VA short Welcome! 

Clinical Databases and Digital 

Health Technology to Build a 

Learning Health System 

and Patient Centered Care 

 

2/10/2014 1 

John Øvretveit,

 Director of Research, Professor of Health Innovation and 

Evaluation, Karolinska Institutet, Stockholm, Sweden
Subject • Clinical Databases 

– Patients data in a data bank 

• Digital Health Technology 

– Software to collect analyse and send the data

– Visual displays for easy understanding

–Devices – body monitors and mobile

• ...to Build a Learning Health System 

– learn about patients – what causes ill health, what 

improved servcies, research

• and Patient Centered Care

–Using the patient data in consultations 2
Subject

• Patient register 

–data bank storing your clinical data and 

others

• Uses 

• Issues

• Questions to you about your registers 

and systems

• If time: learning health system 3
Questions: 1 = Yes; 2 = No; 3 = Other

• I have entered-in data about my health on a 

web site

• I know who has access to this data

• The web site told me who has acces

• The web site asked my permission to give my 

data to specified other

• I know who has access to data my physician 

records about me 

• This is different for veterans (Kaiser?) 4
John’s CVS ‘flue jab

• Cannot show scan of agreement

• We are covered by strict HIPAA 

regulations about who has access.

• Those with access can do what they like 

with your data – we have no control over 

them 5
Issues

• Control and privacy one issue in using 

patient registries 

–Changing attitudes and laws 

• 2011 google health, 2012 facebook, 2013 NSA

• Affects our research 

• May slow or speed developments in 

health care

6
Agenda 

• Patient registries 

–explanation in English

• Examples of uses 

–Enabled services, real time low cost 

research, service improvement 

• Future creation and use of patiet

registries 7
The problem – digital reflects real 

world fragmentation in care • Each physician own business with own 

EMR 

–most do not connect with others (2014)

• Can’t see others treatments and 

assessment

= We have to repeat our story, optimal 

care less likely

Problem 1: Unconnected 8
Problems – underuse of patient clinical 

data 

• EMR under-developed for intelligent 

support 

–reminders and alerts, effective treatments 

for patients like me, best practice guidance

–Systems not scanning EMRs for best 

practice and risks

• Body monitors and our assessments not 

contributing data to care or research 9
NEXT - Basic idea 

– for 12 year olds

10
Connecting 

Systems

Understanding clinical data flows and storage 

 

My clinical data

I get my data 

and reminders 

or alerts

Any provider 

authorised , at 

any time, all 

needed data 

at point of 

care

My personal body 

monitoring

 - automatically sends

T 

A register data 

bank (RegDB) 

I input data 

(eg patient 

reported 

outcomes)

Physician 

inputs my 

clinical data

(EMR) 

Health care provider 

A bit like my 

face-book 

web page?
Patient Registers - Types 

• All patients with one disease or 

treatment (“Focused register”)

–In nation, region, health system, one 

physicians patients

• All patients, all clinical data 

(comprehensive patient register)

12
Explanation 

• EMR “feeds” register, & receives register services 

• Physician / patient access register in consultation

= “Smart registers” give alternative to EMR

–Give “service add ons” 

• “smart register services” deliver patient data or 

analyses over time – shows time trends 

– Physician or patient can request real time analysis

• http://www.srq.n.nu/, research

13
Example of real time analysis (“smart 

register” services)

Chart shows user can ask eg show a) cost of 

medications, b) patient reported outcomes.

Physician or patient can request real time analysis

• http://www.srq.n.nu/, research

14
Example 1: Swedish Hip Registry

• 35 yrs old

Data: 

• Patient demographics

• Procedure/treatment

• Clinical outcomes

• PROs

(cannot show web site or examples) 15
How the register improved outcomes 

• Reduced reoperation rate 10times

• Converge on 6 miin protheses

• Two standard operations

• Happened voluntarily 

just by yearly reports 

and presentation at annual conference

Allowed considerable other research

Future – relate to patient genome profiles 16
Significance - Savings

US $24 bln costs for replacement/repair 

Could avoid $2 bln

Other registers – Treatments, and disease 

based

• Eg Diabetes Register 95% all departments of 

medicine 75% of all PHCs

100 17
The other swedish registries

BCG estimate 10yr 1: 10 ROI

Sweden increased funding 5 fold

• Biggest improvements from public data 

• Both poor & high performers show 

significant improvements.

