Drawing from within: Implantable devices yield new types of patient generated data [Video]

Project HealthDesign National Program Office

We are in the final six-month stretch of Project HealthDesign, and we’re trying to share some of our project’s most relevant and dynamic findings with respect to patient-generated data. We learned through our recent grantees’ research that familiar consumer electronic devices, like cell phones and tablets, can help patients capture observations of daily living and personal insights, and allow them to easily share these data with their clinicians. 

There’s another type of patient-generated data out there. We’ve learned from conversations with people whose health lives depend on implantable devices like cardiac defibrillators and insulin pumps, that data derived from these devices  provide important information not only about how the device is performing but also about the patient’s health state.  It is timely to figure out how to make data acquired through such implantable devices accessible and useful to patients as well as clinicians and researchers. 

In this video, Patricia Flatley Brennan offers some compelling thoughts about the need to imagine and harness this novel patient-device data to make sure it serves the ultimate health interest of patients.  Device makers and federal bodies who regulate these devices should pay particular attention. While watching this video, keep these questions in mind:  How can we ensure that patient-device data are 1) understandable to and accessible by both patients and clinicians; 2) completely secure from disruption and tampering, and 3) regulated carefully and fittingly? 

Project HealthDesign wants your input on this important matter. If you have thoughts, suggestions, ideas about all types of patient-generated data, post your comments below or send them to [email protected]

 

Terrific attendance at Project HealthDesign webinar

Wendy Swanberg, Communications Coordinator, Project HealthDesign National Program Office

More than 200 people signed up for last week’s webinar, "From the iPhone to the EMR: Can patients' personal health data help improve their clinical care?” to learn about the latest work by Project HealthDesign’s grantee teams.  Co-hosted by Stephen Downs of the Robert Wood Johnson Foundation (RWJF) and Patricia Flatley Brennan of the National Program Office, the webinar set a wider lens on the growing interest in weaving patient-generated data into the matrix of clinical health care.   

Steve Downs explained that as part of RWJF’s Pioneer Portfolio, Project HealthDesign was created to stimulate innovation in the area of personal health records.  “We laid out a vision where your medical record would serve as a platform” he explained, “and then lots of third-party apps could be tailored to your specific needs.”  The project’s five research teams took that vision and created applications tailored for patients with chronic conditions, from asthma to obesity to Alzheimer’s disease.

Project director Patti Brennan described what might be the most significant finding to arise from the project, the discovery that information from patients’ daily lives -- data about things like diet, mood and stress level – can play an important role in managing health care.  These “Observations of Daily Living,” or ODLs, became central to the grantees’ research projects and represent a significant, new category of patient-generated data.  Brennan also introduced a short video where members of each project team illustrated their projects’ findings and challenges.

Project investigator Katherine Kim described how her team’s iN Touch application helped young people struggling with obesity to become more engaged in managing their health and lifestyle.   Dr. Stephen Rothemich outlined findings of his team’s BreathEasy project, showing how ODLs can provide clinically useful information and in some cases can lead to changes in diagnosis or therapy. 

Finally, National Advisory Council member Dr. Michael Christopher Gibbons spoke eloquently of the critical role personal health records can play in a rapidly evolving society, where new approaches are needed to tend to the needs of a growing population of seniors, minorities, immigrants and the underserved.  

If you registered for the webinar but weren’t able to view it, follow this link and log in with the email address used at registration.

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.

Project HealthDesign and Patient-generated Data [Video]

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

Throughout Project HealthDesign’s history, our grantee teams have worked closely with patients in order to explore the potential of personal health records (PHRs) and personal health data. As our first nine teams worked on their projects, they listened closely to patients and began hearing patients describe their health in idiosyncratic ways. Their work led to the recognition of observations of daily living (ODLs) — information about an individual’s life that is both patient-defined and patient-generated.

Project HealthDesign's five most recent grantee teams have carried this vision forward by designing five different technical systems that allow patients to track their ODL data. In these projects, patient participants have tracked a variety of ODLs, from daily activity and stress levels to socializing and moods.

But ODLs are just one type of patient-generated data. Other types include traditional patient-reported information about signs and symptoms (e.g., blood pressure, blood glucose), sensor data, patient preference data, and patient-reported quality assessment data.

We’ve been excited to see interest in patient-generated data grow throughout the course of the program. This month, Patricia Flatley Brennan, Project HealthDesign national program director, testified before the HIT Policy Committee’s Meaningful Use and Quality Measures Workgroups and the HIT Standards Committee’s Consumer Engagement Power Team at their Patient-generated Data Hearing. (Listen to an audio recording of the hearing.)

