Health 2.0 Recap, Part 1: The Conference

Robert Furberg, MBA, Ph.D., BreathEasy Text Messaging Pilot Lead, RTI International

The worlds of health and technology collided over in late September for the 2011 Health 2.0 Annual Conference in San Francisco, continuing the trend of impressive growth that reflects the accelerating pace of change in medicine. More than 1,500 people attended the conference, which boasts an agenda that included 100+ live technology demos, a dizzying array of corporately sponsored keynotes, deep dives, parallel tracks, and receptions. Amazingly, all of this was preceded by a week of code-a-thons, HealthCamp San Francisco, and a four-track pre-conference workshop (Health Law 2.0, Patients 2.0, Doctors 2.0, and Employers 2.0).

The first day kicked off with a general focus on high quality, low cost and connectivity. The event began with a presentation by Health 2.0 co-founders, Matthew Holt and Indu Subaiya, who provided a summary of how much the health care and technology landscapes have changed over the past few years and how the notion of Health 2.0 fits into the current state of health care. Dr. Mark Smith, president of the California HealthCare Foundation, suggested during the keynote address that, in order to attract the interest of investors and customers, products and services should address at least one of the pain points in the health care system. Numerous startups and joint ventures demoed throughout the day, with a large focus on mobile applications and the gamification of disease prevention and management.

The second day focused on how data liquidity can improve care and reduce health care costs. Topics included mobile applications, the Quantified Self movement, health behavior change, social media-based gamification, open APIs, and the availability of federal data sets. Even more startups and joint ventures provided demos and launch announcements throughout the day. A highlight of the day was the involvement of several federal representatives who were as engaged as the conference attendees.  Leaders from ONC, including Dr. Farzad Mostashari, Lygeia Ricciardi, and Jodi Daniel, held a town hall meeting to discuss the importance and ease with which patients can now access their electronic health record (EHR) data. The day ended with a pair of significant events that focused on patient and family engagement: first, a Patients 2.0 panel that featured ONC staff fielding questions on health data access that had been generated by patients during a pre-conference workshop and then an announcement that the Society for Participatory Medicine is seeking to certify 10,000 physicians as “patient-centered providers.”

Check back tomorrow for Health 2.0 Recap, Part 2: The Pioneer Portfolio Approach.

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Observations on Policy and Legal Issues

Sarah Bimber, J.D. and M.P.H. Student, Project HealthDesign Project Assistant, University of Wisconsin-Madison

In August, Project HealthDesign’s current teams met with the National Program Office and other advisers for a workshop that allowed the teams to collaborate in the midst of the evaluation phase of their projects. While the teams shared their successes and challenges, I noted several legal and policy topics and implications:

Policy and legal issues continue to underlie many aspects of Project HealthDesign’s work.

In Project HealthDesign studies, patients and caregivers partner together through the use of new technologies. This work raises a host of legal and policy issues, from data security to clinical licensing. Although policy and legal considerations were foundational to our discussion at the workshop, these issues often were not discussed explicitly.

Data security and privacy requirements remain challenging.

During the workshop, the teams identified how and when data is protected via encryption and/or password protection, as is required by federal law. We also discussed how the teams would respond if a mobile device were lost or stolen. The teams report that patients in their studies do not express concerns about potential losses of health data. One team reported that they could remotely wipe patient data from a lost or stolen device when the device is connected to WiFi. Informing patients about password protection options on their mobile devices may be the best option to alleviate these concerns.

The teams are exploring ways to incorporate patient-sourced data into clinical EHRs.

Several teams reported efforts toward utilizing an EHR to present a hyperlink, store a PDF report or communicate with clinicians. “Inclusion in an EHR” can mean several different things, but it can have legal consequences for clinicians and organizations. For example, if an organization considers the ODL data to be part the legal health record, it could be demanded during litigation.  A report of ODL data that is barcoded and stored in a document management system by a hospital is likely part of the legal health record, but communication with a clinician via an EHR-related secure email system may not be. Although none of the Project HealthDesign teams will be feeding patient ODL data into a provider EHR as discrete data elements, the program sees this as a goal for the future.

Project HealthDesign teams are customizing data views based on role and patient preferences.

In addition to designing a mobile application with meaningful data displays, several teams are also customizing data displays for clinicians and patients to account for clinicians’ preference to see data over time in concise formats. One team also reported limiting what providers may view based on patients’ preferences. This is in line with a vision for PHRs that empowers patients to control how and when their data is used. Another team addressed patient safety concerns related to limiting clinician data views by identifying that if a critical value is measured that may indicate an unsafe situation, a clinician alert is automatically triggered. 

