Don E. Detmer, MD, MAPresident and CEO, American Medical Informatics Association

Bethesda, MarylandProfessor of Medical Education, University of Virginia

Charlottesville, Virginia

An International Overview of EHR Initiatives

NHIIs of English speaking nationsPersonal Health Records

Standards for NHIIs & System TransformationStatus of Terminologies & Classification

Clinical Trial Registrations & Banks

An International Overview of EHR (& Related) Initiatives

•NHIIs & PHRs:– Current status & aspirations

• Best practice lessons• Take home messages* Detmer DE, Steen EB: Learning from Abroad: Lessons and Questions on Personal Health Records for National Policy. AARP Policy Report #2006-10, March 2006. see http://www.aarp.org/research/health/healthliteracy/2006_10_phr_abroad.html

International NHIIs & PHRs*Australia, Canada, England & New Zealand

• Review of government materials/websites & related published & other available literature

• Structured interview of 11 acknowledged national &/or international experts- Telephone (9) & e-mail (2)

• At least 2 each for Australia, Canada, United Kingdom, & New Zealand plus experts in Sweden

Study Methods (1)

• Face validity check of preliminary findings with 3reviews & comments from AARP experts

• Conclusions & Recommendations for USA

–Solely by DED & EBS

Study Methods (2)

Aging populationsNew technology & treatmentsRising public expectationsAwareness of health system deficienciesPatient demand for greater choice & involvement in decision makingHealth IT underdeveloped in terms of national goals for potential positive impact

Challenges Shared by all FiveHealth Care Systems

Equal access to health servicesRaising qualityImproving health outcomesAchieving sustainable financingImproving efficiencyFostering greater responsivenessCitizen involvement in decision making

System Objectives of all fourHealth Care Systems studied

Patient safety must be assured, & quality of services must be improved.Population health, primary care, & chronic disease management capabilities are pivotal.A robust information infrastructure that enables connectivity among providers is essential.The health system & electronic patient records must be patient-centered & support patient empowerment while maintaining patient privacy.

Guiding Principles of all FourHealth Care Systems

• Strong emphasis on standards to enable connectivity & interoperability.

• Privacy is a priority & is recognized as a greater challenge in those countries where both federal (national) & state/ provincial laws must be aligned. In each of the four countries, a privacy commissioner provides a visible focal point for the development of privacy policy & the enforcement of privacy laws.

• Unique personal health identifiers are planned or are in use at the national level in three of the countries & at the province level in Canada.

• The public is increasingly using the Internet & does so for health purposes much of the time.

Similarities in the HIT Environments of the four nations

Australia: HealthConnectState by state EHR network

Canada: Health InfowaypanCanadian EHR framework built on provincial system

England: Connecting for HealthNew Zealand: Recently revised IT strategy for health

National Approaches to NHII & EHRs

Key Driver: Electronic Medical Record System for Clinical Operations

Key Driver: Population / Public Health Records for Management

PHRs: England’s HealthSpace, etc.; less integrated than NCVHS model

Architecture of NHIIs of Australia, Canada, England & New Zealand

Aspiration for PHRs going forward: Integrate for Chronic Care Purposes

PATIENT Records –Clinic & Hospital

Records

PERSONALRecords –

Consumer & e-health records

PUBLIC HEALTH/POPULATION

Records –Community Records

Data Banks Repositories

Interlocking Computer-based Health Records (C3PRs)supported by knowledge (Research & Development / Education & Training with IT infrastructure)

First-classHealth Care

InfostructureKnowledge & Delivery

# 3

#1# 2

#4/5 Research &Development

# 4/5Education

&

Training

“An electronic application through which individuals can maintain & manage their health information, & that of others for whom they are authorized, in a private, secure, & confidential environment that allows the individual or other authorized persons to access and share such information.”

ASTM International ePHR Definition E2211-02 Standard

“ If you’ve seen one PHR; you’ve seen one PHR.* ”

Types:

• Paper-based• Computer-based• Computer-based but not linked with care ,

e.g., separately maintained• Fully integrated with clinician’s record

* e-PHRs: A bit like a unicorn: Everyone knows about them but nobody has seen one.

• The Patient has access to: – Appointments – Problem List – Medications – Allergies – Subset of test results – Demographic & Insurance information– Educational materials

• The patient access is via secure internet with their permission. • Patients can request appointments, get meds mailed to them,

securely message their physician, etc. •The Physician sees virtually all information; Some

departments such as addiction medicine is hidden.

Homer Chin, MD, KP

eiPHR (Integrated EMR/PHR) “The Gold Standard”

eiPHR“…beyond satisfaction & into trust.”

Source: Charles Safran

• Limited use of PHRs & ePHRs today.• England’s National Health Service (NHS) offers HealthSpace, a patient-initiated health organizer. • England & Australia plan patient access to part of clinical care records in the future (by 2008 in England), but with limited functionality.• ePHR activity limited to small-scale evaluations• Less private sector focus on ePHRs than in US• No explicit plans for eiPHRs

Findings on ePHRs

Best Practices1. UK implementing ePHR for all citizens within national framework

for EHRs (HealthSpace) - Personal online health organizer

2. Australia & UK provide good examples of consumer engagements

• Australia Consumer Health Forum

• NHS Connecting for Health

3. Canada - significant national public investment; implementation focused on regional needs & status

4. All countries studied ahead of US with regard to privacy framework

5. The European Union e-Citizen program provides a model for improving computer skills among potential ePHR users.

• National patient identifier• Public education needed

– ( see EU e-Citizen program)

• Chronic illness over generally healthy individuals• Payment an issue in non-national health care systems

Other Best Practices:Take Home Messages from Sweden’s SUSTAIN system

PHRs: England, Australia, New Zealand, Canada

National Financing: England, Canada, Australia, New Zealand

Unique Health Identifiers: All

Decision Support Systems: Australia, England, Canada, New Zealand

Educational Strategy:All

NHII Scorecard?

