From strategy to user interface to operational code, the best solutions are often found in the open-source design model which is consistent with the philosophy of sharing best practices and innovations in care delivery to improve health, with benefits for individual patients as well as the entire population.

1. v.51, 18.Jan.23
Own Your Healthcare Experience
An Open Source Path
Juhan Sonin

2. goinvo.com
Design Studio
MIT
2.009 Product Design

3. Disclosures
Blind-ishTrust
No involvement in investments since 1995
AcademicAppointment @ MIT
Own $2M/yr business
55% of revenue from commercial,45% from org + gov
Patents & personal health data are licensed
under open source

4. juhan@mit.edu
@jsonin

5. Medicine is a noble profession.
Sir
Th
omas Browne,1635
Healthcare is a noble business.
CIO,Boston-based Hospital,2022

6. Yes, it is noble.
And there are plenty of blisters
using that nobility ethos as cover,
as a shield, to obscure their activities.

7. 25%
healthcare GDP
Juan Enriquez
1 sq mile

8. 1%
of Global GDP

9. Follow the money.
It’s a systemic
fl
aw…
pro
fi
ts over people.

10. Jose Baselga
Chief Medical O
ffi
cer
Sloan Kettering Cancer Center
https://www.propublica.org/article/doctor-jose-baselga-cancer-researcher-corporate-
fi
nancial-ties

11. AnAssault on Ethics
Broke hospital Con
fl
ict of Interest rules:
Board/advisory roles with Roche + Bristol-Myers Squibb
Ownership stake in cancer therapy startups
Payments received from companies connected to cancer research in his articles
(published by Cancer Discovery,of which he was one of the two editors in chief)
Public positive spin on two Roche-sponsored clinical trials (without COI
recognition that for the past 4 years,he’s received $3+MM from Roche)
https://www.propublica.org/article/doctor-jose-baselga-cancer-researcher-
corporate-
fi
nancial-ties
Modeled after
Arthur Sackler

12. Making the rich, richer
Patient data owned
by hospital
100s of clinicians
encoded/decoded/
researched the data
Paid for by the public

13. Again, patient data
owned by hospital
Work by many, paid for
by grants
Th
e Gold Rush in the
land of non-pro
fi
ts
No competitive bidding
before licensing the data
to a single company,
Paige.AI

14. Hiding in plain sight
Data Use Agreement
keeps patients out of
control

15. What kind of design is this?

16. Hospitals own the data
Patients have no ownership rights
IP,patents owned by executives
Funded by the public
Abuse of public funding for private gain
Corporate welfare
Th
e rush for $$ over everything else
Ethics as situationally optional

18. Tal Zaks, Moderna CMO Michael Milken
“I have only 2 competitors in this race:
the virus and the clock.”
15.May.2020
on the Milken Institute Podcast
“18 years in training and being a physician… why was I going to industry?
When you open up a drug label, that are on the white labels [of the medicine], those
don’t say they were made at the National Institutes of Health.
Th
ey don’t say they
were made by the US government.
Th
ey said they were made by private industry…
I would be 1 or 3 logs more e
ff
ective if I went to industry versus staying in academia.”

19. Tal Zaks, Moderna CMO
$108M
since 2020-2021

20. https://www.cnbc.com/2022/03/10/moderna-ceos-golden-parachute-soared-by-hundreds-of-millions-over-the-pandemic.html
$923M

21. We are complicit.
We, United Statesians and global citizens,
are sloughing data everywhere,
without rights,
and it feeds Kendall Square,
Mountain View, and Moscow.

22. Health data includes more than you think.
1.

23. Health Data is any information
about a person’s life
that assists in making decisions
about health and wellness.

24. Health Data is

28. Determinants of Health.org

29. You don’t own your health data.
And you should.
2.

30. General Data Protection Regulation
(GDPR)

31. GDPR
Recital 7
1.
Th
ose developments require a strong and more coherent data
protection framework in the Union,backed by strong enforcement,
given the importance of creating the trust that will allow the digital
economy to develop across the internal market.
Natural persons should have control of their own personal data.
Legal and practical certainty for natural persons,economic
operators and public authorities should be enhanced.
“Control” and“access”
Ownership…