The teams have involved a range of clinicians in ODL review workflows.

The teams varied in terms of the types of clinicians involved in their projects and the scope of involvement in review of ODL data. School nurses, health coaches, L.P.N.s, R.N.s and physicians are all involved in projects in some capacity. Because an M.D. is rarely the provider regularly reviewing ODL data, the workflows include a front-line provider that may escalate clinical issues to an M.D. If the front-line provider is responsible for triaging potential issues, he or she should have a scope of practice appropriate for this task.

Project HealthDesign teams are using messaging technology to provide reminders and decision support.

Several teams are using secure messaging technology to remind patients to enter ODL information or provide health-related information. Health text messaging can be a beneficial source of health education. Because health text messaging systems are relatively new, questions remain as to how best to integrate these systems with EHRs, address potential privacy and security concerns and build and share libraries of evidence-informed health information. The Project HealthDesign teams currently using messaging services may have some insights to offer.

If these observations spark additional questions, please share your thoughts with us by commenting below or on Twitter @PrjHealthDesign.

ONC Releases PHR Model Privacy Notice

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

As more individuals begin to use personal health records (PHRs) to manage their personal health information, it is important that they be aware of PHR companies’ privacy and security policies. This is something that we at Project HealthDesign know well. Because of a new PHR Model Privacy Notice (Model Notice) created by the Office of the National Coordinator for Health IT (ONC), we hope that others will soon appreciate the importance of knowing how PHR companies use their data.

ONC released the Model Notice on September 12, 2011. It is a standardized template that a web-based PHR company can use to inform consumers about its privacy and security policies. According to ONC, consumers should think of the Model Notice as similar to a nutrition facts label for food:  it succinctly provides important facts that consumers should know before using a PHR. The Model Notice is meant to provide information to consumers in a uniform format they can understand, compare and use to make an informed decision about which PHR they would like to use.

The Model Notice has two sections: (i) the “Release” section; and (ii) the “Secure” section. Both tell consumers what the PHR company may do with their data. The “Release” section tells consumers whether the PHR company releases their data and for what purposes (e.g., for marketing and advertising). It also describes any data release restrictions the PHR company may have in place and explains whether the PHR company will stop releasing a consumer’s data once they close or transfer their PHR. The “Secure” section includes three points to help consumers identify the PHR company’s data security practices. Specifically, it identifies that the PHR company implements security measures; whether the PHR company stores PHR data in the United States only; and whether the PHR company keeps activity logs that record who accesses a consumer’s PHR and when.

ONC was likely motivated to release the Model Notice, at least in part, because many PHRs are not covered by existing health information privacy laws and regulations (e.g., the Health Insurance Portability and Accountability Act’s Privacy and Security Rules). Thus, there are no clear rules for them to follow when handling consumers’ health information. This is a significant gap in the country’s privacy laws. Although voluntary use of a Model Privacy Notice will not solve the problem, it is a step in the right direction.

ONC released a helpful document titled, “Consumer Guide to Understanding and Using the PHR Model Privacy Notice on PHR Company Data Practices,” which does exactly what its title suggests. We recommend it for anyone who uses a PHR. Additionally, the PHR Model Privacy Notice is available for PHR companies to begin using.

Let us know what you think about the Model Notice. Does it include enough information to be helpful?  Would the participants in your projects be able to understand what it says?  Can you think of any ways that you can employ the concepts behind the Model Notice in your projects?

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Project HealthDesign at AMIA 2011 Annual Symposium

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office 

The American Medical Informatics Association (AMIA) 2011 Annual Symposium begins this weekend and runs Oct. 22-26 in Washington D.C. We congratulate BreathEasy Co-Principal Investigator Barbara Massoudi, who will receive a Leadership Award at the Symposium’s Leadership Dinner, for her success in advancing the association’s public health informatics activities.

Project HealthDesign Director Patricia Flatley Brennan will also attend the AMIA 2011 Annual Symposium. If you’ll be participating in the conference, we invite you to attend one of Dr. Brennan or Dr. Massoudi’s sessions:

Tutorial T05: Personal Health Records, Patient Portals and Consumer-Facing Health IT
Saturday, Oct. 22, 8:30 a.m. to noon
Patricia Flatley Brennan, University of Wisconsin-Madison; Jonathan Wald, Partners HealthCare System; Stephen Ross, University of Colorado Denver

Panel S60: The Role of the Clinician in a Patient Power Context
Tuesday, Oct. 25, 1:45-3:15 p.m.
Charles Safran, Warner Slack, Harvard Medical School; Patricia Flatley Brennan, University of Wisconsin–Madison; Sally Okun, PatientsLikeMe

Panel S68: The Next Informatics Agenda for Public Health
Tuesday, Oct. 25, 3:30-5 p.m.
Barbara Massoudi, RTI International

Learn more about the AMIA 2011 Annual Symposium.
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This post was updated Oct. 24 at 9 a.m. CST.

