Now is your Chance to Weigh In Early on Meaningful Use Stage 3

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

Just before Thanksgiving, the Office of the National Coordinator for Health IT (ONC) released a formal Request for Comment (RFC) on potential objectives for Stage 3 of the meaningful use program. Although Stage 2 of the program has not yet begun, the RFC provides a very early opportunity for members of the public to weigh in on the next set of objectives and measures providers and hospitals will need to meet in order to qualify for the final phase of HITECH EHR incentive payments. 

The RFC proposes potential Stage 3 objectives and asks more open-ended questions in the following areas:

• Improving Quality, Safety, and Reducing Health Disparities;
• Engaging Patients and Families;
• Improving Care Coordination;
• Improving Population and Public Health;
• Information Exchange; and
• Assuring Privacy and Security of Health Information.

The potential objectives and questions in the RFC were developed by the Health IT Policy Committee, and the response from the public will be used by the Committee to inform its final recommendations with respect to Stage 3. To date, CMS and ONC have relied significantly on the Policy Committee’s recommendations in developing the meaningful use objectives and certification criteria.  Consequently, this is an important opportunity for interested stakeholders to help shape the future of meaningful use.

The final rules for Stage 2 make significant strides in assuring that patients have prompt electronic access to health data generated in the course of an office visit or as part of a hospitalization, and that patients can securely e-mail their health care providers. Increasing the flow of health information to patients is critical to achieving better individual and population health and a more patient-centered health care system. 

But improving the flow of information from clinical care teams to patients will not by itself facilitate a more collaborative, patient-focused health care system. Electronic health records also should enable clinical care teams to receive relevant information from patients, and providers unaccustomed to receiving electronic data from patients may need incentives to adopt more three-dimensional models of patient engagement.  The RFC asks for public input on how the meaningful use and EHR certification programs can enable, or even provide incentives for, the collection and use by clinical care teams of “patient-generated data.” 

Specifically, the RFC proposes the following Stage 3 meaningful use menu item for providers and hospitals: 

Item SGRP 204B:  “Provide 10% of patients with the ability to submit patient-generated health information to improve performance on high priority health conditions, and/or to improve patient engagement in care (e.g., patient experience, pre-visit information, patient created health goals, shared decision making, advance directives, etc.).  This could be accomplished through semi-structured questionnaires, and EPs and EHs would choose information that is most relevant for their patients and/or related to high priority health conditions they elect to focus on.”

The RFC further asks for public input on the “readiness of standards to include medical device data from the home,” and on the following more open-ended questions:

• What information would providers consider most valuable to receive electronically from patients?
• What information do patients think is most important to share electronically with providers?
• How can the HITECH incentive program support allowing doctors ad patients to mutually agree on patient-generated data flows that meet their needs, and should the functionality to collect those data be part of EHR certification? 

The RFC further asks for “published evidence or organizational experience” to support responses to the above questions.

In addition to responding to the Stage 3 proposal and the corresponding questions, stakeholders should provide feedback on the Policy Committee’s decision to propose this objective as a “menu” item, which will make it only optional for providers and hospitals participating in the meaningful use program. The RFC notes that the Committee decided to propose this objective as a menu item based on concerns raised by the Health IT Standards Committee that most EHRs do not have the “essential functionality” to accept patient-generated data. 

The Policy Committee’s Meaningful Use Workgroup hosted a hearing on patient-generated data several months ago.  Patricia Flatley Brennan, Project HealthDesign National Program Director; Nikolai Kirienko, Chronology.MD co-project director; and I all presented testimony on the Project HealthDesign grantees’ experience with incorporating patient-generated data – specifically, observations of daily living - into clinical workflows. This testimony will help inform the Committee’s deliberations on Stage 3 criteria, but more input from the public is needed on the above questions as well as others that are focused on improving health and health care for patients.  Now is the time to weigh in; comments can be submitted electronically at http://www.regulations.gov/#!docketDetail;D=HHS-OS-2012-0007 and are due by 11:59 pm ET on Monday, January 14, 2013.  

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Hurricanes and Health IT

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

As you are probably aware, we’ve been having some severe weather events back here on the East Coast.  First Hurricane Sandy, then a Nor’easter (named Athena), which dumped snow on top of an already soggy eastern seaboard.  While the 24-hour news was replete with stories about Hurricane Sandy’s devastation, including downed subway lines, flooding and widespread power outages, some of the most disturbing stories were of New York City hospitals forced to evacuate patients in the middle of the storm.

