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Exceptions to Information Blocking Defined in Proposed Rule: Here’s What You Need to Know

Information blocking practices inhibit care coordination, interoperability, and healthcare’s forward progress.  The ONC’s proposed rule ushers in the next phase of the Cures Act by defining information blocking practices and allowed exceptions. To make the final rule as strong as possible, exceptions should be narrowly defined. In proposed form these include the following:

Preventing Harm.
Promoting the Privacy of EHI.
Promoting the Security of EHI.
Recovering Costs Reasonably Incurred.
Responding to Request that are Infeasible.
Licensing of Interoperability Elements on Reasonable and Non-discriminatory Terms.
Maintaining and Improving Health IT Performance.

This article covers each of these exceptions and discusses what to watch for in the final version of the rule.

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Exceptions to Information Blocking Defined in Proposed Rule: Here’s What You Need to Know

  1. 1. Exceptions to Information Blocking Defined in Proposed Rule: Here’s What You Need to Know
  2. 2. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. The Office of the National Coordinator for Health Information Technology (ONC) recently released a proposed rule to implement provisions in the 21st Century Cures Act. The Cures Act was signed into law in December 2016 and introduced sweeping healthcare legislation and funding for medical research, drug development, and medical device innovation. The ONC’s long-awaited proposed rule ushers in the next phase of the Cures Act by adding substance to these provisions. The Cures Act Becomes Law
  3. 3. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. The proposed rule was released in March 2019 and provides for a public comment period that expires on June 3, 2019. Following the public comment period, ONC will review feedback and eventually release the final rule, which could take another one to two years. According to the U.S. Department of Health and Human Services (HHS), the proposed rule: …is designed to increase innovation and competition by giving patients and their healthcare providers secure access to health information and new tools, allowing for more choice in care and treatment.” The Cures Act Becomes Law
  4. 4. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. In its promotion of access, exchange, and use of electronic health information (EHI), the proposed rule outlines seven exceptions to information blocking. It’s important for healthcare providers, healthcare systems, and vendors that are interested in promoting information sharing to review these exceptions during the public comment period to help ensure that they are sufficiently restrictive in the final rule. The Cures Act Becomes Law
  5. 5. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. The introduction of the Health Information Technology for Economic and Clinical Health (HITECH) HITECH Act, provided federal subsidies for the adoption of EHRs. Although the legislation required that EHRs have interoperability functionality, it was less successful in promoting interoperability in practice. Further, the HITECH Act did not anticipate the extent to which widespread information blocking practices would limit interoperability. The Cures Act Becomes Law
  6. 6. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. Now that most healthcare organizations have adopted EHRs, much of this information is siloed and can be difficult to get the right information at the point of care. Siloed information also inhibits the ability to analyze data that can improve care delivery and financial and operational processes. The promise of vast amounts of health information can’t be realized until interoperability improves. The Cures Act Becomes Law
  7. 7. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. One reason better interoperability does not exist is simply that it can be difficult to get different systems to communicate with one another effectively. However, this is also due to information blocking practices. Information blocking practices may be based on organizational policy or they may be technical. The Cures Act Becomes Law
  8. 8. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. Examples of organizational policy are: The Cures Act Becomes Law Taking the position that data models or schemas are proprietary, even though it has been long established that data compilations are not protected by copyright or other intellectual property laws. Claiming that sharing EHI for treatment with a third-party provider is prohibited by HIPAA, when it is not.
  9. 9. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. An example of technical information blocking is not making application programming interfaces (APIs) readily available. Whether intentional or not, information blocking practices can inhibit the sharing of critical healthcare information, with a range of negative consequences including: • Failure to coordinate care. • Unavailability of important clinical values at the point of care. • A lack of the rich data needed to fully utilize analytic tools, benchmarking, and machine learning techniques. The Cures Act Becomes Law
  10. 10. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. Following from the definition in the Cures Act, the proposed rule defines information blocking as: The Seven Proposed Exceptions to Limiting Information Blocking …a practice that, except as required by law or covered by an exception…is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.” The Cures Act stipulates fines for information blocking up to $1,000,000 per violation. The proposed rule includes seven proposed exceptions to information blocking which, if the required elements of the relevant exception are met would exempt the practice from enforcement.
