1. Overview of ONC Report to Congress on Health Information Blocking Presented to the Health IT Policy Committee, Task Force on Clinical, Technical, Organizational, and Financial Barriers to Interoperability Karson Mahler, J.D. Office of Policy, Office of the National Coordinator for Health IT Friday, September 25, 2015

2. Overview of Report to Congress 1 On April 10, 2015, ONC responded to Congress’s request for a Report to Congress on Health Information BlockingReport to Congress on Health Information Blocking First in-depth analysis of nature and extent of information blocking Defines information blocking in a fair and practical way Surveys available evidence and knowledge Details current and proposed actions Describes gaps in current knowledge, programs, and authorities

3. Key Findings and Recommendations

4. Nature and Extent of the Problem Evidence of Information Blocking: – Unsolicited complaints (60+ in 2014) – Additional anecdotes and reports – Extensive discussions with stakeholders – Public records and testimony – Economic research – Accumulated knowledge and experience of ONC staff While the evidence is limited in some respects, it is clear that information blocking is occurring and is a serious problem. 3

5. What is Information Blocking? Information blocking occurs when persons or entities knowingly and unreasonably interfere with the exchange or use of electronic health information. Three elements: 1.There is an act or course of conduct that interferes with the ability to exchange or use electronic health information (where permitted/authorized). 2.The actor knows or should know that his/her actions are likely to cause such interference. 3.Under the circumstances, there is no reasonable justification for engaging in the act or course of conduct. 4

6. Focus on Objectively Unreasonable Conduct Touchstone: Conduct must be objectively unreasonable. – What is the reason for the conduct? – What is its likely impact (e.g., on individuals’ access to PHI or on providers’ access to information for treatment, care coordination, population management, etc.) – Could it be reasonably avoided? – Is it necessary to comply with privacy or other laws? – Is it necessary to advance other countervailing interests? See Appendix A of the Report to Congress for detailed scenarios and analysis. 5

7. Practices that Raise Serious Information Blocking Concerns Certain practices are inherently likely to raise serious information blocking concerns. – Contractual or other restrictions on information sharing, especially individuals’ access to PHI and providers’ exchange and use of core clinical data for patient care. – Opportunistic pricing for information exchange, data export/portability, interfaces, etc. – Use of non-standard technologies or approaches that raise the cost, complexity, or burden of exchanging information, when relevant standards have been adopted by the Secretary. – Practices that are likely to “lock in” users or information; lead to fraud, waste, or abuse; or impede competition and innovation. 6

8. Need for a Comprehensive Approach Information blocking can be most effectively addressed through a comprehensive approach comprising: – Targeted actions to deter and remedy information blocking; and – Broader strategies to address the larger context in which information blocking occurs. An effective strategy will require overcoming gaps in current knowledge, programs, and authorities. 7

9. Targeted Actions Strengthen in-the-field surveillance of health IT certified by ONC Constrain standards and implementation specifications for certified health IT Promote transparency in certified health IT products and services Establish governance rules that deter information blocking Work in concert with HHS Office for Civil Rights (OCR) to improve stakeholder understanding of the HIPAA Standards related to information sharing Coordinate with the HHS Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) concerning information blocking in the context of the federal Anti-Kickback Statute and Physician Self-referral Law Refer illegal business practices to appropriate law enforcement agencies Work with CMS to coordinate health care payment incentives and leverage other market drivers to reward interoperability and exchange and discourage information blocking Promote competition and innovation in health IT and health care 8

10. Broader Strategies Many actions that do not meet the criteria for information blocking still interfere with the effective exchange and use of electronic health information. In addition, a variety of systemic barriers to interoperability and health information exchange also impede progress towards more meaningful information sharing. The draft Shared Nationwide Interoperability Roadmap 2 represents ONC’s continued commitment to understanding and overcoming these complex challenges, together with industry, government, and the health IT community.Shared Nationwide Interoperability Roadmap Continuing to address and solve these challenges will be among the most important actions the federal government can take to help prevent information blocking and ensure that the nation’s health IT and health care vision is fulfilled. 9

11. Gaps in Knowledge, Programs, and Authorities Limited evidence and knowledge of information blocking Limitations of certification for addressing information blocking by developers Limitations of program oversight for addressing information blocking by providers Inadequate legal protections and enforcement mechanisms for information blocking Lack of transparency and information about health IT products and services Need for an effective governance mechanism for nationwide health information interoperability 10

12. Resources Report to Congress on Health Information Blocking (April 2015) – Available at: http://www.healthit.gov/sites/default/files/reports/info_blocking_040 915.pdf http://www.healthit.gov/sites/default/files/reports/info_blocking_040 915.pdf Complaints : – Complaints of information blocking can be submitted to ONC via the complaint form at http://www.healthIT.gov/healthITcomplaints or by email at healthITcomplaints@hhs.gov.http://www.healthIT.gov/healthITcomplaintshealthITcomplaints@hhs.gov 11