Seeking Public Comment on Proposed Governance of the Nationwide Health Information Network

Deven McGraw, Proje­ct HealthDesign Regulatory and Assurance Advisory Group, Center for Democracy & Technology

On May 15, the Office of the National Coordinator for Health IT (ONC) released a formal Request for Information from the public (RFI) on governance of the Nationwide Health Information Network (NwHIN). ONC defines NwHIN as a "set of standards, services, and policies that enable secure health information exchange over the Internet." In the early years of federal health IT initiatives, the NwHIN was described as a “network of networks,” reflecting a strategy of achieving nationwide health information exchange by establishing state or regional health information exchanges and linking them together. The new definition reflects the belief that exchange does not require the building of new networks but also can be achieved through the use of common, interoperable standards in an environment of trust.

In the RFI, ONC observes that electronic exchange to date “has been governed by a patchwork of contractual relationships, procurement requirements, State and Federal laws, and industry self-regulation,” and this this patchwork has led to “asymmetries in the policies and technical standards.” In developing governance conditions, ONC hopes to establish “a consistent, baseline set of ‘rules of the road’ for electronic exchange.”

The RFI proposes "conditions for trusted exchange" (CTEs) in three areas:  safeguards (which focus on the protection of individually identifiable health information), interoperability (which focus on the technical standards needed for interoperable exchange), and business practices (sound operational and financial practices). These CTEs would impose some requirements that go above and beyond what current law requires. For example, one of the safeguard CTEs would require entities to implement security safeguards like encryption that currently are not mandatory for health care providers. ONC anticipates that the CTEs will be reviewed annually and evolve over time (some will be retired, others will be added), as exchange needs become more robust and standards are improved. The 16 proposed CTEs, and the specific questions ONC has asked the public to weigh in on, can be found in the RFI.

The entities ONC intends to govern are not individual providers but instead the intermediaries that facilitate exchange among providers and patients. Examples include state or regional health information organizations (RHIOs), health information exchanges (HIEs), and private networks established by vendors. The RFI proposes that intermediary entities be validated with respect to their compliance with the governance CTEs. Those intermediary entities that are validated are then called NwHIN Validated Entities or NVEs. The RFI also proposes oversight over the validators; ONC will remain responsible for overseeing NwHIN governance but also intends to seek and select a private-sector entity to have oversight over the validators.

NwHIN governance is proposed to be voluntary, although ONC anticipates that they could become mandatory conditions for participation in certain federal programs. The idea is to create a set of conditions for trusted exchange that intermediary entities will seek to follow – and those intermediaries will agree to exchange data with other intermediaries who have committed to following the same conditions.

Comments on the RFI are due on June 14, and can be filed electronically. The Health IT Policy Committee also will be considering comments to the RFI at its June 6 meeting. ONC expects the public comments to help shape a forthcoming proposed regulation on NwHIN governance.

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RWJF Comments on Meaningful Use Stage 2 NPRM

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

Today, Robert Wood Johnson Foundation (RWJF) formally commented on the Electronic Health Record (EHR) Incentive Program’s Stage 2 proposed rule, issued by the Centers for Medicare & Medicaid Services (CMS). As a national program of RWJF’s Pioneer Portfolio, we, too, recognize health IT’s role as an important tool for improving health and health care in the U.S., and we applaud this effort toward the truly meaningful use of EHRs.

We encourage you to read a selection from RWJF’s general comments on patient engagement:

We are encouraged by efforts in the proposed rule regarding patient and consumer engagement, especially regarding secure messaging; direct, downloadable access to patient data; patient reminders; inclusion of family health history; and provision of patient education. Nevertheless, we would like to see the required percentages higher than proposed in some cases. In addition, as our Project HealthDesign makes clear, patients now expect to engage with their personal health data in apps and on mobile devices of their choosing. We expect this trend to increase significantly. Further, patients will almost certainly expect that the flow of information be in two directions. In other words, patients will reasonably expect they will have both access to personal health data but also the ability to provide personal data to their health professionals. Work by both Project HealthDesign and by RWJF’s OpenNotes project shows that health data is becoming essentially a platform for conversation between patient and health professional. Project HealthDesign uses patient-generated data to spark conversations about the course of treatment. OpenNotes enables patients to see their data and have a discussion with their health professional about that information. A recent study about OpenNotes (Ann Intern Med, 2011;155:811-819) indicates that patients feel very strongly about gaining access to actual information in their medical record. The patients in this study did not share concerns noted by physicians in the study that patients would not understand or would worry about aspects of this information.

