1. Intelligent Health Lab Personally Controlled Health Records and the App Store for Health Kenneth D. Mandl, MD, MPH Director, Intelligent Health Laboratory Children’s Hospital Informatics Program Harvard Medical School Center for Biomedical Informatics

2. Intelligent Health Lab $2.5 Trillion 17% GDP Low return on investment 24th Life expectancy at birth 29th Infant mortality 37th System performance 1/3 spent on activities that do not improve patient outcomes Inconsistent use of effective interventions

3. Intelligent Health Lab US Spending per capita vs. Life Expectancy

4. Intelligent Health Lab Biased Evidence—two examples Publication bias Negative studies aren’t published Industry funded trials Are less likely published within 2 years of completion Are more likely to publish reported favorable outcomes Annals of Internal Medicine 2010

5. Intelligent Health Lab As per the National Coordinator... New England Journal of Med 2008: Low uptake of HIT in ambulatory setting New England Journal of Med 2009 Low uptake in of HIT in hospitals Conclusion: $48B investment, pushing the technology

6. Intelligent Health Lab Cap applies for any eligible professional with at least $24,000 in Medicare Part B allowable charges in each payment year Medicare Meaningful Use Incentive Payment Schedule

7. Intelligent Health Lab The Goal: A Learning Health System

8. Intelligent Health Lab But investment is in current stage technologies: No data in or out, no communication, terrible UIs

9. Intelligent Health Lab March 1, 2009 “There’s no way small practices can effectively implement electronic health records on their own.” “This is not the iPhone.”

10. Intelligent Health Lab Later in March

11. Intelligent Health Lab $15M ONC-FUNDED RESEARCH PROJECT

12. Intelligent Health Lab Clinical use case 1 Med-tastic is a well-funded NewCo which has developed an elegant medication list application that has physician and consumer facing functionality To work, Med-tastic needs  Prescribing history  Dispensed medication history  Allergies  Problem list diagnoses

13. Intelligent Health Lab Use case 2

14. Intelligent Health Lab Domestic Abuse British Medical Journal 2009

15. Intelligent Health Lab Use case 2 (cont) The application would require Comprehensive diagnostic data from primary site of care for each patient (to work well) Comprehensive diagnostic data from all sites of care (to work very well)

16. Intelligent Health Lab MedTastic may be able to develop apps adapted to several APIs (Cerner’s Mpages etc) Academic group cannot. THEREFORE, focus is on an API that enables a single apps store for Cerner Install Hospital with homegrown system Physician practice Open source EMR

17. Intelligent Health Lab We imagine EMRs as an iPhone-like platform where Medtastic could create and widely distribute an app across many disparate EMRs

18. Intelligent Health Lab EHR as an “iPhone-like” Platform There is a common application programming interface that enables Software developers to build SUSTITUTABLE applications  Push innovation to the edges  Nimbly evolve functionality  Avoid vendor lock  Shrink switching costs  Enable disruption

19. Intelligent Health Lab Our vocabulary: Data Sources (managed by containers) Containers (present data from data sources to apps in a uniform fashion) Apps (completely substitutable)

20. Intelligent Health Lab Substitutability works both ways— the containers can also be swapped out

21. Intelligent Health Lab Governance code: open-source, open formats, led by SMArt team app store: one app exchange to start, but others can be built. Installations manage their app gallery. Users manage their dashboards. brand: compliance test to ensure that “SMArt” is meaningful

22. Intelligent Health Lab “App Store” The SMArt App Exchange will feature apps approved by the SMArt committee Other organizations can operate and vouch for alternate app exchanges Each SMArt container installation will decide which apps it wants to feature in its App Gallery Each user may select his preferred apps placed in his App Dashboard

