If Specificity Is the Solution, ODLs Are Key

Sara Koliner, Policy Analysis Project Assistant, Project HealthDesign National Program Office

Mobile apps have proven to be valuable tools for collecting ODLS in this last round of Project HealthDesign. While the benefits are clear, however, creators of mobile apps must contend with a complicated interplay of safety, cost, usability, and accessibility in order to produce high quality software. Weakening these foundations can lead to misuse by consumers, or rejection by practitioners. On the other hand, overabundance of requirements can stall progress and hinder the utility of these applications.

A few weeks ago, the Healthcare Information and Management Systems Society (HIMSS) held its 13^th annual conference in New Orleans, LA. In one notable e-session, presenters Katharina Steininger and David Rückel outlined the values of key stakeholders in mobile health applications, and thus the priorities that should be used in applications themselves. A copy of their slideshow is available here.

In “Mobile Health Applications—Strategic Stakeholders’ Perspectives,” Steininger and Rückel name key stakeholders in mobile health applications: patients, practitioners in private practices, emergency medical services and mobile homecare, hospitals and nursing homes, application developers, and statutory and private health insurances. While the stakeholders often have common aims such as higher quality care and improved security, their priorities are unique and often contradictory.

The solution here is specificity: choose your stakeholders, and this will define your priorities. While the presenters describe doctor-to-patient and doctor-to-doctor style applications, they leave out the most relevant setting: patient-to-doctor communication.

Project HealthDesign teams inherently centered themselves around patients by designing mobile apps to use the data that embodies specificity: ODLs. By incorporating Observations of Daily Living, developers automatically look to the values of patients, and so produce a more effective application. Applications like BreathEasy even provided a separate dashboard for clinicians, allowing both the smartphone and computer-based portals to serve the exact needs of targeted users.

A final note on the importance of specificity: On Tuesday, March 19, the Energy and Commerce Committee hosted a hearing regarding the regulation of mobile health applications. In view of whether mobile health applications should be considered medical devices, gray areas indeed exist in applications that intend to replace monitors already used in the clinical setting. Applications dedicated to the capture of ODLs, on the other hand, add entirely unique patient-defined and patient-generated data to the workflow. The specifically non-clinical nature of ODLS requires a different framing of the quality question—one that addresses both the reliability from the patient’s perspective and accountability on the part of the clinicians. If quality standards are to be applied to this type of mobile app, they will have to be quite different from the standards currently used for clinical care metrics: if not necessarily relaxed, they must account for the idiosyncrasies of data shaped at the level of the individual.

Ingenuity and flexibility are essential to the development of quality mobile applications. As long as developers remain keyed into the patient perspective, they should be encouraged to use these faculties as effectively as possible.

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

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

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

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

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

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

Mobile Device Studies: Tips for Maintaining the Project Manager’s Sanity

Rita Sembajwe, BreathEasy Project Manager, and Barbara Massoudi, BreathEasy Principal Investigator

Research studies and other projects utilizing mobile devices frequently experience specific challenges related to mobile accounts and billing. As part of Project HealthDesign’s BreathEasy study, RTI International obtained smartphones and service plans for the 30 participants and several spare phones for project staff. We’d like to share a few tips for others undertaking research with mobile devices:

Cancellation Fees
Mobile phone service contracts typically include a set term of service, often a period of 24 months. Many research projects don’t run the full length of the contract period, leaving researchers to pay cancellation fees for the accounts at the end of the study. Our provider included fees at a flat market fee of $325, which was discounted by $10 for every month of service already paid through the contract. Multiply this amount by 30+ phones, and the project would pay thousands of dollars in cancellation fees. What’s the solution? Try to negotiate cancellation fees up front as you bargain with multiple service providers. Mobile service providers often say that their cancellation fees are the one thing they cannot negotiate, but it may be possible to negotiate these fees at the corporate level, rather than the project or individual account level.  Negotiating cancellation fees at the corporate level will benefit any project conducted under your organization’s corporate agreement. You could also get your service provider to approve a transfer fee waiver for accounts being transferred to participants after the end of the study or to other research projects within your organization. An organizational registry of current and upcoming projects using mobile devices could help facilitate these types of contract transfers.

Service Provider Support Issues
The phones we purchased for the BreathEasy project were supposed to have been unlocked at purchase to allow us to easily download the BreathEasy application, but this was not the case when we received the phones.  It ended up taking several weeks of working with the service provider to unlock the phones, and even then we sometimes had to research workarounds to get the BreathEasy app on the phones. This issue cost the project unanticipated labor and contributed to a delay in field activities. So what’s the solution? Projects involving mobile devices should get assurance from the service provider that all devices will allow third-party applications to be downloaded. If you include this stipulation in your contract, the burden of unlocking the phones will be on the service provider, not on your project staff.