  11. 11. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. These seven exceptions are: 1. Preventing harm 2. Promoting the Privacy of EHI 3. Promoting the Security of EHI 4. Recovering Costs Reasonably Incurred 5. Responding to Request that are Infeasible 6. Licensing of Interoperability Elements on Reasonable and Non-discriminatory Terms 7. Maintaining and Improving Health IT Performance The Seven Proposed Exceptions to Limiting Information Blocking
  12. 12. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. 1: Preventing Harm The Seven Proposed Exceptions to Limiting Information Blocking An organization may engage in a practice that is reasonable and necessary to prevent physical harm to a patient or other person. The organization must have a reasonable basis to believe that its practice will directly and substantially reduce the likelihood of harm to a patient. The organization must have adopted a policy that addresses patient harm or make case by case findings that a disclosure of EHI could result in patient harm.
  13. 13. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. 2: Promoting the Privacy of EHI The Seven Proposed Exceptions to Limiting Information Blocking An organization may engage in a practice to protect the privacy of EHI. The organization must demonstrate a basis for its actions in HIPAA and other privacy laws.
  14. 14. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. 3: Promoting the Security of EHI The Seven Proposed Exceptions to Limiting Information Blocking An organization may implement measures to protect the security of EHI. The practices must be narrowly tailored to the measures necessary to protect security.
  15. 15. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. 5: Responding to Request that are Infeasible The Seven Proposed Exceptions to Limiting Information Blocking An organization is permitted to decline a request for EHI access if it determines, using objective and verifiable criteria consistently applied, that the request is infeasible.
  16. 16. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. 6: Licensing of Interoperability Elements on Reasonable and Non-discriminatory Terms The Seven Proposed Exceptions to Limiting Information Blocking An organization may claim that its technology or processes are protected by IP law, however, the organization has an obligation to offer a license to the technology or processes on reasonable and non-discriminatory terms.
  17. 17. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. 7: Maintaining and Improving Health IT Performance The Seven Proposed Exceptions to Limiting Information Blocking Allows for downtime that may make health IT and EHI temporarily unavailable in order to perform maintenance or upgrades.
  18. 18. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. The Seven Proposed Exceptions to Limiting Information Blocking A consistent theme that runs through the exceptions that the organization’s practices must be reasonable and non-discriminatory and must be consistently applied. Health Catalyst generally views each of these exceptions to be well-defined and sufficiently narrow. However, there are some aspects of the exceptions that should be modified to ensure that there are no major loopholes that would continue to encourage information blocking practices.
  19. 19. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. Licensing of Interoperability Elements on Reasonable and Non-discriminatory Terms The Good This exception addresses a problem that many data and analytics vendors encounter when working with some vendors or healthcare providers. When asked for access to a database, a vendor or healthcare provider may claim that providing access to data will infringe its intellectual property rights.
  20. 20. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. Licensing of Interoperability Elements on Reasonable and Non-discriminatory Terms The Good The exception would create an obligation for the party receiving the request to respond to the requestor within 10 business days, and to offer a license to any technology or processes on reasonable and non-discriminatory terms, and at a reasonable cost. The language on reasonable cost is helpful because it could help to limit the practice of vendors charging prohibitive fees for access.
  21. 21. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. An organization could use one or more of the exceptions to justify information blocking practices, and it could be difficult to challenge this use of the exceptions. These exceptions include: Privacy and Security Exceptions Responding to Requests That Are Infeasible What to Watch Out For > >
  22. 22. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. Privacy and Security Exceptions What to Watch Out For These exceptions are drafted quite broadly. A healthcare provider or vendor could claim that it does not intend to share EHI in order to comply with the HIPAA privacy or security standards. While the claim must be backed up, in practice it may be very difficult to challenge this position.
  23. 23. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. Privacy and Security Exceptions What to Watch Out For Attempts to “litigate” the issue, whether in the figurative sense of challenging the basis for an unreasonable determination, or filing an information blocking complaint, may be too time-consuming, costly, and ultimately be ineffective. There is also the possibility that an organization would “comply” with the rule by delivering low quality information to providers, and this type of behavior could also be difficult to challenge.
