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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Onward, HealthVault (and Others!)

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

In June, as soon as Google mentioned its plan to discontinue the Google Health personal health record (PHR) platform, speculators began wondering whether Microsoft HealthVault would eventually follow suit. And once Microsoft and GE announced plans to spin their health groups into a new joint venture, the questions began to flow even more freely:

“It remains to be seen whether HealthVault will follow the Google Health PHR into oblivion.”
- “Microsoft GE Healthcare Joint Venture – A Sign of Weakness or Strength?,” The Health Care Blog

“… Microsoft did state that they’ll hang onto HealthVault, but even here, that is more likely a by-product of no one wanting to take on HealthVault rather than Microsoft’s strong desire to continue to try and build a viable, revenue-generating entity out of it. Do not be too surprised if, in a year’s time, HealthVault falls to the wayside much like Google Health did this year.”
- “Microsoft Bows Out of the Clinical Market,” Chilmark Research

In response, the HealthVault team met the questions head-on by holding their first “State of the Union” webinar on Jan. 13. The webinar, which was open to the public, focused on the HealthVault team’s vision for 2012, including plans for establishing a critical mass of users. Sean Nolan, chief architect of Microsoft’s Health Solutions Group, emphasized the team’s desire to see “people worldwide using online health tools to change health care.”

Several of our current Project HealthDesign teams are using HealthVault as a data repository and platform for participants to access their observations of daily living (ODLs) and other patient-generated data. That’s why we were interested to see where the HealthVault team would be focusing in the immediate future. Our teams have benefited from building on top of existing personal health platforms like HealthVault and TheCarrot.com. And although we don’t see these platforms as ends unto themselves, but rather as important components of a health data ecosystem (one that includes sensors and apps to record patient-generated data, personal health platforms to store and manage the data, dashboards and apps to review the data, and clinical EHR systems to bring data from patients’ daily lives into the clinical environment), there remains a critical and important role for platforms that accept and expose data from many sources.

We want to encourage everyone who’s working to advance this suite of health information tools, including HealthVault and TheCarrot.com, to hang in there. We know you’re ready to see more widespread interest and higher rates of consumer adoption. Frankly, we think the time for personal health platforms and a whole range of additional personal health tools is coming. We can’t wait to see consumers take charge of their health outside of clinical visits by diving into the health data ecosystem and putting the great tools you’re developing to work. Onward!

Recruitment Issues

Anind Dey, Ph.D., dwellSense Principal Investigator, Carnegie Mellon University

Throughout our project, we have had issues with recruiting subjects for our study. Our goal was to recruit 30 elders, along with their caregivers and doctors. However, we have struggled to recruit 20 subjects. There are a number of possible reasons for this. Some are due to not being targeted enough in recruiting, and some are due to not having enough constraints. To perform our study, we require a great deal of access to subjects and their apartments in order to perform assessments, to regularly check the state of the display and sensors, and to replace batteries.

From a time and manpower perspective, we needed to recruit subjects within a small geographic area. Otherwise, the commute time to and from our participants' apartments would have been unmanageable. So, we made a choice to identify a small number of locations from which to recruit subjects. That drastically limited our subject pool, but having subjects spread around the city would have reduced the number of subjects we could have actually worked with, too. It was not easy to identify the potential locations or potential subject populations centered in an area, particularly because we weren't looking for individuals with particular disabilities or diseases. Instead, we were looking for elders who were "at risk" but not necessarily exhibiting signs of cognitive decline.

Once we found suitable locations with large potential subject pools, we faced other difficulties in recruiting. One issue was the amount of time we wanted participants to commit to being part of our study. Because we expect the personal health information we collect via sensors to provide value over time rather than immediately, and because we wanted enough time for participants to get over the novelty factor of our embedded assessment appliances and displays, we needed participants to commit for several months. Many potential subjects had a hard time making this long-term commitment.

We also wanted to maximize the number of assessments we could make for each participant. This meant we were looking for subjects who regularly perform the three activities we monitor: coffee making, making/receiving phone calls, and taking medicine. Some potential subjects didn't work out because they drank tea instead of coffee, or made instant coffee rather than using a coffee maker. These activities, though perfectly reasonable, made them inappropriate for our study. Others had digital phone lines that were not compatible with our phone sensing hardware, which works with analog phone lines. Furthermore, some took pills from the original pill bottles rather than from pill boxes. We were afraid that changing someone's habits (from using pill bottles to using pill boxes) would impact their behavior too much and introduce errors in actions, so we removed these individuals from the potential subject pool. In the end, we chose to accept subjects if they used pill boxes and satisfied the requirement for either the coffee making or the phone use.