Storied Bellevue Hospital, probably the most widely known hospital in New York City’s public hospital system, had to evacuate hundreds of patients to other hospitals after sustaining damage to its backup generators.  Bellevue is located at 1st Avenue and 27th Street in what was, at the time, flood-stricken lower Manhattan.  News reports showed hospital staff taking patients down scores of flights in dark stairwells in a perilous effort to move the patients to safety.  New York University Langone Medical Center undertook  a similar, dangerous exercise when a transformer cut power to the facility and its backup generators failed due to flooding. 

A key point that commentators have been making with regard to the value of health IT is that a natural disaster or other crisis in one part of the country does not have to place a healthcare facility’s data in jeopardy.  NYC’s Health and Hospital Corporation (“HHC”), operator of Bellevue Hospital, among others, proved the point during the storm.  HHC’s hospitals use electronic health records (“EHRs”) and HHC runs two redundant data centers, at Jacobi Medical Center in the north Bronx and in Carlstadt, NJ.  At one point, the Carlstadt site had four feet of water in the parking lot, so HHC relied completely (and successfully) on the Jacobi data center.   NYU Langone Medical Center’s EHRs were also backed up at a remote location and were not lost in the storm.  This is a contrast to Hurricane Katrina, in which so many patients’ medical records were still on paper and were lost during the storm.  These contrasting experiences suggest that fully redundant data centers should be established in geographically dispersed locations so that if one data center is affected by a storm or crisis, operations can be immediately transferred to the other data center with little to no interruption or loss of data access.

Another key lesson learned from Sandy is that emergency patient transfer problems can be minimized if hospitals participate in electronic health information exchange (“HIE”).  Many of the patients that had to be evacuated to other institutions in NYC were critical care patients for whom the evacuating hospitals likely had detailed EHRs chronicling their ailments and treatment regimens.  In the harried evacuation process, it is unlikely these records traveled with the patients.  Had all of the hospitals been participants in an active HIE network or otherwise been linked up to exchange information electronically with one another, clinicians in the receiving hospitals could have easily accessed the health records for the displaced patients. Furthermore, facilities that still had power but lost access to EHR data for one reason or another could potentially have retrieved electronic records on their own patients via an HIE during the storm.

The Executive Director of the New York eHealth Collaborative, the non-profit organization charged with building New York’s statewide health information network, summed up the situation well. He said that, looking back seven years, Hurricane Katrina became the storm that demonstrated the need for digital health records because so many paper-based medical records were lost. When the flood waters inundated hospitals, their patients’ medical histories pretty much vanished. Now, Hurricane Sandy could be the storm that underscores the importance of having a health information exchange and a tested emergency plan.

What were your thoughts watching the news reports during Hurricane Sandy? How could health IT and HIE have helped ease or prevent some of the health care-related hardship caused by the storm?

Suspension of EHR Incentives – Election Year Politics or Potential Reality?

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

Usually in the weeks before a presidential election, Congress is officially in recess; many elected officials are in their home districts or states campaigning for re-election (and also weighing in on the presidential race); and typically there are few congressional developments worth noting.

But this year has been a bit of an exception – at least for those of us who follow health reform and health information technology issues.  This week, a group of Republican members of Congress and Republican senators sent letters to HHS Secretary Kathleen Sebelius raising serious concerns about the Meaningful Use electronic medical record incentive program.

The letter from key House Republicans – Rep. Dave Camp (R-MI), Chairman of the House Ways & Means Committee, and Rep. Wally Herger (R-CA), Chairman of that Committee’s Subcommittee on Health; and Rep. Fred Upton (R-MI), Chairman of the House Energy & Commerce Committee, and Rep. Joe Pitts, Chairman of that Committee’s Subcommittee on Health (R-PA) – raises “serious concerns” that the Stage 2 final rules for Meaningful Use are too weak. Specifically, the letter points out that the requirements for exchange of clinical health information among health care professionals, such as to support transitions in care, are very low. 

The letter from key Senate Republicans – Sens. John Thune (R-SD) and Tom Coburn (R-OK) of the Senate Finance Committee, and Sens. Richard Burr (R-NC) and Pat Roberts (R-KS) of the Senate Health, Education, Labor and Pensions Committee – stresses concerns about EHR use causing increased utilization of, and billing for, health care services. The letter from House Republicans also notes this concern.  Both letters also raise concerns about the lack of interoperability among EHRs. 

