Strategic Plan released by the Office of the National Coordinator (ONC) this September. 

SAMHSA Administrator Pamela S. Hyde stated,

Electronic health records improve quality, accountability, and cost effectiveness of health care services.  Persons with behavioral health problems often have significant physical health issues as well.  These grants are a critical down payment on the health information technology investment needed to ensure behavioral health service providers are fully interoperable with the general health system.

Among the awards are one-year $200,000 grants to 47 community health centers working to integrate primary care with behavioral health services.  A $3.8M grant award to the National Council on Community Behavioral Health Care was also announced to assist state and community health centers with implementing EHRs. 

Integrating behavioral health data with primary care data is critical to coordination of care.  The new grants will be instrumental in developing the much-needed HIT infrastructure necessary for the exchange of behavioral health information among providers and health care facilities.  SAMHSA is actively working with ONC to address policies and standards concerning the unique needs of behavioral HIT adoption and information exchange. 

For more information and the list of grant recipients, visit SAMHSA's official news release here.  

Prepared by Krystyna Nowik, Esq.

Last week, ONC opened a thirty-day window for organizations to apply to become the sole accrediting entity to oversee certifying organizations under the Permanent Certification Program for Health Information Technology (“Certification Program”). The Certification Program ensures certain electronic health record ("EHR") technology includes required capabilities for participation in the Medicare and Medicaid EHR Incentive Programs, which provide incentive payments to certain eligible health care professionals, hospitals and critical access hospitals that demonstrate meaningful use of certified EHR technology to adopt and utilize EHRs (“Meaningful Use”).

Currently, EHR vendors must be tested and certified by one of six ONC-approved entities (ONC-Authorized Testing and Certification Body or ONC-ATCB) under a temporary certification program implemented to ensure certified EHR technology was available for incentive payments beginning this year. Vendors who seek ONC-ATCB certification of their EHR technology as either a “Complete EHR" or an “EHR Module” must demonstrate compliance with certain capabilities, standards, implementation specifications and certification criteria. Once EHR technology has been ONC-ATCB certified, it can be used by health providers and hospitals to meet applicable meaningful use requirements. Complete EHRs provide all applicable certification criteria and the minimum capabilities a participant needs to comply with Meaningful Use. They may also include additional functions. EHR Modules, on the other hand, meet at least one, but not all, of the required certification criteria, and a combination of EHR Modules may be used to comply with Meaningful Use.

With the Final Rule for the Certification Program issued this January, accreditation and oversight is placed in the hands of the ONC Approved Accreditor or ONC-AA, which will be selected competitively every three years. The ONC-AA will be responsible for overseeing the ONC-ATCB entities and accrediting the Authorized Certified Bodies (ONC-ACB) under the Certification Program. Competing organizations for the ONC-AA will have to show what their proposed requirements would be for accrediting the ONC-ACBs, how surveillance of certified EHR technology would be conducted, their requirements for key personnel conducting the accreditation, and investigation and responding to complaints about ONC-ACBs. They also must show how they would adhere to ISO/IEC17011:2004 and experience with ISO/IEC Guide 65:1996, standards developed by the International Standardization Organization that specify general requirements for approving conformity assessment organizations and for product certifying organizations.

The ONC-ACBs replace the ONC-ATCBs created by the temporary certification program. Although ONC-ATCB status ends upon the sunset of the temporary certification program, certifications issued by ONC-ATCBs through the 2011/2012 payment years do not need to be re-certified for those years until ONC-ACB certification processes are in place.

The Notice for submission of requests for ONC-AA status may be found here.