Native apps on smartphones and tablets may currently provide the most engaging experiences with health data for the public. Unfortunately importing data about care, such as lab test results, remains a significant barrier to adoption and use for both patients and app developers alike. Ideally, efforts to liberate this data for things like these apps, other personal health information tools as well as a platform for conversations between patients and their health professionals will become a policy reality in future versions of this rule.

Read RWJF’s full comment.

The comment period for the proposed rule closes tonight at 11:59 p.m. EST. Submit a comment at regulations.gov.

Implications for Patient Engagement if the Health Reform Law Falls

Robert Belfort, Project HealthDesign Regulatory and Assurance Advisory Group, Manatt, Phelps & Phillips, LLP

It is hard to escape the news coverage about the constitutional challenge to the Affordable Care Act (ACA), and the attention being paid to the case is understandable. The ACA is arguably the most far-reaching piece of domestic legislation that Congress has passed since it enacted Medicare in the 1960s. Although the focus of the legal challenge to the ACA is on the individual mandate, which requires that almost all Americans without health insurance buy individual health insurance policies or pay fines, there could be implications for patient engagement initiatives if the Supreme Court strikes down the law.

The Supreme Court heard oral arguments relating to the constitutionality of the ACA on March 26, 27 and 28. The Court’s decision is not expected until late June. The first issue confronting the Court is whether the individual mandate should be struck down because it represents an unconstitutional exercise of Congress’ power. If the Court does decide the mandate is unconstitutional, it will then consider what should happen to the ACA’s hundreds of other provisions. The answer depends on whether some or all of these provisions are deemed “severable,” meaning that they operate independently enough of the mandate to stand on their own even if the mandate falls.

The severability issue is a critical one. A number of the ACA’s payment and delivery reform provisions encourage patient engagement and care coordination, and, at least indirectly, could go a long way toward promoting the integration of patient-generated health information into care management and other health care delivery models.  These include provisions:

• establishing a Medicare hospital value-based purchasing program that pays hospitals based on performance against quality measures;
• requiring the development of similar value-based purchasing programs for other types of providers;
• gradually reducing Medicare payments that would otherwise be made to hospitals to account for preventable hospital readmissions; and
• establishing rules governing the formation and operation of Accountable Care Organizations (ACOs).

Each of these provisions attempts to reform the current health care payment system by rewarding health care providers for coordinating care and delivering better patient health outcomes – as opposed to rewarding them for the volume of services they provide. The ACO program, for example, creates financial incentives for providers to work together to treat patients across multiple care settings, including physician offices, hospitals, and in the home. An ACO consists of a group of providers that have agreed to collaborate to coordinate care for patients enrolled in Medicare Parts A and B. ACOs are intended to be patient-centered organizations, driven by the goal of delivering integrated, efficient and cost-effective care. ACOs that achieve quality targets and succeed in providing care at a cost less than what would otherwise be expected will share in savings with the Medicare program. To succeed, ACOs will likely have to find ways to better engage patients in their own health and health care. Incorporation of patient-generated health information, like observations of daily living (ODLs), could be one way of achieving this goal.

It is currently unclear whether the ACO program and other ACA payment reforms will continue to exist if the Supreme Court strikes down the entire ACA. Some have suggested that without the ACA’s payment reform provisions, health care providers will have less incentive to engage in innovative care coordination strategies, including those involving patient-generated health information. We will continue to follow the legal challenge to the ACA with great interest, and with an eye toward how it may affect the goals that Project HealthDesign supports. Please don’t hesitate to post any questions or comments about these issues below.