Further complications arose from the nature of the research itself. When they heard our description of the study, some subjects declined to participate. When asked why, it was clear that participating in such a study and using such a system that tracks and represents health information served as another reminder of their declining physical and/or cognitive health. The last thing they wanted was a "constant" notification of how they were performing everyday activities.

We are continuing to recruit subjects, but this is a slower process than we had expected. We’ve definitely learned a lot about recruiting for this type of study.

Learn more about the dwellSense project.
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Creative Commons photo by jcestnik.

Project HealthDesign Director Shares Views on Patient Engagement in InformationWeek

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

Head over to InformationWeek today to read “Is 2012 the year of online patients?,” which features insights from Project HealthDesign Director Patricia Flatley Brennan, Ph.D., R.N. In the article, Marianne Kolbasuk McGee explores what 2012 might hold for patient engagement in health care. She also interviewed Missy Krasner, a former Google Health executive. Read an excerpt below, or visit InformationWeek to read more.

“… doctors will have to convince patients to get more involved in their own healthcare--including using their own data to keep better tabs on their illnesses. In fact, payments tied to better patient outcomes--helped by smarter use of patient data-- is a big driver for more healthcare providers to participate in patient engagement initiatives, Brennan said.

Yet, with so much on doctors' plates as it is—"most doctors don't want a tsunami of new data" added to EHR and other systems from their patients' home health monitoring or wellness devices, said Brennan. That's especially true since most of this data doesn't warrant emergency care.

However, when there is an issue that requires immediate attention, Project HealthDesign teams have found that patients' monitoring data can be successfully sent to or shared with other clinicians, such as triage nurses or case managers, who can often help facilitate earlier intervention, or give feedback to patients without overwhelming doctors.”

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.

KevinMD Features Op-Ed from Past Project HealthDesign PI

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

Visit KevinMD.com today to read “Using a mobile app to help chronic pain,” an op-ed by Roger Luckmann, M.D., M.P.H. Dr. Luckmann, who is a family physician, served as principal investigator of a past Project HealthDesign team from the University of Massachusetts Medical School. His team designed an electronic pain and activity diary to help patients document their daily pain experiences, medication regimens and physical activities. This system inspired Dr. Luckmann’s work on a similar mobile application that is set to launch in the Mac App Store soon. Read the article to hear Dr. Luckmann’s perspective on effectively managing pain by learning more about patients’ daily lives and activities.

Top 5 Posts from 2011

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

Join us as we look back at our most-read posts from 2011. We’re grateful for your interest and the many conversations these posts have sparked throughout the past year. We look forward to sharing more updates with you, and encourage you to tell us what you'd like to hear about in future posts.

1. BreathEasy Android Application and Web Dashboard Design
   “The BreathEasy Android application is designed to be an easy-to-use tool that allows study participants to enter observations of daily living (ODLs) such as peak flow readings, asthma triggers, stress and activity levels, sleep patterns, symptoms and medication use.”
   
   
2. PCAST Report Comment: Looking Toward Truly Patient-centered Health Data
   “Yet even as I affirm the overall spirit of the report, I find myself searching for a more explicit focus on the patient. I was hoping for a report addressing health information technology, but this report focuses more on health care information technology.”


3. When is a Mobile App a Mobile Medical App?
   “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 this gray area between medical and health/wellness.”
   
   
4. Patient Engagement: A Key Ingredient in Accountable Care Organizations
   “We think that knowing a patient’s observations of daily living (ODLs) could help ACOs meet quality improvement goals under the Medicare Shared Savings Program. We also believe that the program, with its focus on patient engagement and care coordination, could go a long way toward convincing health care providers to incorporate patient-defined, patient-generated health information into the clinical care setting.”
   
   
5. In the Wake of Google Health
   “Beyond support for clinical health information, we know people also want support for personal health information like observations of daily living. These types of personal information have little representation within current EHRs. Thus, a central challenge will be to provide systems that can integrate both clinical and personal health information in meaningful ways.”

What other posts from our blog or other sites are on your must-read list from 2011? Let us know in the comments.

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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