The letter from Senate Republicans requests an extended briefing with administration officials to hear their responses to the concerns in the letter.  In contrast, the letter from House Republicans urges Secretary Sebelius to “immediately suspend the distribution of [EMR] incentive payments until your agency promulgates universal interoperable standards;” to “significantly increase” the Stage 2 Meaningful Use objectives; and to “take steps to eliminate the subsidization of business practices that block the exchange of information between providers.”

Are these letters just typical election year politics?  The issues raised in both letters echo concerns raised by other stakeholders.  The signatories to the House Republican letter are the Chairmen of the most important health committees and subcommittees in the House; signatories to the Senate Republican letter are members of the two relevant health committees in that chamber.  All who have an interest in the successful implementation of the HITECH EHR incentive program would be well served to monitor these developments closely.

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Federal Government Finalizes Stage 2 Meaningful Use Requirements

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) recently released a final regulation setting forth the requirements for Stage 2 of Meaningful Use under the Medicare and Medicaid Electronic Health Record Incentive Program (the “Final Rule”).  In the Final Rule, CMS adopted a number of provisions that require eligible professionals and hospitals to increase their efforts to share data electronically with patients.  As a result, the Final Rule is likely to encourage greater patient engagement in health care, something the Robert Wood Johnson Foundation advocated in comments it submitted on the proposed rule.  Here is a relevant excerpt from RWJF’s comments::

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.

RWJF’s full comments are available here.

The chart below lists the “patient engagement” requirements in the Final Rule:

Stage 2 Objectives		Stage 2 Measures
Eligible Professionals (EPs)	Eligible Hospitals (EHs) and Critical Access Hospitals (CAHs)
Provide patients the ability to view online, download and transmit their health information within 4 business days of the information being available to the EP.		1.  More than 50% of all unique patients seen by the EP during the EHR reporting period are provided timely (within 4 business days after the information is available to the EP) online access to their health information, subject to the EP’s discretion to withhold certain information.   2. More than 5% of all unique patients seen by the EP during the EHR reporting period (or their authorized representatives) view, download, or transmit to a third party their health information
	Provide patients the ability to view online, download and transmit information about a hospital admission.	1. More than 50% of all patients who are discharged from the inpatient or emergency department (POS 21 or 23) of an EH or CAH have their information available online within 36 hours of discharge   2.  More than 5% of all patients (or their authorized representatives) who are discharged from the inpatient or emergency department (POS 21 or 23) of an EH or CAH view, download or transmit to a third party their information during the reporting period.
Provide clinical summaries for patients for each office visit		Clinical summaries provided to patients or patient-authorized representatives within 1 business day for more than 50% of office visits
Use certified EHR technology to identify patient-specific education resources and provide those resources to the patient	Use certified EHR technology to identify patient-specific education resources and provide those resources to the patient	Patient-specific education resources identified by the certified EHR technology are provided to patients for more than 10% of all unique patients with office visits seen by the EP during the EHR reporting period.   More than 10% of all unique patients admitted to the EH’s or CAH’s inpatient or emergency department (POS 21 or 23) are provided patient-specific education resources identified by the certified EHR technology.
Use secure electronic messaging to communicate with patients on relevant health information		A secure message was sent using the electronic messaging function of certified EHR technology by more than 5% of unique patients (or their authorized representatives) seen by the EP during the EHR reporting period.

Also of note to Project HealthDesign:  the Final Rule includes a new “menu set” requirement that eligible professionals and hospitals record a patient’s family history.

Stage 2 begins in 2014.  In the Stage 1 meaningful use regulations, CMS established an original timeline that would have required Medicare providers who first demonstrated meaningful use in 2011 to meet the Stage 2 criteria in 2013. The Stage 2 Final Rule gives providers more time to meet the Stage 2 requirements. A provider that attested to Stage 1 of meaningful use in 2011 would attest to Stage 2 in 2014, instead of in 2013.  Therefore, providers are not required to meet Stage 2 meaningful use before 2014.

Since the Medicare and Medicaid EHR Incentive Programs began in January 2011, more than 120,000 eligible healthcare professionals and more than 3,300 hospitals have qualified to participate –23,000 more than the federal government had hoped to enroll by now, according to the U.S. Department of Health and Human Services, which oversees the programs.