Report Details Teams’ Technical Architectures and Implementations

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

A new report from Project HealthDesign technical partners Sujansky & Associates details the technical architectures and implementations employed by each of the project’s five current research teams. For each team, the report describes which observations of daily living (ODLs) patients are tracking, the technologies the patients use to collect ODL data, how the resulting ODL data is interpreted by the teams’ technologies, and how patients and clinicians are able to review the ODL data.

The report concludes with an overview of patterns and lessons common across the five teams’ technical implementations, including observations about:

• Third-party platform integration
• Integration of ODLs with clinical systems
• Battery life
• Data caching on mobile devices

For a comprehensive overview of the teams’ technical architectures and implementations, read the full draft report, “Project HealthDesign: Technical Architectures and Implementations.”

For a quick overview of the teams’ technical architecture diagrams, view the presentation below:

Project HealthDesign -Technical Architecture Diagrams

 

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Report Illuminates Early Findings and Challenges from Project HealthDesign

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office 

Read the latest report from Project HealthDesign to learn what our five research teams have experienced as they’ve worked with patients to capture observations of daily living (ODLs) and integrate the resulting data into clinical care.

As mobile health apps and patient self-tracking movements continue to spread, the health and health care fields are ripe for innovation. Project HealthDesign explores how patient-sourced data might contribute a new richness to personal health records (PHRs) and patient-clinician interactions.

Project HealthDesign: Early Findings and Challenges

Early insights:

• Chronically ill patients are eager to try new technologies that help them take charge of their health.
• Each patient is different, so personal health applications need to be customizable.
• New clinical workflows are needed in order to incorporate ODLs into clinical practice.
• Reviewing ODL data can highlight day-to-day variation for patients and clinicians.

Early challenges:

• It’s not yet clear what the best approaches will be for storing ODL data.
• Privacy and security issues continue to be challenging.

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Examples Would Help Clarify When a Mobile Application Qualifies as a Mobile Medical Application

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

I want to thank the FDA for the opportunity to comment on the draft guidance on mobile medical applications. The guidance certainly aims to clarify what types of mobile applications qualify as mobile medical applications, what types qualify as mobile health or wellness applications, and what types qualify as mobile medical devices. The issue I want to be sure you address is that the line between mobile medical applications and mobile health or wellness applications is not yet sufficiently clear.

Through Project HealthDesign, our 14 research teams have developed mobile applications that allow patients with chronic diseases to manage their health in new ways. Beyond our project, many well patients are beginning to use mobile health or wellness applications to actively maintain their health. The language of this guidance must reflect this new reality when delineating between these two groups of mobile applications.

I also encourage you to provide more examples of the types of mobile applications that fall into each of these two categories. Developers must be able to easily identify whether their applications will be subject to regulation as mobile medical applications. Without additional examples of the types of applications that fall into each category, developers’ uncertainty about the guidance might stifle the incredible innovation we’re seeing in this space. Furthermore, I urge you to implement a transparent process for updating the list of examples over time as the technology evolves.

This comment was submitted to the FDA in response to their draft guidance on mobile medical applications. To read the draft guidance and submit your own comment, visit Regulations.gov. The commenting period ends Wednesday, Oct. 19.

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iN Touch Mobile Application Overview

Holly Logan, iN Touch Project Coordinator, San Francisco State University

We worked with TheCarrot.com team to customize a mobile application for iPod Touch and iPhone. Our participants have been using this personal health application to capture their observations of daily living (ODLs). Here is a sample walk-through of how a participant may interact with the app:

1. Participants in our study first sign in to the application on their iPod Touch devices.
   
   
   
   
2. After they sign in, they come to a homescreen that manages their trackers. Users could choose to manage a variety of trackers,  but for the iNTouch study, participants have been asked to keep track of four trackers: exercise, food, mood and socializing.
   
   
   
   
3. Let’s say this participant, Jim*, just got home for the day and wants to record his activities and observations. First he decides to record what he ate with his friends that day. To do this, he selects “Food” on the “My Trackers” page and comes to the screen below:
   
   
   
   By adding a food and then searching for it, Jim can easily record what he ate with his friends. Let’s say he wants to add strawberries. He can type the whole word or just part of the word into the search box below:
   
   
   
   Once he finds what he wants, he clicks the orange plus button to add the food to his folder. When he's done adding the foods he's eaten, he selects the green save button in the lower right-hand corner. When he hits the save button, he is sent back to the “My Trackers” page.
   