32. GDPR
Recital 63,Right of Access
1. A data subject should have the right of access to personal data which have been collected concerning him or her,and to
exercise that right easily and at reasonable intervals,in order to be aware of,and verify,the lawfulness of the processing.
2.
Th
is includes the right for data subjects to have access to data concerning their health,for example the data in their
medical records containing information such as diagnoses,examination results,assessments by treating physicians and
any treatment or interventions provided.
3.Every data subject should therefore have the right to know and obtain communication in particular with regard to the
purposes for which the personal data are processed,where possible the period for which the personal data are processed,
the recipients of the personal data,the logic involved in any automatic personal data processing and,at least when based
on pro
fi
ling,the consequences of such processing.
4.Where possible,the controller should be able to provide remote access to a secure system which would provide the data
subject with direct access to his or her personal data.
5.
Th
at right should not adversely a
ff
ect the rights or freedoms of others,including trade secrets or intellectual property
and in particular the copyright protecting the software.
6.However,the result of those considerations should not be a refusal to provide all information to the data subject.
7.Where the controller processes a large quantity of information concerning the data subject,the controller should be
able to request that,before the information is delivered,the data subject specify the information or processing activities to
which the request relates
Your data does not
belong to you.
It should.

33. Who Uses My Health Data .com

34. “the age of healthcare surveillance”
2000-2022
Does patient data ownership turn
into a net positive?

35. “…individuals might have control
over their personal data, so that
‘‘a person’s data would be
equivalent to their ‘money.’ It
would reside in an account where
it would be controlled, managed,
exchanged, and accounted for just
like personal banking services
operate today.’’
Alex Pentland @ World Economic Forum16
in 2006-2007
Healthcard, w/Data Ownership

36. … in 2005

37. “Patients should own their data.”
Elizabeth Nabel in 2017
Former President of Brigham Health
and
Seema Verma in 2018
Former Administrator of Centers for Medicare &
Medicaid

38. a side note…

40. I am dirty.
I’ve worked…
on risk adjustment for 1/2 the US,
with Rx that impacts 1/3 of prescriptions,
on national CMS guidance,
on screwing up US interoperability…
Apple
MITRE
MIT
NCSA