The Final Rule – along with a fact sheet describing it -  are available at  http://www.hhs.gov/news/press/2012pres/08/20120823b.html

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No Sleepy Summer for Project HealthDesign’s Policy Efforts

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

Ordinarily August is a slow month for federal policy, particularly in an election year. Congress goes on recess, and it is a popular month for family vacations. But August has been a month of milestones for Project HealthDesign:

ODLs Being Considered for Inclusion in Stage 3 of Meaningful Use

On August 1, the federal Health IT Policy Committee met to begin deliberations on potential meaningful use and EHR certification criteria for Stage 3 of the EHR incentive program. The Policy Committee’s meaningful use workgroup presented preliminary recommendations for Stage 3 criteria; under consideration is a requirement that patients be provided with the ability to report patient-generated data to providers and hospitals. Observations of daily living (ODLs) are specifically mentioned on the list of acceptable types of patient-generated data.

Although the Policy Committee is just beginning to deliberate the proposed Stage 3 criteria, the presence of ODLs on the initial list of options for provider incorporation of patient-generated data into the EHR is a significant development. The testimony of Nikolai Kirienko, co-director of Project HealthDesign’s Chronology.MD team, and Patti Brennan, Project HealthDesign national program director, at the Policy Committee’s recent hearing on patient-generated data helped make the case for having ODLs as an option for incorporating patient-generated data to meet Stage 3 meaningful use.

Policy Committee deliberations about Stage 3 criteria will continue into the fall, and a formal Request for Public Comment on proposed criteria is planned for release in November 2012. It will be critical for proponents of including patient-generated data such as ODLs into clinical workflows to continue to weigh in on Stage 3 discussions.

Project HealthDesign Spotlighted at Briefing on Capitol Hill

On August 13, Project HealthDesign was the topic of a briefing sponsored by the Alliance for Health Reform, the Bipartisan Policy Center, and the Robert Wood Johnson Foundation. The briefing was carried live by C-SPAN 2 and featured Stephen Downs (Robert Wood Johnson Foundation), Stephen Rothemich (Project HealthDesign’s BreathEasy team; Virginia Commonwealth University), and Deven McGraw (Project HealthDesign’s Regulatory and Assurance Advisory Group; Center for Democracy & Technology) — as well as Joy Pritts (Chief Privacy Officer, Office of the National Coordinator for Health IT).

The briefing, which took place in the Dirksen Senate Office Building, was well attended. Those present were particularly interested in hearing more about how clinicians in the BreathEasy project incorporated ODLs into clinical workflows, and how the health care system can financially support innovative models of care like those in Project HealthDesign.

The briefing also provided an opportunity to draw attention to “Lessons from Project HealthDesign: Strategies for Safeguarding Patient-Generated Health Information Created or Shared through Mobile Devices” (pdf), a new paper from Project HealthDesign’s Regulatory and Assurance Advisory Group (Manatt, Phelps & Phillips, LLP, and the Center for Democracy & Technology), which was published in late July by the Journal of Healthcare Information Management (JHIM). The paper draws on the experiences of the five current Project HealthDesign grantee teams and the approaches they used to implement device and security precautions.

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Alliance for Health Reform Briefing Featuring Project HealthDesign Today

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

Tune in to C-SPAN 2 today at 12:15 p.m. EST (11:15 a.m. CST) for “A Different Way of Thinking About Health Information,” an Alliance for Health Reform briefing. The briefing will feature three Project HealthDesign panelists — Stephen Downs (Robert Wood Johnson Foundation), Stephen Rothemich (Project HealthDesign’s BreathEasy team; Virginia Commonwealth University), and Deven McGraw (Project HealthDesign’s Regulatory and Assurance Advisory Group; Center for Democracy & Technology) — as well as Joy Pritts (Office of the National Coordinator for Health IT).

The briefing will focus on Project HealthDesign's approach to health information and data and will also include challenges and promising practices from Project HealthDesign's BreathEasy team. Additional topics will include mobile health, safe transmission of patient-generated health data, and meaningful use. Learn more.