   
4. Jim may then decide he wants to record his mood for the day. When he selects “Mood” on the “My Trackers” page, Jim comes to this page:
   
   
   
   Let’s say Jim is stressed out and sad because he should have been doing his homework instead of hanging out with his friends, and now he has a lot to do and is running out of time. He is also feeling angry and unhappy about this situation. By touching the orange plus button next to each emotion, Jim adds these moods to his folder and comes to this screen:
   
   
   
   The green check next to each emotion means that Jim has added that emotion to his folder. The folder is located in the top left-hand corner, where it shows that he has added four emotions. Once Jim moves the sliding buttons to note how intensely he feels each emotion,  he can hit save in the lower right-hand corner, which takes him back to the main “My Trackers” screen.
   
5. Let’s say Jim also wants to track the amount he socialized that day. When he selects the socializing tracker, he comes to this screen:
   
   
   
   This screen operates much like the “Moods” screen. Jim  tracks how much he socialized, whether people influenced him negatively or positively and whether people supported him a lot or not much. Let’s say Jim decides he wants to add some personal details about his socializing experience, so he decides to write a note by clicking the “Notes” button on the lower part of the screen. He then comes to the “Notes” screen:
   
   
   
   On this screen, Jim can write a note about what he did with his friends; once he’s done, the green save button takes him back to to the “Socializing” screen:
   
   
   
   When he’s done entering his information, Jim can select the green save button to go back to the main “My Trackers” menu.
   
   
6. Finally, Jim remembers to  record his exercises from the night before in the “Exercise” tracker. When he selects “Exercise” on the main “My Trackers” menu, he comes to this screen:
   
   
   
   On this screen, Jim searches for his exercise and adds what he has done by hitting the orange plus button. When he adds running as an exercise entry, he comes to this screen:
   
   
   
   Because Jim is adding an exercise entry for the previous night, he needs to correct the date and time. When he selects the calendar image at the bottom of the screen above, he is taken to the screen below, where he can change the date and time before selecting the green save button (in the upper right-hand corner), which takes him back to the “Exercise” screen. 
   
   
   
   Once Jim saves his exercise entries and finishes recording his observations for the day, he can take a look at his progress by looking at his “Journal.” To get to the “Journal,” Jim clicks the notebook symbol at the bottom of the screen to review his “Journal,” which displays his progress.
   
   
   
   

Our participants seem to accept our app well, and they report that it is pretty easy to use and takes only a few minutes a day. We are doing exit interviews as participants complete our study, so we’ll be able to share more of their feedback in a future post.

*Jim is not a real participant in the iN Touch study.

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The Challenges of Locating Parents of Preterm Infants

Karen Cheng, Ph.D., Estrellita Co-Principal Investigator, University of California, Irvine

In the best of circumstances, it requires a whole lot of patience to recruit parents of preterm infants (born at <32 weeks gestational age). The parents are stressed, sleep-deprived, and may be caring for other children at home. We try to catch the parents in the Neonatal Intensive Care Unit (NICU) when they are visiting their babies. If we cannot find them there, we try to reach them by phone after their babies have been discharged from the NICU. We call and leave messages. We call and call again. For parents with stable jobs and stable home environments and who have active cell phones, we do eventually reach, well, some of them.

To complicate matters, we have been finding that a number of life factors make it even more difficult to reach and recruit these parents. There is the possibility of post-partum depression, for example, in the case of the mom whose voicemail inbox has been full for over a month. Some parents may have unstable home environments, as in the case of parents who do not have their own phone number and must be contacted through family members and friends; they may or may not live with these family members or friends, making it very difficult to pin down when they might be available at that number. And still other parents simply can no longer be reached at the numbers they gave the hospital upon discharge: in one case, the parent’s phone number stopped accepting calls within a few days of discharge.

Our colleagues at the Early Developmental Assessment Center (EDAC) face these challenges every day. EDAC and other high-risk infant follow-up programs across the country face overall attrition rates between 10-25%; rates are estimated to be nearly 50% for people of lower socioeconomic status. One key problem is the inability to reach parents to remind them to come in for appointments.