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Meaningful Use on the iPad and Beyond

Nikolai Kirienko, Chronology.MD Co-Project Director, UC, Berkeley

Tablet computing at the point of care is poised to touch virtually every corner of care delivery in medicine. Yet, the currently proposed criteria for Meaningful Use Stage 2 have yet to embrace the post-PC world of medicine that’s just over the horizon. Someday sooner than we think, those large, immobile boxes chained to a desk will seem as quaint a notion as the endless stacks of paper charts they replaced.

Thankfully, Project HealthDesign offers a practical glimpse of our rapidly emerging future in action today.

By equipping patients and providers with an array of cutting-edge consumer technologies-- from iPads to WiFi biometric devices-- and putting them through their paces in clinical practice, we are able to learn a vast amount about the promise and pitfalls we're likely to encounter at scale in just a few short years.

With respect to Meaningful Use, and through Project HealthDesign, Robert Wood Johnson Foundation is characteristically ahead of the game, pioneering a scenario that, at first glance, may look ridiculous to folks steeped in the world as it is today. iPads? SMS messaging? WiFi? I can't even get my patients to show up! (Note the Estrellita team's most popular app feature: appointment tracking.)

As a member of ONC’s newly minted Consumer/Patient Engagement Power Team, it's been a privilege to work with ONC's senior adviser for Consumer E-Health, Lygeia Riccardi and MaryJo Deering, acting director of the Office of Communications, to examine the long view in the context of Meaningful Use.

They recently asked fellow patient advocates Hugo Campos, Heidi Sitcov and me to work alongside industry leaders as co-chairs of a remarkable group assembled to combine a rare blend of on-the-ground experience implementing health IT. Our task: to bring the patient voice, via direct item by item comments, before the Policy and Standards Committees overseeing the development of the Meaningful Use Stage 2 criteria.

Thanks to Project HealthDesign, I have no shortage of vivid patient experiences involving the challenges of working with electronic health data, which I hope to more explicitly detail along with our specific comments in an upcoming post.

In short, Project HealthDesign makes abundantly clear that patients today-- and in rapidly growing numbers into the future-- will expect to easily engage with their personal health data in apps and on mobile devices of their choosing. Native apps on smartphones and tablets may provide the most engaging experiences available, but importing data, such as lab test results, remains a significant barrier to adoption-- for patients and developers alike.

The SMART Platform within ONC’s Strategic Health IT Advanced Research Projects (SHARP) is working hard to reduce many of these barriers.In conjunction with existing standards, it will facilitate the role outlined early on by the Project HealthDesign Common Platform and through complementary third party services like Microsoft HealthVault.

My highest hope is that data liberation for apps, as advanced in these and similar projects, will become a policy and standards reality in Meaningful Use Stage 3 and beyond.

It will be a beautiful day when sharing components of my longitudinal health record, such as medication adherence or lab test results, with an iPad app is as simple and easy as installing an app on Facebook.

Chronology.MD, in conjunction with other interactive health history timelines such as SMART app challenge winner MyNote, or @KatieMcCurdy's inspiring medical life history will require this data for greater accuracy and to spare patients from hand transcription.

The details of my experience directing and using our app have made me a vocal advocate for the robust inclusion of patient engagement as more than just a theme in a spreadsheet. To make a transformational difference, truly liberated data will need to be hard coded into the policies and standards driving value in our rapidly evolving electronic health care economy.

Granting static electronic views of data will be a welcome improvement, as written in the current Meaningful Use criteria. But if patients can't engage with their data in order to create meaningful change in their daily lives-- via apps they might actually enjoy-- then it’s but one more health information silo that used to be on paper.  When it’s all said and done, Meaningful Use must be meaningful for patients for it to be truly meaningful at all. Thankfully, this is only the beginning.

How would you enhance Meaningful Use to aid dynamic patient engagement? Sound off in the comments so I can share your input with the Power Team.