Update: Watch a recording of the briefing online at C-SPAN 2

Paper Looks at Strategies for Protecting Patient-Generated Data on Mobile Devices

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

The Journal of Healthcare Information Management (JHIM) recently published “Lessons from Project HealthDesign: Strategies for Safeguarding Patient-Generated Health Information Created or Shared through Mobile Devices” (pdf), a new paper from Project HealthDesign’s Regulatory and Assurance Advisory Group. Experts from Manatt, Phelps & Phillips, LLP, and the Center for Democracy & Technology co-authored the paper, which appears in the summer issue of JHIM.

The paper draws insights from Project HealthDesign’s five Round 2 grantee teams (2010-12). In the absence of established best practices for safeguarding patient-generated data created and/or shared through mobile devices, each team implemented a unique approach to device and data security. Whereas clinical data is subject to the HIPAA Security Rule, patient-generated data is not. Even so, during their studies, several Project HealthDesign Round 2 grantee teams implemented systems or approaches in which patients shared data about their observations of daily living (ODLs) — one form of patient-generated data — with their health care providers. The resulting strategies for protecting patient-generated data should prove valuable if and when it becomes more common for patients to share with clinicians select data (or summaries of the data) they’ve generated outside of the clinical setting.

The grantee teams’ approaches inform the strategies shared in this paper. Topics include data encryption; limiting the nature and extent of the data that’s transmitted; equipping patients to assess the risks of storing and transmitting the health data they generate; and educating patients about options for protecting the data. Finally, the paper encourages health care providers to thoughtfully weight the risks of storing and transmitting patient-generated data on mobile devices with patient-generated data’s benefits for clinical care and individuals’ self-management.

Read the paper (pdf).
Learn more about our Regulatory and Assurance Advisory Group.

Update on the Status of the FDA’s Regulation of Mobile Apps

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

Last July, the U.S. Food and Drug Administration (FDA) issued draft guidance on how the agency intended to regulate certain mobile medical applications (apps). My colleague, Deven McGraw, described the guidance in a post last year. The draft guidance sparked heated debate. And some in Congress recently pushed to delay the FDA’s final adoption of the guidance for fear that it might stifle innovation.

The story of Congress’s brush with the proposed guidance is brief but noteworthy. During a Senate Health, Education, Labor and Pensions Committee hearing in April 2012 on the Food and Drug Administration Safety and Innovation Act, the legislation that authorizes the FDA to collect user fees from the companies it regulates, Senator Michael Bennet (D-CO) proposed an amendment that would have placed a moratorium on the FDA’s publication of the final guidance.  “I appreciate very much the work the FDA has done to receive stakeholder input, but this interaction between health information and medical devices must be handled delicately. Technology is evolving and being adopted rapidly. I think Congress must provide the proper due diligence on this issue for our constituents, including a number of startups, small businesses, and patients in my home state,” said Bennet as he described his rationale for the moratorium.

Ultimately, Congress passed the Food and Drug Administration Safety and Innovation Act without the moratorium. As enacted, the Act allows the FDA to move ahead with its plans to regulate mobile medical apps while the U.S. Department of Health and Human Services develops a report on an “appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety and avoids regular duplication.”

Now that the specter of a moratorium is no longer, the FDA is expected to release its final guidance as soon as the end of the year. A brief refresher on the FDA’s regulation of medical devices and on the guidance, as the FDA proposed it in July 2011, is below.

1. Background on the FDA’s Regulation of Medical Devices

A product is a medical device under the federal Food, Drug and Cosmetic Act (the FDCA) if it is “an instrument, apparatus, implement, . . . including any component, part, or accessory, which is . . . [either] intended for use in the diagnosis . . . or . . . cure, mitigation, treatment, or prevention of disease, . . . [or] intended to affect the structure or any function of the body of man . . .”  The FDA has stated that for software to fall under this definition, “it is sufficient that it is intended to be used in the process of diagnosis, preventing, or treatment of medical conditions, and it is not necessary that the software actually make or recommend a final diagnosis.” The FDA evaluates intended use by looking at factors surrounding the product’s promotion and distribution.

Vendors of software that qualifies as a medical device must register as manufacturers and list their products with the FDA. The FDA classifies and regulates devices under three categories, according to the amount of potential risk associated with the device’s intended use and indications for use. Class I devices present the lowest risk and are typically exempt from the pre-market submission process, but are subject to general controls required for all devices, including registration, labeling, adverse event reporting, and good manufacturing practices. Class II devices must generally undergo the pre-market notification process. Class III devices are most stringently regulated and require pre-market approval.