“Patient-defined, patient-generated data can be incredibly important in helping to understand the care process of individuals,” said Dr. Brennan. Watch the video below to learn more about Project HealthDesign’s outlook on patient-generated data.

Project HealthDesign at Nursing Informatics 2012

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

Whether you’ll be attending the 11th International Congress on Nursing Informatics in person or watching the webcast from afar, keep an eye out for Project HealthDesign at NI 2012. Patricia Flatley Brennan, Project HealthDesign national program director, will give the closing keynote presentation on Wednesday, June 27 at 10: 30 a.m. EST. Uba Backonja, Project HealthDesign researcher, will present a paper titled “Observations of Daily Living: Putting the "Personal" in Personal Health Record” on Tuesday, June 26 at 10:30 a.m. EST. Co-authors include Kathy Kim, iN Touch principal investigator; Gail Casper, Project HealthDesign deputy director; Tim Patton, Project HealthDesign researcher; Edmond Ramly, Project HealthDesign researcher; and Patricia Flatley Brennan. The conference runs June 23-27 in Montreal, and attracts nurse informaticists as well as others interested in health IT. 

Learn more about NI 2012.
Follow the backchannel on Twitter at #imiani2012.

Project HealthDesign Director Testifies at Meaningful Use Workgroup Hearing

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

Today, Patricia Flatley Brennan, R.N., Ph.D., Project HealthDesign national program director, and Nikolai Kirienko, co-project director for Project HealthDesign’s Chronology.MD team, will testify at a hearing on the incorporation of patient-generated information to manage health. This hearing is organized by the Meaningful Use Workgroup of the HIT Policy Committee.

Brennan has been invited to testify on the business and technology of patient-generated data and its use in clinical care. Her written testimony (pdf) draws upon the experiences of all fourteen Project HealthDesign teams throughout the program’s two rounds of funding, as well as the teams’ interactions with hundreds of patients. However, she will focus mainly on stories and findings from Project HealthDesign’s five current teams.

Brennan’s testimony will focus on three main points:

1. We need to expand the idea of patient-generated data to include patient-defined data.
2. Sharing patient-defined data with clinicians improves the business of health care.
3. Existing technologies are adequate but not optimal for the clinical integration of patient-defined and patient-generated data.

Kirienko will draw upon the experiences of Project HealthDesign’s Chronology.MD team; he will also speak as an advocate for patient engagement in health and health care. His testimony will focus on the need for patient access to open APIs in the EHR and the need for standards for dynamic patient engagement on mobile devices.

Paul Tang, M.D., Project HealthDesign National Advisory Committee chair, co-chairs the Meaningful Use Workgroup, and Deven McGraw, J.D., M.P.H., a member of Project HealthDesign’s regulatory and assurance advisory group, is also a member of the Workgroup.

Listen to the webcast.
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Patient Engagement is the Hallmark of Patient-Centered Care

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

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

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

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

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

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

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

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

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

Read more health policy comments from Project HealthDesign.

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!

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.”

Patient Access to Lab Test Reports and the Era of Data-driven Health Care

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

As director of Project HealthDesign, a national program of the Robert Wood Johnson Foundation that aims to explore how personal health records (PHRs) and patient-sourced data might improve health and health care, I applaud this proposed rule. Allowing patients direct access to lab test reports is an appropriate and much-needed step toward equipping them to access, understand and act on their own health data. My work with Project HealthDesign has shown me that individuals are ready for an era of data-driven health care. Patients are hungry not only for access to lab test reports and clinical visit data, but also for access to more and different kinds of health data to use in conversations with their clinicians. We’re excited to see how patients, when equipped with their own health data, might share richer insights about their everyday health with clinicians and take charge of their health between clinical visits. That’s why we see this proposed rule as a big step for patients.

However, I also recognize that changing the flow of information is going to change the clinical conversation. Everyone needs to be involved in order to ensure that this process remains efficient and effective. That’s why I urge you to concurrently develop patient education tools that will allow patients to understand and minimally interpret lab test report data. At the same time, we must also work to prepare clinicians to participate in this new era of data-driven health care.

This comment was submitted to HHS in response to a proposed rule that would allow patients direct access to their lab test reports. To read the proposed rule, visit regulations.gov.

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Learn more about the proposed rule.
Read more health policy comments from Project HealthDesign.