• Success = quality data; transparency; and 

physician involvement

18
One contributor to Q/cost performance

• Cannot show graph – shows sweden highest 

on OECD quality index – middle of range on 

9% GNP 

19
Swedish international comparisons initiative 

• You can see this on Stefan Larsson: What doctors can 

learn from each other

http://itunes.com/apps/tedconferences/ted

20
ICHOM Initiative 

Consortium of Health Outcomes 

Measurement ICHOM

•

•

•

http://www.ichom.org/project/low-backpain/ 

http://www.ichom.org/medical-conditions/

http://www.ichom.org/ 

21
Points from example 1

• For you what is significant from this?

–Could it work here?

• Patient reported outcome

• Patient confidence 

• Patient benefit

• Time for data to influence practice

• Did not need financial incentives

• Relevance to other treatments/diseases22
p 

Swedish Rheumatiod 

Arthritis Registry and co-care 

learning health system •

. 

23
2) Arthritis co-care supported by clinical data 

system

Patient enters data (cannot show picture of 

tablet)

http://www.srq.n.nu/films 

•

•

http://healthstories.se/?p=13 1.51

http://www.srq.n.nu/films 1.51

• 1.51

• /films 1.51

2

4

2/10/2014
• Then: Clinical data base . presents trends in 

treatment and patient-reported disease score

Cannot show visual display 

•

•

http://healthstories.se/?p=13 1.51

http://www.srq.n.nu/films 1.51

2

5

2/10/2014
Patient Provider

DHT clinical

data base

Other patients

Performance comparisons

Research (genome data base) 
Questions KI/DTI/RWJ study 

• Will empowerment of arthritis registry work with 

others? 

Challenges adopting model in USA 

• EMR proprietary – abstract data from EMR for 

registry?

• Exchange upload data

• Physician uptake

• De indentified patient data in separate system – 

no owneship issues?

• http://217.76.63.11:8080/rareg/ 27
Points from example 2

• For you, what is significant from this?

–Could it work here?

Register enabled services direct to patient 

and physician

–At point of care

• Enables but does not ensure SDM/co-care

•Physicians need training for SDM

• Service direct to patient at home 28
Points from example 2

• Visual presentation under-developed 

• Can less-literate patients benfit? 

Use for other patient 

diseases/groups? 

Platform for connecting users

29
Example 3: 

C3N 

•. 

30
Example 3: Cicinatti C3N model 

• IBD Register is part of national network

http://c3nproject.org/ 

• C3N = internet platform for patients, providers and researchers to 

work together to improve care

Network-based production for health? 

• 1. Focus on outcome 

• 2. Build community 

• 3. Effective use of technology 

• 4. Learning system – System science, QI, qualitative research, 

clinical research 

 31
Learning health systems: network platform

• EMR individual patient data

• Patient-entered data

• Monitoring “Always on Software”

• Linked data bases with patient identifier

• Patient groups contributing 

32
Patients like me – to July 2012

 PatientsLikeMe members have shared...

 4,029,661 symptom reports about 7,338 symptoms

 548,650 treatment histories about 12,838 treatments 

 Data reflected back to you to learn from, 

“Long tail Research”

 Over 5 years published 27 studies, & shared aggregated data 

with eg researchers behind ALS Untangled. 

3

3
Patients contributing to comparative 

effectiveness research

PCORnet 

18 Patient-Powered Research Networks (PPRNs) run 

&governed by groups of patients and their partners 

particular condition 

interested in sharing health information and 

participating in research; 

3

4
Points from example 3

• Register-related “platform”

• For you what is significant from this?

–Could it work here?

• Register part of Web site “Forum” for 

partnerships 

• Enables but does not ensure partnerships

–More likely because of close community and 

values

–Use for other patient diseases/groups? 35
Questions Yes No Other

• I can name a patient register I know of

• I have some idea where it gets the data 

from 

• I have used register data in my research

• I know the rules about research access 

and use

• I need to know more about this in the 

future 36
HIPAA

Get written authorization from subjects before 

their personal health information can be used

• Or demonstrate that research meets 

requirements that exempt written 

authorization, 

• such as the use of information that is not 

individually identifiable (eg the birth date or 

social security number must be removed). 

