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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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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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.

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.

 

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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Good News for Patients Hidden in Health IT Policy Committee’s Meaningful Use Stage 2 Recommendations

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

Recently, the federal Health Information Technology Policy Committee sent its official recommendations on Meaningful Use Stage 2 to the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare and Medicaid Services (CMS). In a bit of good news for patients and their advocates, these recommendations significantly increase requirements on providers and hospitals for sharing data electronically with patients.

For example, in Meaningful Use Stage 1:

• Providers 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.*
• Providers must provide clinical summaries of each office visit to patients upon request, but these do not have to be in electronic format.*
• Providers have the option of providing at least 10% of their patients electronic access to their health information within four days of the information becoming available to the provider.  

For Stage 2, the Policy Committee’s recommendations place greater emphasis on providers and hospitals providing patients direct electronic access to their information. If the recommendations are accepted, patients will not have to request an electronic copy of their health information; they will instead have the capability to electronically view — and securely download on demand — relevant portions of their health information. This could significantly increase the demand for personal health records (PHRs) and applications that help individuals securely store, share and make use of their personal health information.

Specifically, in Meaningful Use Stage 2:

• Providers will be required to provide their patients access to view and download longitudinal health information within 24 hours of an encounter, or within four days of the provider having received the information from a lab or other external clinical site.**  
• Hospitals will be required to provide patients access to view and download information about a hospital admission within 36 hours of the encounter.**

Providers will still be required to provide patients clinical summaries of office visits, and hospitals will still be required to provide patients electronic copies of discharge instructions, but both will be able to use the view and download functionality described above to meet those objectives in Stage 2.

The Policy Committee also recommended that providers offer secure messaging to patients in Stage 2; at least 25 patients must be using this service in order for the provider to qualify for the Stage 2 payment. This is one of several instances in which the threshold is deliberately low in order to give providers time for implementation and to get patients accustomed to using the service.

The Policy Committee also adopted recommendations to deal with the privacy and security issues raised by the view and download functionality in Stage 2. For example, patients must be able to download information securely, and the information must include information on data provenance so that any subsequent users, including other providers, can know the data’s origin and the date it was created. Providers and hospitals also must establish processes to properly identify and authenticate patients who use view and download functionalities.

Additionally, in a move that’s sure to interest patients, the Policy Committee once again signaled its intent to include in Stage 3, which is scheduled to begin in 2015, requirements that deal with accepting electronic data from patients.

The Policy Committee’s Meaningful Use Stage 2 recommendations are not the final word on Stage 2. The final Meaningful Use criteria are set by CMS, and CMS’ proposed rule for Stage 2 likely will not be released until the end of the year. However, CMS relied significantly on the Policy Committee’s recommendations for Stage 1, so these recommendations are a strong signal of what’s to come in the very near future.

Do you see these recommendations as good news for patients and patient advocates? Tell us what you think by leaving a comment.

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* Providers and/or hospitals must successfully execute these processes in response to at least 50% of patient requests in order to qualify for the Meaningful Use Stage 1 payment.

** Providers must provide this functionality to at least 10% of their patients in order to qualify for Meaningful Use Stage 2 payment.

More Patient Engagement in Meaningful Use

Bob Belfort, Manatt, Phelps & Phillips, LLP

As National Program Director Patricia Flatley Brennan and Deven McGraw of the Center for Democracy & Technology have discussed in recent blog posts, Stage 2 of Meaningful Use may set higher standards for health care providers’ engagement with patients. For example, in Stage 1, providers need only provide patients with an electronic copy of their health information upon request 50 percent of the time. But under Stage 2, providers may be required to use online secure patient messaging to communicate with patients via e-mail.

This move toward more patient engagement in Meaningful Use leads to an important question, which PricewaterhouseCoopers (PWC) explored in a recent research paper titled “Putting Patients into Meaningful Use”: How can health care providers use health IT tools, such as personal health records (PHRs), to effectively expand the care team to include patients?

A recent study suggests that less than half of all physicians are willing to use patients’ PHRs as part of their clinical work. Mistrust of patient-generated data, time constraints, lack of financial incentives and liability concerns are several issues that could contribute to this sentiment. To truly exploit the transformative potential of health IT tools, health care providers will have to become comfortable with engaging patients as more active partners in managing their own care. This is why Project HealthDesign is so important to ensuring that the government’s larger health IT adoption efforts succeed.

We are looking forward to talking about the issue of provider liability for reliance on patient-generated data and other related issues at an upcoming meeting with our five current project teams. In the meantime, we encourage you to let us know what you think about the steps PWC outlined for using PHRs to effectively expand the care team to include patients and consumers:

• Make providers (doctors, nurse practitioners) the face of the PHR.
• Define expectations for active participation by patients.
• Keep family members in the loop.
• Work side-by-side with patients as they use their PHRs.

They seem like good baseline recommendations to us. How would you build on them to be more specific?

Related resource:

• Read the full PWC report.