 

White House Releases Report on Consumer Privacy, Calls for Legislation

Deven McGraw, Proje­ct HealthDesign Regulatory and Assurance Advisory Group, Center for Democracy & Technology

Project HealthDesign grantee teams have long recognized that the robust use by patients of technologies such as personal health records (PHRs) and mobile health applications to improve health and well-being depends on trust. Individuals need assurance that the personal data they collect and share using these technologies will be handled responsibly and with respect for its sensitivity. But health data collected by and shared through consumer-facing technologies is typically not covered by HIPAA or state health privacy laws.

At a roundtable on privacy and security protections for PHRs hosted by the Department of Health and Human Services (HHS) in 2010, Project HealthDesign grantees submitted testimony noting some of the privacy and security issues raised by their projects and the challenge of addressing these issues in an uncertain legal environment.  Failure by policy-makers to address this uncertainty chills innovation and places obstacles to widespread consumer adoption of promising health information technologies.

Securing enactment of comprehensive privacy policy is never easy, but the future is looking a bit brighter. Just last month, the White House released a report expressly acknowledging that “[p]rivacy protections are critical to maintaining consumer trust in networked technologies” and calling for stronger privacy rules to protect personal information, including health information, shared by consumers with private sector companies.

Specifically, the White House sets forth the following “Consumer Privacy Bill of Rights”:   

• Individual Control:  Consumers have a right to exercise some control over what companies collect from them and how they use it.

• Transparency:  Consumers have a right to easily understandable and accessible information about privacy and security practices.

• Respect for Context:  Companies should limit their collection, use and disclosure of personal data to those purposes consistent with the context in which consumers provided the data.

• Security:  Companies should maintain reasonable safeguards to control risks such as loss, unauthorized access, and improper disclosure.

• Access and Accuracy:  Companies should provide consumers with reasonable access to personal data collected about them and appropriate means to correct inaccuracies.

• Focused Collection:  Companies should collect only as much personal data as they need to accomplish the purposes that are consistent with the “Respect for context” principle.

• Accountability:  Companies should be accountable to enforcement authorities and consumers for adhering to these principles.

The White House also calls on Congress to enact legislation adopting the Consumer Privacy Bill of Rights as law and providing enforcement authority to both the Federal Trade Commission (FTC) and State Attorneys General. The White House also directs the U.S. Department of Commerce to convene multi-stakeholder groups to negotiate codes of conduct that would implement the Consumer Privacy Bill of Rights in ways tailored to the privacy issues raised by specific industry sectors.

Under the legislative approach advocated by the White House, these codes of conduct – when reviewed and approved by the FTC — would become safe harbors that insulate companies that follow these codes from liability. But even if Congress does not act, these codes of conduct — when companies voluntarily follow them — can be enforced by the FTC, which already has authority to force companies to comply with privacy commitments made to consumers. The Department of Commerce is expected to soon begin convening multi-stakeholder groups to develop the codes of conduct called for in the White House report.

Entities covered by existing federal data privacy laws like HIPAA would be exempt from the new legislation. However, the White House does call for review of whether existing laws could be “simplified” to benefit both consumers and companies.

To what extent would national, consensus-based policy protecting health data collected, used and shared by commercial companies reduce barriers to more widespread adoption of consumer-facing health technologies like PHRs and mobile apps?  Share your thoughts in the comments.

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Patient Engagement is the Hallmark of Patient-Centered Care

Project HealthDesign Comments on PCORI Draft National Priorities for Research and Research Agenda

Patricia Flatley Brennan, Ph.D., R.N., Project HealthDesign National Program Director

Editor’s note: This post is third in a series on patient engagement. Many of our health policy comments, including the one below, deal with patient engagement and patient-centered approaches to health and health care.

I appreciate the opportunity to provide comments on PCORI’s “Draft National Priorities for Research and Research Agenda” (Draft National Priorities), published January 23, 2012. I serve as director of Project HealthDesign, a national program of Robert Wood Johnson Foundation’s Pioneer Portfolio. Through Project HealthDesign, I have come to realize that being “patient-centered” means engaging patients in all parts of the care process, from designing and selecting treatment approaches, to determining relevant indicators of success, to evaluation of the desirability and achievement of the outcomes obtained. Although many groups understand “patient-centered” to mean that patients are the targets or recipients of health care, Project HealthDesign promotes a vision in which “patient-centered” means that patients are involved in the design, implementation and evaluation of care.