Billing Issues
For several months, we experienced problems getting the mobile service invoices routed to the correct project within our organization. At times, our project was billed for mobile service accounts that didn’t belong to us. Other times, overage charges and reimbursements from the mobile service providers didn’t reach us until months later. A good solution would be to ask your service provider to move your project’s service charges to its own sub-account (called a billing account number, or “BAN”). This allows the service provider to directly assign all bills to the project’s account number, eliminating the need for manual routing of phone invoices within an organization.

We hope these tips assist you when planning and conducting your next research study using mobile devices.

Learn more about BreathEasy.
Read more posts from the BreathEasy team.

The iN Touch Approach to Device and Data Security

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

When we issued iPod Touch devices to participants, we knew some would be lost or stolen. We installed the Find iPhone application on each device that would allow us to locate a missing device, send messages, lock or wipe it.

The first time a participant came to us to inform us that their iPod Touch had been stolen, we took the necessary precautions: we locked it right away, sent a message to the iPod Touch indicating it was now stolen property and waited for it to hit Wi-Fi so that we’d be able to locate it. That was the catch. In order to be able to locate or wipe the device, it had to connect to Wi-Fi. And to throw in another step, when you choose to remote wipe the device, you can no longer locate it. So you have to take your chances here and work with the participant to see if they think they will be able to ask around and locate it, or think of who could have taken it and from where, etc. That was where it was tricky: Was it really stolen and gone forever, or was it temporarily misplaced?

When our first “situation” arose, the health coach had only spoken with the participant, who had said it was stolen. We decided to lock the device remotely and wait for it to hit Wi-Fi. In the meantime, we met with the participant to see what they thought about the device’s status. We asked “Do you know who stole it? Do you think you will be able to get it back?” When we determined that the participant knew who had stolen it, that they were adamant that they would never be able to retrieve it, and that they did not feel comfortable accusing the person, we decided to remotely wipe all data from the device.

However, we followed another process if we had reason to believe that the iPod Touch was simply lost, because we knew we might be able to recover the device. This happened with one participant who called and told us she had lost her iPod Touch after a day of running errands. She had searched her house high and low and looked in her car. The last place she remembered having seen it was when she was at Target.  I immediately locked the device and sent a message to it, which indicated that it was lost property and needed to be returned. Luckily the iPod Touch was going in and out of Wi-Fi, so I was able to see the location. When I told her the location, it turned out it was at her address. I asked her whether a neighbor could have taken it, or if she could have left it in her car. I had her go into each room and listen as I triggered a sound on her device. She still couldn’t find it. She decided to check her car, and I continued to play the sound. She finally heard it and found it jammed under the passenger seat of the car.  Thankfully, we had decided to search for it before remotely wiping it, otherwise all of her data would have been gone forever. When a device was reported lost, we decided it was important to give it at least a week to try to locate it. After that time, and if it was still lost, we decided it was a good idea to remotely wipe it as a security measure.

Unfortunately for all of the participants whose iPod Touches were stolen, none of them were returned, and we ended up wiping them all once they hit Wi-Fi. In each instance, the Find iPhone app has turned out to be a valuable tool that allows us to take the right steps to ensure the privacy and security of the participant’s health data and to  help the participant locate their device.

Images courtesy of Find iPhone app

Using Cell Phones to Improve the Health of Babies and Children Around the World

Karen Cheng, FitBaby Co-Principal Investigator, University of California, Irvine

One of the things I love about our project and the other Project Health Design projects is the creative use of cell phones to collect data and share health information. Cell phones have so much potential to expand access to health care for people who, for any number of reasons (e.g., lack of health insurance, distance to a health facility, unsure when it is appropriate to go see a doctor), might have limited access.

I recently learned of an organization operating in the West African country of Mali that uses some of the same methods we use in FitBaby. Like our project, Pesinet is committed to the early detection and prevention of illnesses among babies and young children. The similarities between our projects show the power of mobile technology to improve health for children around the world. The differences highlight the stark contrasts between our problems and needs here in the U.S. and the problems and needs in West Africa.

FitBaby focuses on infants who are highly at risk for long-term chronic illness because they were born pre-term. Pesinet works with infants and young children (up to age five, 20 percent of whom do not live to see their fifth birthdays) in Mali — almost all are high-risk because of the poverty and lack of health care in the country.

Both projects use cell phones to record health information about the children and then transmit the data via the cellular network to a central database, where health care professionals can access the data and review it for concerns. In the FitBaby project, we offer smartphones to parents so that they can record weight, diaper use, fussiness and other ODLs in the convenience of their homes. Parents can use the data to help determine if they should contact a health care provider about their baby’s health. A nurse case manager may also contact parents if she or he is concerned about the baby’s health indicators. Pesinet sends trained health care workers to families’ homes weekly to assess weight, diarrhea, fever, vomiting and cough (learn more). The health care workers use a cell phone to record data, transmit the data to a central health facility and receive feedback about whether the family should take the child in for further medical evaluation.

I find it thrilling that cell phones can be used in similar ways all around the world to serve the health needs of babies and young children. Best wishes to the folks at Pesinet! May your work be successful in improving the health of thousands of babies in Mali!

Learn more about the FitBaby project.
Read more posts from the FitBaby team.