• Get consent using on-line tool -later 37
Future

•. 

38
Future creation and use of patient 

register & register enabled 

services

• Privacy control, access, security

• Inequities of health – increase or 

decrease

• Software robots

• Research

• Improvement & learning health system39
Example : patient access to heart data

• Implanted defribillator

• beats too fast or slow,

zaps back to normal. 

• Constant data collection

“ relayed through the 

physician to ensure proper 

interpretation and 

explanation” FDA 40
Example : patient access to heart data

• At checkup found 

defective – surgery

“. "If I had been able to follow my 

own reports, I would not have 

walked around for an entire year 

with a potentially dangerous 

problem,”

Different with apps - iPhone and 

sleep-monitoring app - "There is 

no real law that protects that 

data." 41
Privacy 

• 20 focus groups 

•should have control over 

whether and how “their” data 

are shared and used (Schneider 

2009) 

• 75% OK for research if consent 

asked 

42
Privacy 

•IOM recent 

•should have control over 

whether and how “their” data 

are shared and used (Schneider 

2009)

• 75% OK for research if consent 

asked 43
Your newborn

• Blod spot specimin 

• Blood stored by state departments of 

health 

• Case against Texas DoH for not 

seeking consent led to 5m destroyed.

• Initiative to seek consent

44
“Private Access” – set preferences

• Private Access, https://www.privateaccess.info. 

45
Inequalities?

• Data allows research to identify

–Inequalities in health

–differential risks of different patient 

subgroups 

• Long term decrease?

• Short-term increase?: use of data and 

services by low literacy patients and low 

income physicians 46
Interventions to enable patient to 

make more use 

• Talking Touchscreen has Health LiTT

• http://www.healthlitt.org 

• measure of health literacy 

–Can be self-administered (Eng or Spanish) 

uses sound, text, and images. 

–Cover health- and insurance-related topics 

and informed consent. 47
Summary

• Digital data and systems will transform 

healthcare 

–Patient self-care, provider support, 

feedback about outcomes of service 

changes, real time research.

• Benefits slowed 

–by uptake assistance and delays in updating 

regulations and reimbursement 

• Urgent research: privacy, inequites 48
Questions to you

• We use this register..

• Patients consent or what told

• Rules for access by research and 

others

• 5 years – what different?

To follow – learning health system49
Learning health 

system concept

•. 

50
Feautres of LHS

• Data from EMR and registries

• Real-time research – Breaks down boundaries

• Networks for co-care, co-research, codesign

51
One definition focuses on patient-researcher partnerships as key feature

• 94 % of U.S. adult social media users with health 

conditions strongly endorse sharing their health data 

anonymously to help improve health care.

• 76 percent of American social media users with a 

medical condition believe that data from their personal 

health record potentially could be used without their 

knowledge. 

•

52
Significance - Learning health system

53
Significance of LHS

• Check impact of changes on patient outcomes and 

costs

• Health system use EMR data and other data in 

different ways:

– Check for indicators of adverse events (safe-care 

Kaiser) 

–Natural linguistic programming and structure records 

– Software trawl data for patterns

– Real time research and comparisons 

54
LHS - issues

Privacy

Physicians protective 

Connecting systems

Physician practice change to enable patient 

participation

Costs 

Unskilled design and implementation

Safety 

Increases disparities? – less educated patients 55
LHS - issues

For us as patient

Faster benefits

Is our data being used for purposes we may not 

like? 

Who owns clinical data streamed from monitors?

Heart Gadgets Test Privacy-Law Limits

• http://online.wsj.com/news/articles/SB1000

142405297020393700457807882087474407

6

56
The practicalities 

57
LHS - issues

Privacy

Physicians protective 

Connecting systems

Physician practice change to enable patient 

participation

Costs 

Unskilled design and implementation

Safety 

Increases disparities? – less educated patients 58
LHS - issues

For us as patient

Faster benefits

Is our data being used for purposes we may not 

like? 

Who owns clinical data streamed from monitors?

Heart Gadgets Test Privacy-Law Limits

• http://online.wsj.com/news/articles/SB1000

142405297020393700457807882087474407

6

59
Conlcusions

• How John and others benefitted from 35 

years of Hip register

• Other Swedish registries

• Expansion of funding and ROI

• Sweden international comparison initiative

• Swedish Arthritis register empowers patients

• Transfer to USA?