The Draft National Priorities addresses patient needs and preferences, and also focuses on engaging patients in identifying areas for further research. However, we believe patients have a lot more to offer than simply providing input into research priorities. Early and frequent engagement of patients and their caregivers – from characterizing a problem all the way through the process of addressing and solving it – is the hallmark of patient-centered care. Patient-centered care requires more than a one-time engagement of patients; it requires systematic, deliberate and ongoing engagement of patients in dialogue about priorities, clinical investments and therapeutic strategies.

We challenge PCORI to create effective research models that engage patients, garner patient participation across the care continuum, and provide meaningful indicators of the patient-centeredness of the care provided. PCORI must take the lead in determining the extent to which patient-centered care improves the lives and well-being of individuals and/or results in a more efficient and effective health care delivery system.

Specifically in regard to priority 3, part D (page 19), I present Project HealthDesign as an effective case study for what an “innovative approach” might look like. Following a design-demonstrate-evaluate process, Project HealthDesign’s five current initiatives are working with more than 135 patients with various chronic diseases. Because we engaged teams who share a common focus on patient-centeredness but are addressing different clinical care problems, each team has been able to leverage findings from the other teams.

Through these linked grants, the teams have equipped their patient participants to track, review and share with their care providers “observations of daily living,” or ODLs. Five teams are engaged in evaluating the impact of sharing ODLs on patients’ care and care outcomes. These ODLs are patient-generated, can range from information about an individual’s pain or energy levels to truly unique observations about a patient mood state, and may serve as another class of patient-centered outcomes. Reports resulting from this data help patients and their caregivers take action to improve the patient’s day-to-day health outside of the clinical setting. These reports also help to improve the quality of clinical visits and provide clinicians a clearer view of the patient’s daily life and health. For more information about our work, please contact me directly or visit projecthealthdesign.org.

This comment was submitted to PCORI in response to its “Draft National Priorities for Research and Research Agenda.” To learn more about PCORI, please visit pcori.org.

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Proposed Stage 2 Meaningful Use Rule Strong on Patient Engagement

Robert Belfort, Project HealthDesign Regulatory and Assurance Advisory Group, Manatt, Phelps & Phillips, LLP

The Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC) released the proposed rule governing Meaningful Use Stage 2 under the Medicare and Medicaid Electronic Health Record Incentive Program last week. In a move that is likely to promote patient engagement, the agencies took the advice of the Health IT Policy Committee and beefed up the requirements on eligible professionals and hospitals for sharing data electronically with patients.

The patient engagement requirements in Meaningful Use Stage 1 are important but limited. For example, in Meaningful Use Stage 1:

• Eligible professionals and hospitals must provide patients electronic copies of their health information upon request and within three business days
• Hospitals must provide electronic copies of discharge instructions to patients upon request.
• Eligible professionals must provide clinical summaries of each office visit to patients upon request, but these do not have to be in electronic format.
• Eligible professionals have the option of providing at least 10 percent of their patients electronic access to their health information within four days of the information becoming available to the eligible professional. 

In the proposed rule for Stage 2, CMS and ONC are proposing to require eligible professionals and hospitals to provide patients with direct electronic access to their information. Patients will no longer have to request an electronic copy of their health information; instead they will have to be provided with a mechanism to electronically view — and securely download on demand — relevant portions of their health information.

Specifically, CMS and ONC are proposing the following patient-engagement-related objectives for Stage 2 of Meaningful Use:

For eligible professionals: 

• Provide patients the ability to view online, download, and transmit their health information within 4 business days of the information being available to the eligible professional.
• Provide clinical summaries for patients for each office visit.
• Use secure electronic messaging to communicate with patients on relevant health information.

For hospitals: 

• Provide patients the ability to view online, download, and transmit information about a hospital admission.

For both:

• Use certified EHR technology to identify patient-specific education resources and provide those resources to the patient.

