1. RTI International RTI International is a trade name of Research Triangle Institute. www.rti.org Patient-Generated Health Data Exploring its definition and impact on care delivery and health IT”

2. RTI International Diabetic Tester that talks to iPhones and Doctors Mossbert W. The Wall Street Journal. 2012 January 5. Available at: http://online.wsj.com/article/SB10001424052970203513604577140830225124226.html http://online.wsj.com/article/SB10001424052970203513604577140830225124226.html

3. RTI International As Smartphones Get Smarter, You May Get Healthier: How mHealth Can Bring Cheaper Health Care To All Bluestein A. Fast Company. 2012 January 9. Available at: http://www.fastcompany.com/magazine/162/health- industry-smartphones-tablets.http://www.fastcompany.com/magazine/162/health- industry-smartphones-tablets

4. RTI International Overview  The Office of the National Coordinator for Health IT requested a focused analysis of patient-generated health data (PGHD) to: – Describe and define PGHD – Understand current state and anticipate future directions  RTI conducted: – A brief environmental scan including:  Informal discussions with key experts including patients  Selected literature & website review  Participation in a “listening session” at HIMSS 2012

5. RTI International Research Questions  How should PGHD be defined?  What are the primary technical, legal, operational and other issues?  Who has identified and attempted to address these issues?

6. RTI International Scenario 1 - Hypertension Jane Hart is pre-hypertensive and her primary care provider (PCP) asked her to track her blood pressure (BP) twice a day. Jane purchased a BP cuff in a retail outlet and records her BP in her daily log (on paper). Each week, Jane sends the readings via secure email to her PCP. Jane takes BP at home (twice daily) Jane records BP using paper log (twice daily) Jane emails readings to her PCP (weekly) PCP reviews BP readings (weekly?) Data Capture Data Transfer Review/Document

7. RTI International Scenario 2 - Diabetes Jack Sprat has diabetes and is trying to improve his diet. To help determine if his diet is “working”, he purchased a glucometer to watch his blood sugar level, and signed up for a PCHR (patient-controlled health record) offered by My-Health-eMe (MHM). Using the glucose tracker app on MHM, he transfers data from the glucometer to his laptop using a standard USB interface cable. The tracker app saves his glucose measurements over time, allows him to add notes about his meals, compares his latest data to previous weeks’ data, and creates a summary for his next PCP visit. Jack’s glucometer records glucose before meals Jack uploads data to MHM Jack adds meal notes using tracker app Jack shares summary with PCP at visit Data Capture Data Transfer Review/Document

8. RTI International Scenario 3 - Asthma Louise has chronic asthma and her pulmonologist is anxious to help her avoid another ER visit. She agreed to use a special new inhaler with built-in monitoring capabilities. When Louise uses the inhaler, her provider will know. Medication data, patient ID, location data, time and dosage goes directly into an asthma database for the provider to review, and possibly to add to Louise’s medical record. Louise uses wireless inhaler with automated data capture (as needed) Inhaler data transmits to “cloud” database (2x/day) Provider reviews inhaler data (timing?) Data Capture Data Transfer Review/Document

9. RTI International Flow diagram for PGHD Data Capture Data Transfer Review/Document

10. RTI International How should PGHD be defined?  PGHD definition – Health and medical data – including disease history, symptoms, physiology, treatments, lifestyle, and other information – created, recorded, gathered or inferred by or from patients or their designee  Patients, not providers, are primarily responsible for capturing or recording these data.  Patients control sharing of data to health care providers and others.  Distinct from: capture and flow of health and medical data as directed by providers.  PGHD context – Advances in data-driven medical science, EHRs, the internet, and mobile technology are enabling rapid and substantial growth of PGHD – Data capture/flow may be partially, fully, or not-at-all automated – Highly varied capture/flow processes are relevant  Different: devices; conditions; provider expectations; data types and timing, etc.  Patient motivations include: self-care, seeking advice, responding to requests – No guarantee of participation or consistent use among patients  Access, usability, technology, educational, health literacy, economic, etc. barriers

11. RTI International Operational questions  Operational – Capture/Transfer  What will motivate people to participate? What barriers should be removed to enable flow? How is a person informed, trained and supported?  What (patient-side) technologies support PGHD? – Review/Document  What will motivate providers/staff to participate? What barriers should be removed to enable flow?  What existing (or new) review processes are needed? How will they scale?  What (provider-side) technologies support PGHD?

12. RTI International Technical, Legal questions  Technical – What safeguards, standards, authentication, interfaces, and data types/definitions are needed?  Legal – What existing (or new) liability is there? How are expectations set and communicated?

13. RTI International More Information Michael Shapiro Senior Health Informaticist 312.777.5227 mshapiro@rti.org Jonathan Wald Director, Patient-Centered Technologies jwald@rti.org