  24. 24. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. Responding to Requests That Are Infeasible What to Watch Out For This is another exception that could be misused because of its potentially broad scope. The exception states: …an actor must demonstrate that complying with a request to access, exchange, or use EHI would impose a substantial burden on the actor that is unreasonable under the circumstances.”
  25. 25. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. Responding to Requests That Are Infeasible What to Watch Out For Although proving that a request poses a substantial burden takes into account several factors, such as: • Cost to comply • Type of information • Financial resources • Technical resources
  26. 26. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. Responding to Requests That Are Infeasible What to Watch Out For These findings may prove very difficult to challenge, opening the door to misuse and continued information blocking. One of these factors is that the party must provide “comparable access,” but this could open the door to providing access that on its face appears comparable but in practice lacks granularity, speed, or other attributes that would make the EHI useful. Reasonable cost provisions could be watered down in the final rule and open the door for continued prohibitive charges for access.
  27. 27. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. Overall, the proposed rule is a very positive development for promoting interoperability, with strong, narrowly defined exceptions to limit information blocking practices. If the proposed rule is implemented substantially in its current form, it should reduce information blocking and promote interoperability. Why This Matters
  28. 28. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. However, there is still a risk that industry groups will try to delay or dilute the proposed rule. The proposed rule has already been delayed–more than two years–and it will still take another one to two years for the final rule to go into effect. Healthcare providers, healthcare systems, and healthcare IT vendors should all care about this rule being implemented in its strongest possible form. Why This Matters
  29. 29. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. Reducing information blocking will help healthcare providers and systems leverage technology and services to improve processes and patient care, and financial and operational processes. It will help healthcare IT vendors by allowing them to innovate in faster cycles to develop and deploy those technologies and services. Some vendors have profited from information blocking and siloed data in order to gain market share and increase the barrier of entry to others, but these practices ultimately harm the healthcare system and patient care. Why This Matters
  30. 30. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. For more information: “This book is a fantastic piece of work” – Robert Lindeman MD, FAAP, Chief Physician Quality Officer
  31. 31. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. More about this topic Link to original article for a more in-depth discussion. Exceptions to Information Blocking Defined in Proposed Rule: Here’s What You Need to Know How Healthcare Text Analytics and Machine Learning Work Together to Improve Patient Outcomes Mike Dow; Levi Thatcher EHR Integration: Achieving this Digital Health Imperative Daniel Orenstein, JD, General Counsel Four Critical Phases for Effective Healthcare Data Governance Health Catalyst Editors Six Challenges to Becoming a Data-Driven Payer Organization Luke Skelley, Sales, VP; Matt Denison, Payer Solutions, VP; Rob McCrory, Strategic Advisor Clinical Data Management: 3 Improvement Strategies Jane Felmlee , Finance Operations Consultant
  32. 32. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. Other Clinical Quality Improvement Resources Click to read additional information at www.healthcatalyst.com Prior to joining Health Catalyst Dan Orenstein was at athenahealth, Inc. (NASDAQ: ATHN) for 10 years, the last 7 as General Counsel and Secretary. Prior to that, Dan practiced in the areas of corporate, intellectual property, and healthcare law with law firms in Boston and Washington, D.C. He has written and presented on health care law and IT topics throughout his career. He also served as a leader of the American Health Lawyers Association’s Health IT practice group. Daniel Orenstein, JD
  33. 33. © 2018 Health Catalyst Proprietary. Feel free to share but we would appreciate a Health Catalyst citation. Other Clinical Quality Improvement Resources Click to read additional information at www.healthcatalyst.com Health Catalyst is a mission-driven data warehousing, analytics and outcomes-improvement company that helps healthcare organizations of all sizes improve clinical, financial, and operational outcomes needed to improve population health and accountable care. Our proven enterprise data warehouse (EDW) and analytics platform helps improve quality, add efficiency and lower costs in support of more than 65 million patients for organizations ranging from the largest US health system to forward-thinking physician practices. Health Catalyst was recently named as the leader in the enterprise healthcare BI market in improvement by KLAS, and has received numerous best-place-to work awards including Modern Healthcare in 2013, 2014, and 2015, as well as other recognitions such as “Best Place to work for Millenials, and a “Best Perks for Women.”

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