Although these new objectives and their attendant measures do not hew exactly to those proposed by the Health IT Policy Committee, they are very close and represent CMS and ONC’s commitment to ensuring that health care providers use EHRs to improve not only their own access to health information but their patients’ access as well.

Further, beginning in 2014, CMS and ONC are proposing to replace the Stage 1 objectives requiring eligible professionals and hospitals to provide patients with an electronic copy of their health information/discharge instructions and with timely electronic access to their health information with the new view, download and transmit objectives proposed for Stage 2.

We think the patient engagement provisions in the proposed rule are good news for patients and that they could increase the demand for personal health records and applications that help individuals securely store, share and make use of their personal health information. We’d also like to give kudos to the Project HealthDesign team for providing the Health IT Policy Committee with valuable comments about extending the effect of meaningful use of EHRs beyond clinicians and to patients and their family members.

Of course, there is more work to be done. CMS and ONC will take public comments on the proposed rule before finalizing it. The comment period will last 60 days and we can expect a final rule sometime this summer. At that point, we’ll set our sights on Stage 3, which is scheduled to begin in 2015 and where we might see requirements that deal with accepting electronic data from patients.

The proposed rule will be published in the Federal Register on March 7, 2012. In the meantime, it is available for display or as a fact sheet.

Let us know your reaction to the new patient engagement requirements in Meaningful Use Stage 2 below.

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Latest Health IT Policy Developments

Deven McGraw, Proje­ct HealthDesign Regulatory and Assurance Advisory Group, Center for Democracy & Technology

A new year has started — year two of the incentive program to encourage the meaningful use of certified electronic health record technology to improve individual and population health. It’s a good time to get caught up on policy developments from the end of a very busy 2011 and provide an update on expected developments in early 2012.

On November 7, the Institute of Medicine issued a report and recommendations intended to assure the safety of EHRs. The report identifies some safety risks associated with EHRs and acknowledges the potential for safety benefits. The report also recommends the establishment of a new entity to investigate EHR safety risks and urges HHS to establish a mechanism for vendors and others to report safety-related incidents. In response to the report, ONC noted it is already in the process of developing an EHR safety and surveillance plan.

In December, the Department of Health & Human Services (HHS) announced that providers who started participating in the  meaningful use incentive program in the first year (2011) will have an additional year (until 2014) before being required to meet the more robust meaningful use Stage 2 requirements. This change, which was initially recommended by the Health IT Policy Committee, is intended to give providers a longer period of time to adjust to and implement the earliest stage of meaningful use before being required to demonstrate more robust use and exchange of health information in Stage 2.

Speaking of meaningful use, the proposed meaningful use requirements for Stage 2 are still expected to be released early in 2012. In addition, the Health IT Policy Committee has begun discussions about requirements for Stage 3, and incorporation of patient-generated data into EHRs continues to be a priority.

ONC unveiled its consumer engagement program in September, and the office is continuing to roll out initiatives to promote consumers’ use of e-health tools to improve their health:

• Earlier this month, ONC announced the Healthy New Year video challenge intended to collect short (up to two minutes) videos from consumers sharing their new year’s resolutions for the use of e-health tools to improve their health or the health of their families. The deadline to submit a video is February 16, at 5 p.m. EST. Cash prizes will be awarded to the top videos.

• On December 6, the Office of the Surgeon General and ONC launched a Healthy Apps Challenge to encourage the development and submission of technology apps that tailor health information to the needs of the consumer user and empower the public to regularly engage in and enjoy health-promoting behaviors. The deadline for entry was December 31, 2011. Winners will be announced on January 31, 2012 and finalist apps will be featured on an HHS website.

ONC also has launched efforts to gather more information about consumer concerns about e-health privacy and security. Specifically, ONC is surveying consumers (and conducting focus groups) about attitudes and preferences regarding the communication of personal health information using mobile devices. In addition, ONC will conduct annual, nationwide surveys to assess the percentage of individuals who are concerned about the privacy and security of EHRs, who report having kept any part of their medical history from their doctors due to privacy concerns, and who are concerned that an unauthorized person would see their medical information if it is sent electronically, among other key measures. ONC will assess trends in consumer privacy and security views between 2012 and 2016 and intends to compile the results into a final report.