23. Intelligent Health Lab It is not the wild west

24. Intelligent Health Lab

25. SMArtPlatforms.org SMArt Health App $5,000 Challenge Announced by Aneesh Chopra during keynote with Bill Gates at mHealth last week Opens in March and allows innovation in MODULAR functionality Imposes discipline on us to create version 1.0 of the API Judges:  Regina Herzlinger (Harvard Business School)  David Kibbe (AFP)  Doug Solomon (IDEO)  Edward Tufte (Yale)  Jim Walker (Geisenger)

26. Intelligent Health Lab NEJM 2008 Ecosystem

27. Intelligent Health Lab “ We cannot overstate how important PHRs are to the efficient functioning of a low-cost, high quality health-care system.... We think that the INDIVO system, or something like it is a good place to start.” --Clayton Christensen Harvard Business School 2009

28. Intelligent Health Lab Will disruptive innovation be or fostered in healthcare

29. Intelligent Health Lab Looping in the Patient

30. Intelligent Health Lab In 1994 we observed that institutions rarely share data H1H2H3 xx Proprietary Perceived competition Privacy Health Insurance Portability and Accountability Act No dedicated resources to do so

31. Intelligent Health Lab What if we gave patients a tool to request their records electronically? H1H2H3 xx Indivo Server

32. Intelligent Health Lab And create a personal health record H1H2H3 xx Indivo Server Comprehensive record

33. Intelligent Health Lab The collection of these records is a population health database H1H2H3 xx Indivo Records Indivo Server

34. Intelligent Health Lab Intelligent Health Lab | Children’s Hospital Informatics Program Our original statement on personal control A PCHR stored all of an individual’s medical history in a container with: patient control interoperability open standards rules to protect patients

35. Intelligent Health Lab Patient role Patients can access the record grant access to others  specific to their role  of selected portions of the record store their record in a location of their choice annotate in the record (but not delete) grant access to “apps” and to devices

36. Intelligent Health Lab NEJM 2008 Ecosystem

37. Intelligent Health Lab

40. “ We cannot overstate how important PHRs are to the efficient functioning of a low-cost, high quality health-care system.... We think that the INDIVO system, or something like it is a good place to start.” --Clayton Christensen Harvard Business School 2009

41. Intelligent Health Lab

42. New England Journal of Medicine 2008 Tectonic shifts: PCHR vendors and users create large accessible populations for public health study and intervention

43. Intelligent Health Lab Individual contributions are accurate JAMIA 2007

44. Intelligent Health Lab JAMIA 2007

45. Intelligent Health Lab Patient vs. Doc Reports Basch The Missing Voice of Patients in Drug-Safety Reporting NEJM 2010

46. Intelligent Health Lab Individual contributions to drug safety data Patient reported outcomes Adverse effects Efficacy endpoints Adherence Satisfaction Quality of life Patient reported data Over the counter meds Complimentary/alternative meds

47. Intelligent Health Lab THE GENOMICS APP

48. Intelligent Health Lab

49. “What ever will we think about now that the genome project is complete ?”

50. Intelligent Health Lab Genes Environment Microbiome Phenotype Healthcare NEED LARGE N NEED data capture at home and in clinics

51. Intelligent Health Lab Phenome-Genome Database (PGD) Standard Biorepository 1.Static phenotype 2.No return of research results to patients 3.No patient engagement

52. Intelligent Health Lab Disintermediation ( MD’s not required )

53. Intelligent Health Lab Dangers of Large N and small p(D)

54. Intelligent Health Lab Why consent? Without consent: Tend to be stuck with anonymized datasets which are often cross-sectional and single purpose Impedes study of phenotype over time Tend to lose the opportunity to follow-up with the patient (public health imperatives are an exception) Risk privacy backlash

55. Intelligent Health Lab Tectonic shifts in the health information economy: Enabling inference across the data of PCHR users Population Database

56. Intelligent Health Lab The Gene Partnership Science 2007

57. Intelligent Health Lab The necessary compact entails complexity WSJ 2010

58. Intelligent Health Lab www.smartplatforms.org www.genepartnership.org www.indivohealth.org