It’s a problem that appears deceivingly simple: contacting parents to tell them about the study or to remind them of their babies’ EDAC appointments. Yet it is surprisingly challenging and in the case of the EDAC appointment, it may have adverse effects on the babies’ health and development. Dini Baker, R.N., CHOC EDAC manager and Estrellita clinical partner, jokes about how nice it would be to give every baby a GPS tracking device upon leaving the NICU. I wonder if it might make it easier to contact the parents if U.S. cell phone plans allowed incoming texts or phone calls to be free – or if incoming texts or phone calls from certain phone numbers were free. For the parents whom we are able to contact and enroll in the study, our hope is that recording and sharing their babies’ ODLs with EDAC nurse case managers will increase their communication with EDAC and their likelihood of attending EDAC appointments, even after the study is over.

We’re continuing to wrestle with and brainstorm solutions for this problem. If you have any suggestions, we would love to hear them!

Learn more about the Estrellita (formerly FitBaby) project.
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Thinking about Science, Evaluation and e-Health Design

Linda Neuhauser, Dr.P.H., Crohnology.MD Co-Principal Investigator, School of Public Health, University of California, Berkeley

One of the big challenges we have faced in the Crohnology.MD project is developing an evaluation plan. We are all familiar with the trade-offs between using qualitative and quantitative methods. If we choose a primarily quantitative approach, we may have statistical results, but may not really understand the phenomena being tested. If we select a qualitative approach, it’s hard to know whether the results would be similar if tested on a larger cohort. This is the typical tension in evaluation design. My view is that traditional evaluation methods are not well suited to novel e-health experiments, like the Project HealthDesign projects. I’ll start with a personal story:

Last March, I participated in a conference on Artificial Intelligence and Health Communication at Stanford University. There were many fascinating state-of-the-art projects. I was especially intrigued by a project using avatars as health coaches. The developers described how they gathered some preliminary (formative) information at the project outset, implemented the project, and then quantitatively evaluated the outcomes. The developers and the funder considered this an acceptable design, as would many evaluators. However, the results uncovered an important problem—the users did not find the avatars adequately believable and that interfered with their engagement with the virtual coaching. Similar surprises cropped up in other projects that were presented, even though the developers of the projects were highly talented, had given careful thought to the evaluation, and had used both qualitative and quantitative methods. As a result, a number of these projects will now need to be re-funded, redesigned and re-evaluated. I left the conference with the strong impression that some of these problems could have been avoided if the developers had used different evaluation methods. Certainly, e-health evaluation is an area that needs a lot more attention.

I believe the roots of the evaluation conundrum lie in the foundations of scientific inquiry. Before the mid-20^th century, the dominant “positivist” view was that truth is knowable and generalizable and the focus was on discovering the laws that govern the physical world. This perspective advanced the idea that quantitative methods (like randomized controlled trials) should be the gold standard of research and that their findings could be broadly extrapolated. In the past 50 years, the scientific paradigm has shifted. In the “post-positivist” world, the “critical realists” have emerged and posit that it is impossible for humans to adequately perceive the real world, and that claims about reality must be subjected to the widest possible examination.

There is now a greater understanding that it can be very difficult to define what we want to study, much less quantify the results. This is particularly true when we move from the natural sciences to human sciences—people don’t follow the more predictable laws of the physical world. In the health arena, we now have a host of social sciences to help us understand the connections between people and health. Changes in evaluation design have paralleled changes in views about scientific inquiry. Qualitative methods are considered increasingly important to achieve a deeper understanding of the complicated nature of human health and behavior. Likewise, there is a growing recognition that formative work needs to take place before investigators even know enough to finalize a research design that focuses on outcomes.

Scientists have identified a newer research challenge: one posed by what is now called “design (or artificial) sciences.” This field is concerned “not with how things are, but with how they might be.” (Simon, 1996).  Those who study design sciences say that they pose special challenges for research methods because understanding a problem and solving that problem often happen at the same time. Similarly, there is no “end” to the design and problem-solving process. Obviously, design science efforts are not well suited to traditional research approaches that test a priori hypotheses. For this reason, design sciences emphasize real-time, iterative investigative approaches, such as usability testing, over the more simplistic “before” and “after” methods of traditional evaluations. In other words, just as we are experimenting with observations of daily living (ODLs) to get finer, time-sensitive information about participant data, we need to do the same in our evaluations.

In my view, the Project HealthDesign projects, which create new technologies and measure complex daily interactions between people, their environments, and their health, lie at the intersection of human and design sciences. Effective evaluation designs for these projects will need to include a strong focus on usability and other iterative testing over time, artfully linked with formative and outcome measures. There is no definitive guidance for such evaluation designs. Fortunately, the Project HealthDesign teams have taken a pioneering experimental approach to finding a better path forward.

Have you successfully employed both quantitative and qualitative evaluation techniques on a project? What advice can you share with us?

Reference:
Simon, H. 1996. The Sciences of the Artificial, 3^rd Ed. MIT Press.

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