Stay tuned for further updates.

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Project HealthDesign Health Policy Comments Featured on Pioneering Ideas

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

In 2011, Project HealthDesign provided feedback on seven proposed policies. These ranged from applauding the HHS Proposed Rule on Patient Access to Lab Reports, which would allow patients to become more engaged with their health data, to calling for better distinctions between mobile apps and mobile medical apps under the FDA Mobile Medical Application Guidance. Working together to help refine these types of policy proposals is even more critical now as we enter a new era of widespread adoption and use of health IT.

via rwjfblogs.typepad.com

Visit Pioneering Ideas today to read "Project HealthDesign Provides Input on Health IT Policies" and learn about the seven health policy comments we issued in 2011.

Institute of Medicine Weighs In On Health IT and Patient Safety

Robert Belfort, Project HealthDesign Regulatory and Assurance Advisory Group, Manatt, Phelps & Phillips, LLP

All of us working in health care are keenly aware of the importance of ensuring that health IT improves the quality of health care without creating a new set of patient safety risks. With the release of a new report titled “Health IT and Patient Safety: Building Safer Systems for Better Care” by the Institute of Medicine (IOM), the issue of health IT safety is now on the radar screen as a major policy challenge.  

IOM released the report in response to a request by the Office of the National Coordinator for Health IT (ONC) for recommendations about what a comprehensive health IT safety policy should look like. Among other recommendations, IOM suggested that the federal government create a new independent watchdog agency, along the lines of the National Transportation Safety Board, to accept reports on patient deaths, serious injuries or potentially unsafe conditions associated with health IT. IOM skirted the issue of whether the U.S. Food and Drug Administration should have immediate responsibility for overseeing health IT safety.

While the entire report is worth reviewing, I want to call special attention to the fact that the report includes a chapter devoted to the safety of health IT tools “designed to engage and support patients in health-related decision making and management of their own personal health information” (see chapter 5 “Patients and Families Use of Health IT: Concerns about Safety”). The chapter specifically references patients’ ability to use personal health records (PHRs) and other tools to record and share “activities of daily living.” It also cites “Project HealthDesign: Rethinking the Power and Potential of Personal Health Records” by Patricia Flatley Brennan, Steve Downs and Gail Casper.

The report doesn’t offer up a silver bullet for avoiding patient safety risks created by PHRs and other patient engagement tools. Rather, it highlights that health IT is one component in a larger sociotechnical system that includes technology, processes, organizational practices and the external environment, and that adding patients into the mix inserts an additional layer of complexity when it comes to patient safety.

The report’s key point about PHRs is summed up in the following quote: “Given the importance of clear patient-provider communications, special attention may have to be devoted to ensuring that computer-mediated interactions are not used inappropriately.” It goes on to note that one important way to ensure patient safety is for health care providers to manage patient expectations about how information they include in a PHR or other patient engagement tool will be used. According to IOM, health professionals, patients and their families need to develop “a shared understanding of appropriate use of patient-centered, validated data.”

Sound familiar? It should, because it’s consistent with the discussions we’ve been having with the current Project HealthDesign grantee teams about how to minimize health care providers’ medical malpractice liability when incorporating ODLs into clinical care assessments and decisions. In April 2010, the grantees raised a number of concerns, such as how to ensure the accuracy of patient-generated health data and whether health care providers are expected to review every piece of information that patients provide on a round–the-clock basis. These concerns are driving Manatt and CDT’s work on a set of recommendations to develop a shared set of expectations among patients and health care providers about the role of patient-generated data in clinical care.

Although we are formulating these recommendations with a focus on reducing health care providers’ legal liability — a cross-cutting policy issue that could stymie the incorporation of ODLs into clinical practice if not addressed — IOM reminds us that, at the end of the day, managing patients’ expectations about the incorporation of their ODLs into their care is also a patient safety issue.

The IOM report makes a total of 10 patient-safety related recommendations. I encourage everyone to review the recommendations and to read Chapter 5 of the report.

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