2. The FDA’s Draft Guidance on Regulation of Mobile Medical Apps

The FDA’s July 2011 draft guidance document indicated that the Agency intended to apply its regulatory oversight to a subset of mobile apps called “mobile medical apps,” defined as a mobile app that meets the definition of a “device” that either is used as an accessory to a regulated medical device, or transforms a mobile platform into a regulated medical device. The FDA proposed to monitor and apply enforcement discretion to other apps that qualify as devices but do not meet the mobile medical app definition; a manufacturer may choose to register and list, and to seek the FDA approval or clearance for such apps.

The guidance also listed certain apps that the FDA does not consider to be “mobile medical apps,” including “mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.”  Examples of health and wellness apps are provided in the guidance, and include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, etc. In contrast, a mobile medical app is one that is intended for “curing, treating, seeking treatment for, mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition.”

As Deven pointed out in her post last summer, the FDA tried to draw clear lines and offered more examples of mobile medical apps in the guidance (see appendix A). However, the distinction between mobile medical apps and health/wellness apps is not always clear. Today, medical conditions are significantly improved — and even prevented — by healthy behaviors, and providers might prescribe or at least recommend particular diet or exercise protocols as part of medical treatment. Many mobile health applications in development and in active use today fall in a gray area between medical and health/wellness. Where do you think the consumer-facing health applications that the Project HealthDesign teams are testing fall?

Comments on the FDA’s draft guidance were due by October 19, 2011 and reports indicate that the FDA received no small amount of feedback. We anxiously await the final guidance and will keep everyone posted.

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Project HealthDesign Comments on Nationwide Health Information Network Request for Information

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

This comment was submitted to ONC in response to a request for information on the Nationwide Health Information Network: Conditions for Trusted Exchange (pdf). The comment period for this RFI is now closed.

As director of Project HealthDesign, a national program of Robert Wood Johnson Foundation’s Pioneer Portfolio, I respectfully submit these comments on the Nationwide Health Information Network: Conditions for Trusted Exchange Request for Information, issued May 15, 2012. Project HealthDesign is a national program of Robert Wood Johnson Foundation’s Pioneer Portfolio, and was established in 2006 to foster innovation in personal health technology. Since 2006, the program has involved 14 interdisciplinary teams that have worked with hundreds of patients and clinicians to develop and implement systems that allow patients to self-track information about their daily lives and health. We call this information, which ranges from data about an individual’s mood to insights about his or her energy or pain levels, observations of daily living (ODLs).

We applaud ONC’s efforts towards the governance of the Nationwide Health Information Network (NwHIN), and support the end goal of robust data exchange that is both safe and secure. Additionally, we are encouraged to see several conditions for trusted exchange (CTEs) that acknowledge the importance of patients’ roles as direct participants in health information exchange (e.g., S-3: allowing individuals a meaningful choice regarding whether their IIHI may be exchanged, S-8: allowing individuals to request a correction or annotation to individually identifiable health information (IIHI)).

Please consider the following comments on specific CTEs:

Condition S-3: An NVE must ensure that individuals are provided with a meaningful choice regarding whether their data may be exchanged by the NVE

We support this effort to engage individuals by allowing them to opt in or out of data exchange. This condition will also allow individual patients to see themselves as direct participants in the exchange process. However, caution should be taken to understand the individual health and public health consequences for opting in or out of data exchange. Trade-offs will need to be made in prudent ways.

            Question 28: Under what circumstances and in what manner should individual choice be             required for other electronic exchange purposes?

            We encourage you to consider whether it might be appropriate for individuals to opt in or out of             data exchange at a more granular level (e.g., opt in to all data exchange except the exchange             of data related to behavioral health). However, this approach would require a reliable system for             keeping track of individual’s granular preferences, as well as good privacy management             strategies that lay people are able to understand.

Condition S-6: An NVE must not use or disclose de-identified health information to which it has access for any commercial purpose.

We agree with this condition. We also recognize the importance of establishing a clear definition of what qualifies as a “commercial” purpose in order to avoid creating obstacles to the use of de-identified data for research and public health purposes.      

            Question 38: On what other entities would this have an effect?

            This provision would serve to increase not only providers’ trust in exchanging their data through             an NVE, but also patients’ trust in the exchange.