41. But there is a spectrum of dirtiness.

42. back to owning your data…

43. The Pathway to Patient Data Ownership
and Better Health
Digitalhealthdataarerapidlyexpandingtoincludepa-
tient-reportedoutcomes,patient-generatedhealthdata,
and social determinants of health. Measurements col-
lectedinclinicalsettingsarebeingsupplementedbydata
collected in daily life, such as data derived from wear-
ablesensorsandsmartphoneapps,andaccesstoother
data, such as genomic data, is rapidly increasing. One
projection suggests that a billion individuals will have
theirwholegenomesequencedinthenextseveralyears.1
These additional sources of data, whether patient-
generated, genomic, or other, are critical for a compre-
hensive picture of an individual’s health.
Enabling access to personal health data, clinical
or patient-generated, may benefit patients and health
careprofessionals.Researchisbeginningtoshowthatpro-
viding patients with their complete health data may
help improve their health. For example, timely access to
laboratory results can increase patient engagement.2
Accesstophysiciannotesafterappointmentsappearsto
encourage individuals to improve their health and par-
ticipate in decision-making, with electronically engaged
patients demonstrating more successful medication ad-
herence,qualityoutcomes,andsymptommanagement.3
Economic benefits may include the avoidance of dupli-
cative imaging or laboratory tests.4
Clinicians may also
benefitfrommoreinformedpatients.Forexample,they
may score higher in quality performance programs be-
cause patients who are more informed may better ad-
heretotreatmentplansandhencemayimproveclinician
scores. Despite growing evidence of such benefits, al-
beit with limited patient outcomes, and legislative and
regulatoryinitiativesthatfacilitateelectronicpatienten-
gagement, patients’ access to a complete, longitudinal
digitalhealthrecordremainsrare.Whilesuchaccessmay
be possible for certain patients who receive care within
a few select health systems, it remains elusive for many
others, including patients who have changed physi-
cians,livedindifferentplaces,havemultiplechroniccon-
ditions, or who have had services provided outside of
a clinical setting such as through a home health service.5
Health care, under pressure to embrace interoper-
ability,ispoisedfortransformation.Thepotentialforfu-
turesystemimprovementsisvast,butdepends,inpart,
onincreasedpatientparticipation.Healthcaremustfind
awaytoshiftfrom“thedoctorwillseeyounow”to“the
patientwillseethedoctornow.”6
Patientsneedengage-
ment beyond passively receiving services, but this will
be challenging until they can easily access and use their
health data. For this to proceed, control of health data
must be transferred to the patient or the patient’s au-
thorized representative.
Morespecifically,toobtainactivepatientengagement
andhealthsystemimprovement,3componentsarenec-
essary: (1) common data elements that enable the shar-
ing and merging of health data from multiple sources;
(2)apatientencounterdatareceipt,comprisedofrelevant
health data from each health care encounter, automati-
callypushedtothepatient’scompletedigitalhealthrec-
ord;and(3)acontractbetweenpatientsandthird-party
healthdatamanagers(eg,healthcareorganizationsand
commercial entities) that enables individuals to control
theirlongitudinaldigitalhealthrecord.Mostofthesecom-
ponentsalreadyexistinsomeform,requiringonlyminor
adjustments to effect health system transformation.
Clinicians, patients, and health care systems need
awaytoefficientlyreceive,integrate,understand,com-
pute, and use digital health data from other practition-
ers and health encounter locations. This requires the
merging of what is often disparate data from multiple
sources, and the most effective way to do this is to es-
tablish common data elements agnostic of any particu-
lar vendor’s electronic health record (EHR) system.
Withwidespreadimplementationofcommondata
elements and value sets, semantic and clinical interop-
erabilitycanbeachieved,andhealthinformationcanbe
merged, while maintaining data integrity. New initia-
tives, such as the Standard Health Record,7
that focus
on standardizing data within health rec-
ords instead of solely on exchange stan-
dards enable the development of one
complete, digital health record per pa-
tientcontaininghealthdatamergedfrom
allofapatient’scliniciansandrelatedhealthdatasources.
For example, applying common data elements to plat-
formscanenablepatientstoaddpatient-generateddata
into the record in addition to clinician-generated data.
Withitscommon,unifyingtemplate,theStandardHealth
Record can also support a host of secondary uses, such
aspatient-centeredoutcomeresearch,precisionmedi-
cine,andprecisionpublichealthsurveillance.Thiscom-
mon digital health data language is also anticipated to
reduce translation and comprehension errors.
Common data elements have legislative and regula-
torysupport.Forexample,oneMeaningfulUseobjective
is to provide patients with the ability to view, download,
ortransmitcertainhealthinformation,includingvitalsigns
andlaboratorytestresults.Section4003ofthe21stCen-
turyCuresActalsorequirestheDepartmentofHealthand
Human Services to evaluate the need for a “core set of
commondataelementsandassociatedvaluesets”toen-
hance the exchange of structured health information.
Patients need and deserve the
opportunity to control their health data.
VIEWPOINT
Katherine A. Mikk, JD
Open Health Services,
The MITRE
Corporation, Bedford,
Massachusetts.
Harry A. Sleeper
Open Health Services,
The MITRE
Corporation, Bedford,
Massachusetts.
Eric J. Topol, MD
Scripps Translational
Science Institute,
La Jolla, California.
Corresponding
Author: Katherine A.
Mikk, JD, MITRE Corp,
202 Burlington Rd,
Bedford, MA 01730
(kmikk@mitre.org).
jama.com (Reprinted) JAMA Published online September 25, 2017 E1
3 components are necessary:
(1) common data elements that enable
the sharing and merging of health data from
multiple sources;
(2) a patient encounter data receipt,
comprised of relevant health data from each
health care encounter, automatically pushed to
the patient’s complete digital health record; and
(3) a contract between patients and third-
party health data managers (eg, health care
organizations and commercial entities) that
enables individuals to control their
longitudinal digital health record.
George Neyarapally,
PharmD, MPH, JD
Open Health Services,
The MITRE Corporation,
Bedford, Massachusetts

47. Data Completeness

48. Data Completeness Continuum

49. another side note…

50. Drawing pictures
helps comprehension.
…no kidding.

51. Yet, academics, scientists,
& executives need
evidence (like this paper)
to get graphic storytelling
included as part of
products.

54. back to owning your data…

55. When you own your data,
you control access.
3.

57. Let’s start
An open source project by MITRE. Email us.

61. Owning your data gives you
health autonomy.
4.

62. Ownership rights are the right to:
Possess
Share
Sell
Destroy

63. Patients co-own or fully own every health data point about themselves.
Health data generated about the patient by a provider is co-owned by
both parties.
Health data generated by the patient is fully owned by the patient with
a right to possess, share, sell, or destroy.
All uses of a patients’ health data shall be consented in advance by the
patient, other than uses required by law.
Patient Data Ownership

64. Th
e health-care systems will co-own a private Seattle-
based startup company called Truveta that will aggregate
the data and make it available to researchers health-care
providers and pharmaceutical companies CEO Terry
Myerson said.
Although health-care providers have shared data before
sometimes for speci
fi
c conditions like COVID-19 “this is
unprecedented in terms of its scale” Myerson said.
Together the 14 systems have facilities in 40 states and
are in communities with more than 100 million people
according to Truveta.
Do patients opt-out?