• Learning health system 60
Your part in making 

the future? 

61
Questions to you?

• Surprises?

• If you put in PRO, who owns the data

–Your monitoring data – who owns and has 

control of access?

• Would not work here?

• Want to know more about?

62
References • . 

• . 

63
References

• Ovretveit, J Keller, C Hvitfeldt Forsberg, H Essén, A 

Lindblad, S Brommels, M 2013 Continuous innovation: 

the development and use of the Swedish rheumatology 

register to improve the quality of arthritis care", 

International Journal for Quality in Health Care, 2013; 

Volume 25, Issue 2, doi: 10.1093/intqhc/mzt002

• Hvitfeldt, H Carli, C Nelson, Mortenson, D Ruppert, B 

Lindblad, S 2009 Feed Forward Systems for Patient 

Participation and Provider Support: Adoption Results 

From the Original US Context to Sweden and Beyond Q 

Manage Health Care Vol. 18, No. 4, pp. 247–256. 64
References 

Swedish quality registers: 

Swedish arthritis register http://www.srq.n.nu/films 

R. H. Shelton, Electronic consent channels: Preserv- ing

patient privacy without handcuffing researchers. Sci. 

Transl. Med. 3, 69cm4 (2011). 

6

5

2/10/2014
References

• C. P. Friedman, A. K. Wong, D. Blumenthal, Achieving a 

nationwide learning health system. Sci. Transl. Med. 2, 

• cm29 (2010). 

• S. Schneider, J. Kerwin, C. Robins, D. Dean, Consumer 

engagement in developing electronic health information 

systems: Final report [Prepared by Westat, Rockville, MD, under 

contract 233-02-0087, Agency for Healthcare Re- search and 

Quality (AHRQ) Publication Number 09-0081- EF, Rockville, MD, 

July 2009]. 

• http://online.wsj.com/news/articles/SB10001424052970203937

004578078820874744076

• Who owns the rights to a patient's digital footprint and who 

should control that information? WSJ's Linda Blake reports. 6

6

2/10/2014
Resources

• HIPAA Privacy Rule, http://www.hhs.gov/ocr/privacy/ 

hipaa/administrative/privacyrule/index.html. 

• Assessment Center, a free online research management tool that 

helps researchers create study-specific Web sites for securely 

capturing participant data (available at 

http://www.assessmentcenter.net

EDM forum http://www.edm-forum.org/home 

SRQ 2013 Swedish quality register web site 

http://www.srq.n.nu/, accessed 26 jan 2014. SRQ 

secretariat web site allows real time analyses by users 

through web site: http://217.76.63.11:8080/rareg/ 6

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2/10/2014
Learning health system

IOM (2007)The learning healthcare system: Workshop 

summary. Institite of Medicine Roundtable on EvidenceBased Medicine (2007), available at http://www.nap.edu/ 

catalog/11903.html. 

IOM 2014 The Learning Health System Series: Continuous 

improvement and innovation in health and health care, 

(overview of different reports in the 11 volumes of the 

IOM Learning Health System Series, published by the 

National Academies Press, Washington DC. 

Etheredge, L 2007 A Rapid-Learning Health System, Health 

Affairs ~ Web Exclusive w107-118. DOI 

10.1377/hlthaff.26.2.w107 Accessed 4th January 2014. 68
Learning health system

Academy health 2012 Using Evidence to Build a Learning 

Health Care System, Research insights, Academy health 2012 

from 

www.academyhealth.org/files/publications/AHUsingEvidence

2012.pdf, accessed 2nd Janurary 2014. 

Academy health 2012 Research insights: Using Evidence to 

Build a Learning Health Care System, Academy health 2012. 

Friedman, C Wong, A Blumenthal, D 2010 Achieving a 

nationwide learning health system. Sci. Transl. Med. 2, 

57cm29 (2010). 

J. F. Pearson, C. A. Brownstein, J. S. Brownstein, Potential for 

electronic health records and online social network- ing to 

redefine medical research. Clin. Chem. 57, 196– 204 (2011). 69
Conclusions

Each person write down and then share in the group:

1. This was new or surprising, for me...

2. The most useful idea for my work was... 

3. What I would like to find out more about...

2/10/2014 70