Condition S-8: If an NVE assembles or aggregates health information that results in a unique set of IIHI, then it must provide individuals with electronic access to their unique set of IIHI.

            Question 40: What further parameters, if any, should be placed on what constitutes a             “unique set of IIHI”?

            No additional parameters should be placed to qualify what constitutes a unique set of IIHI. Any             IIHI not accessible to individuals through a singular channel should be made available as             described.

Condition S-9: If an NVE assembles or aggregates health information which results in a unique set of IIHI, then it must provide individuals with the right to request a correction and/or annotation to this unique set of IIHI.

            Question 42: Are there any circumstances where an NVE should not be required to provide             individuals with the ability to correct their IIHI?

            No. Allowing individuals the ability to correct their IIHI when incorrect or incomplete (as             described in the HIPAA Privacy Rule) will help build patient trust in the data exchange process.             We also recommend using an audit trail to document when original data sources have been             modified.

Thank you for providing this opportunity to comment on the Request for Information. We appreciate ONC’s leadership in this area and look forward to a set of evolving CTEs that foster safety, security, and meaningful exchanges of data. For more information about our work, please contact me directly or visit projecthealthdesign.org.

Read more health policy comments from Project HealthDesign.

Patient-Generated Data Governance: Fitting into the Clinical Setting

Dorothy Miller, J.D., M.P.H., Health Policy Project Assistant, Project HealthDesign National Program Office

This post is second in a series contemplating governance of patient-generated data in a clinical setting.

How can we encourage providers to integrate patient-generated data into their clinical decision-making? Providers need to feel confident that the patient-generated data they are accessing is trustable and authentic. Providers often have limited time to meet with patients and could see patient-generated data as an additional task to be completed, instead of a way in which patients can effectively communicate a richer picture of their day-to-day health.

Providers can think about patient-generated data fitting in with a traditional model of clinical decision-making in two ways. First, the data can be considered another means of understanding a patient’s description of their health. The model below (see Figure 1) shows the patient-generated data entering the clinical workflow as a type of information presented to the provider by the patient as they describe their condition.

Figure 1

A provider might traditionally ask a patient to describe their health status and expect an answer that describes the patient’s experience. With patient-generated data, the patient uses an alternate method to explain her health status and related experiences. A second way that patient-generated data can be integrated into clinical decision-making is for the provider to access patient-generated data as an external source of knowledge. The model (Figure 1) also shows the patient-generated data in that capacity, informing the provider as an external resource. Along with test results, medical history, and other types of information a provider consults, the provider may also access patient-generated data to provide additional information. 

Figure 1 demonstrates how patient-generated data can be integrated into the clinical setting. By understanding patient-generated data’s integration into clinical decision-making, we can create governance tools that integrate the principles emphasized in the previous blog post: data accuracy, integrity, and appropriate use. So what types of governance tools would encourage providers to take these steps in integrating patient-generated data at both levels? Providers should be encouraged to integrate patient-generated data into clinical workflows. Today, many patients interact with providers without the opportunity to discuss their patient-generated data. One solution to this challenge is clinical workflows that give patients opportunities to share their data. If the provider is worried about being overwhelmed with data that is voluminous or difficult to interpret, a clinic could provide standardized summaries accessible to providers, without compromising patients’ abilities to collect and generate data as they desire. 

Regarding laws and policies that govern patient-generated data, we need to thoughtfully and carefully balance provider concerns with the advantages patient-generated data can give patients and providers. Laws and regulations should be designed that give providers confidence in patient-generated data, both in terms of data accuracy and data integrity. When providers feel confident that the patient-generated data they receive is trustable, accurate, and reflects the patient’s day-to-day experiences, they may feel more confident in acting on that data. Clear guidelines allow patients to be comfortable with sharing their own data and may decrease providers’ concerns about liability stemming from using patient-generated data. 

If you’re wondering how provider liability fits into this picture, stay tuned. Our legal and policy advisory group at Manatt, Phelps & Phillips, LLC, and the Center for Democracy & Technology is working on a paper on this exact topic, and we will share more information about it soon.

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Citation for Figure 1: Robert B. Elson et. al. The Practice of Informatics: Viewpoint: An Industrial Process View of Information Delivery to Support Clinical Decision Making: Implications for Systems Design and Process Measures J Am Med Inform Assoc 1997; 4:4 266-278 doi:10.1136/ jamia.1997.0040266.