65. Together, those two systems represent nearly 40% of patients in the
Puget Sound region, according to Truveta.
More data sharing during the coronavirus pandemic could have
provided faster information about how patients were responding to
certain treatments or how many patients were experiencing
symptoms like the loss of taste and smell, Myerson said.
Th
e health-care systems are
fi
nancing the company, with each
owning an equal share, Myerson said. He declined to say how much
funding the company has received.
Eventually, the company will sell access to the data. Pharmaceutical
companies designing clinical trials or looking for information about
side e
ff
ects of medications would pay to access the data, Myerson
said. For others, like student researchers, “we would want to
fi
nd a
way to make that happen,” he said.

66. Modern Healthcare reports (here) that Ascension is expanding its EHR record searching experiments with Google, notwithstanding
controversy which accompanied the original announcement. Fourteen major health systems are creating Truveta (STAT+ report here):
“
Th
e health systems that formed and invested in the for-pro
fi
t venture span 40 states and hold data on about 13% of the care delivered in
the United States . . . they are seeking to create a business that would function
something like a public utility, parceling out data needed to create new
devices and treatments for everything from Covid-19 to cancer. But the
concept the company rests upon — that patient data is a commodity that
can be bought and sold, like coal or co
ff
ee — is one that sits uneasily in
American health care, where many stakeholders de
fi
ne that information
as something owned by the individual, who has an inherent right to
direct its use. Indeed, a loss of control over such data is seen as
dangerous, potentially leading to a loss of privacy, discrimination, and a
slew of other problems.”
Th
e Wall Street Journal reports on the venture, here.
Say “Yes” to Monetizing Patient Data

67. Additional considerations for patient data ownership:
Create a new category of IP law
…where property could be time-limited like copyright,
allowing data to become publicly available after some time
Public ownership of anonymized data in aggregated
databases
3rd party that aggregates and holds patient medical data,
provides access to the data at the direction of patient

68. www.whereismymedicalrecord.org

69. Good!
Access to all of your record, including your clinical notes
Reporting instructions on blocking, errors++
Needs:
Data ownership (right to sell; and restricting others’ right to
share/sell my heath data)
A standard PHR to drive standardized assessments, analysis, self
care, and improved clinical care

70. Th
e Rule ensures that entities
not covered by the Health
Insurance Portability and
Accountability Act (HIPAA)
face accountability when
consumers’ sensitive health
information is breached…
… Companies that fail to
comply with the rule could be
subject to monetary penalties of
up to $43,792 per violation per
day.

71. Page 12, MITRE’s 2021 National Strategy for Digital Health
https://www.mitre.org/publications/technical-papers/a-national-strategy-for-digital-health
“Truly empowering the individual
in the future would entail
extending beyond access to
changes needed for individuals to
have more control of their
information.”

72. Own Data? Ethical Re
fl
ections on Data Ownership
13.Sep.09
https://www.researchgate.net/publication/342188494_Own_Data_Ethical_Re
fl
ections_on_Data_Ownership
Data as Property
16.Oct.20
https://phenomenalworld.org/analysis/data-as-property
Mine! How the Hidden Rules of Ownership Control our Lives
3.Mar.21
https://scholarship.law.columbia.edu/books/296/
Why Companies Should Give Consumers Ownership Of
Th
eir Health Data
1.Apr.22
https://www.forbes.com/sites/forbesbusinesscouncil/2022/04/01/why-companies-should-give-consumers-
ownership-of-their-health-data/amp/

73. “Users own their own data, identity, content,
and algorithms, and can govern the blockchain
protocols they use by owning governance
tokens,”
“Users participate as ‘shareholders’ by owning
the protocols’ tokens or cryptocurrencies.”
= own your data,
own your AI model

74. Any healthcare system that doesn’t give you
this data is mistreating you.

75. Th
e last frontier for capitalism to sell:
the human mind.

76. Surveillance Capitalists’ Mantra
“Let's see what we can
exploit, extract, get away with...
… these fu#ker$ won't know what hit them.”

77. We demand patient data ownership rights.

78. data use agreement . org

79. Publicly-accessible code
Licensed under an open source agreement
Apache 2.0 = generous license for commercial, private use
Community actions, decisions, critiques

80. Why is the
Data Use Agreement,
Patient Data Manager,
Patient Data Receipt, and
Patient Health Record,
open source?

81. You can’t solve healthcare until
you ask the people to participate.
5.

82. I will share my medical knowledge
for the bene
fi
t of the patient and the
advancement of healthcare
Declaration of Geneva,1948
Our black box algorithm risk-adjusts
and care plans for half of US residents.
Pharmacy Bene
fi
t Manager,2022

84. When you use a HC service,
you don’t know…
how it works,
why it works,
who it works best for, and
if the results are true.

85. If healthcare is so noble,
if it’s key to our life on earth,
if we don’t have choice…
…we demand healthcare to be open.

86. Th
e Internet is
… open source
… a human right.
infrastructure

87. Application
Presentation
Session
Transport
Network
Data
Physical
Human-computer interaction layer, where
apps can access the network services
Ensures that data is in a usable format, where
data encryption can occur
Maintains connections, responsible for
controlling ports + sessions
Transmits data using transmission protocols
(TCP, UDP)
Decides which physical path the data will take
De
fi
nes the format of data on the network
Transmits raw bit stream over a physical medium
open source
OSI MODEL

88. Open Gov
Android
Apache
Linux
MySQL
Arduino
Wikipedia
PLOS W3C

89. Health Data Manager
should be
open source
most healthIT
is closed
“We have
anti-open source.”
Eric Topol, MD

90. “Epic EHR should be open source.”
Elizabeth Nabel, President of Brigham Health, 2017
“Open source is fundamental.
Th
e fact that we don’t have open healthcare
re
fl
ects the deepness of our problem.”
Eric Topol, Scripps Research, 2018

92. FHIR
Open Humans SageBionetworks
Standard Health Record
openEMR
HealthKit
Synthea
CodeX

93. Infrastructure,
Common Good Services
Leading Edge,
Speculative Research
Open Source Healthcare
suited for…
Global Emergency

96. Linux Foundation Public Health
www.lfph.io

97. Home Care Basics.org
All of the GoInvo projects are open source, on GitHub,
licensed under Creative Commons Attribution v4 or Apache v2 license.
Understanding Coronavirus.org
hGraph.org

98. C19HCC.org

99. Pretty amazing response.
We’re not done.

101. What’s your agenda?

102. focus longer play
aka fantasy

103. What’s the
system
engineering?

104. https://www.nytimes.com/2021/01/08/opinion/georgia-black-political-power.html
Who’s our Stacey Abrams for M4A?

105. We have to be deliberate in
committing to open source.

106. Care Cards.me
Determinants of Health.org
hGraph.org
Inspired EHRs.org
Arlington Visual Budget.us
List of Demands.us
Open Source Timeline.com
Health Picture
UnderstandingCoronavirus.org
Linux Foundation Public Health
US Healthcare Problems.com
} Studio investment
~$2.5MM over 8yrs
} Client investment
~$3.5MM over 5yrs
~$275k in 2022
~$310k in 2021
Standard Health Record.org
Flux Notes.org
Health Data Basics.org
PDM, PHR, pDUA, PHReceipt
Open US Health Dashboard
Personal Genome Project
Open Humans
Mount Sinai eConsent
Walgreens
openAutism
Common Health
NIH/All of Us

107. 2023 Open Source Healthcare Agenda for GoInvo
Own Your Health Data Act goinvo.com/about/

108. Patient Data Ownership for Massachusetts
Campaign for the public, elected o
ffi
cials,
and clinical administrators
Easy-to-Chew-on-Stories… in digital and analog
Own Your Health Data Act for Massachusetts

109. Own Your Health Data Act for Massachusetts

110. ownyourhealthdata.org
live project, on github
roping in local MA reps
ownyourhealthdata.com

111. Healthcare and public health
are a utility,
a human right, and
too important to be closed.

112. Having your health data can save your life.
6.
You can’t solve healthcare until you ask the people to participate.
5.
Owning your data gives you health autonomy.
4.
When you own your data, you control access.
3.
Health data includes more than you think.
1.
Recap
You don’t own your health data. And you should.
2.

113. Special thanks to:
Eric Benoit,
Jen Patel Sobus,
Sharon Lee,
Jon Follett,
Daniel Reeves,
Craig McGinley,
Parsuree Vatanasirisuk,
Shayla Netty,
Chloe Ma,
Claire Lin,
Tala Habbab,
Kim Nipp,
Annie Becker,
Hannah Sennik,
Colleen Tang Poy,
Patricia Nguyen,
Bryson Wong,
Edwin Choi,
Sarah Kaiser
Harry Sleeper,
Kathy Mikk,
George Neyarapally,
Andre Quina,
Salim Semy,
Jason Walonoski,
Mark Kramer,
Eric Topol,
John Wilbanks,
Jane Sarasohn-Kahn

114. Open Source Healthcare.org
juhan@mit.edu