USA OnlyePHRs are a ‘hot topic’Equity of access is not a key

healthcare policyIndividual control/autonomy

emphasized over educationNo policy for personal

authenticationMostly rhetoric & meager Federal $

investment

Conclusions (1) : Consumers/Citizens &National Health Policy Emphasis

Nations Studied

ePHRs not a ‘hot topic’

Policy assures equity of access to care

Education emphasized over patient control

Personal Unique Health ID / National IT Card

Strongest concern is for confidentiality & security over privacy

Action & Substantial $ / £ s

USA – EPRs as ‘hot topic.’

Individual Autonomy & Personal Control; Health through research

Individual Autonomy & Control* ≈ Mistrust & Suspicion

Policy Outcome: Privacy Policy becomes endless debate with health & privacy in conflict

Conclusions (1) : Ascendant Principles for Government’s Role

’Hans, this surgery is a serious business.’- Hans Brinker & the Silver Skates.

Nations Studied - Education as ‘hot topic’.

Social solidarity; Health through services

Social Solidarity ≈ Trust

Policy Outcome: Privacy Policy moves on to dealing with confidentiality, security, & sanctions for breaches

Onora O’Neill: Autonomy and Trust in Biomedical Ethics Cambridge University Press 2001

Is there an optimal approach to introducing ePHRs to large populations? What levels and kinds of resources are needed to support large ePHR

implementations, particularly user support? How do various patient populations (e.g., different ages, healthy versus chronic

versus terminal patients) use ePHRs? Can we quantify the costs and benefits of ePHR systems for individual citizens,

health organizations, & the health system? These evaluations should include costs to consumers (computers, Internet service), costs to the ePHR manager (data management & transfer), & providers’ costs of interacting with PHRs. The evaluations should seek to measure the benefits to consumers, health providers, & third-party payers.

Can ePHR modules designed abroad to support chronic disease management be adapted for use in the United States? Can ePHR modules developed in the United States be shared among organizations?

Questions for ePHR/NHII Research Agenda

• Considerations– Collaborate with WHO &

others to set standards– Unclear today how successful

WHO can/will be with leadership

Be a player in global terminology & classification systems.

A Global Trial Bank for Clinical Trial Information

The present system of publishing trials is broken

WHO is favoring multiple nations registering trials with WHO as policy

setting agency

Also clinicaltrials.gov at US National Library of Medicine

for serious & life-threatening disease(Canada & Germany interested in

working with NLM)

Pharma industry seeking to post its own results

Editors who publish trials are seeking to assure a better approach by

urging submission of protocol at time of review

A better system• Systematic review of what’s known & what questions

need answering• Protocol on the web• Full posting on the web of all data• Results immediately incorporated into systematic review,

allowing possible identification of fraudulent studies• Everything open, anybody can comment at any time• Role of journals is to to comment, digest, discuss—not

publish the trials

Trial Bank Definition

A computable repository of clinical trial information sufficiently detailed to support evidence-based decisions, practice & policy making (e.g., systematic reviews)

• Study Design• Study Execution• Summary &/or Individual Participant-

level Results

Why do we need Global Trial Bank?• People risk own health contributing to health-

related knowledge & they deserve results • To avoid bias and distorted reporting of results• Prose is not computer readable• To effectively manage the highly valuable

knowledge that is contained in clinical trials• To make results available to everybody

everywhere for free

…

What will be the benefits of GTB?

• Easy access for trial participants, patients, & the public with a patient-friendly search engine

• Easy access for clinicians plus decision support systems to match trial results to patients

• For researchers: easier to retrieve trials, evaluate their quality, assess their scientific value, & combine evidence

• Funders can avoid duplication of trials• Will help informaticians develop methods for mining & displaying

data & using trial data in clinical decision support systems

How is GTB different from trial registers?

• Enough data for full evaluation of scientific worth

• Peer reviewed• Contents are computable

What content will be included?• All trials• Protocol information: 20 item minimum data set coded

using SNOMED-CT: interventions, key conditions for eligibility, primary & secondary outcomes, harms, full e-document of protocol

• Results—all information in ICH E3 summary: baseline characteristics; intention to treat summary level results for all outcomes in all intervention & a priori subgroups at specified time-points; compliance data, results for per protocol analysis

Do we have any evidence on the practicality & usefulness of

Global Trial Bank?

Ida Sim, MD, PhD, Ben Olasov MS

Associate Professor of MedicineUniversity of California, San Francisco, CA, USA

Trial Bank Publishing of Randomized Controlled Trials:

Preliminary Results

Conclusions from research

• Trials can be presented in RCT presenter starting from journal articles

• It doesn’t take long, especially for those familiar with RCT Presenter (probably less than writing a paper)

• Experts find it easier to assess trials from RCT presenter than from journal articles

RCT Presenter Demo

• RCT Presenter is open access– http://rctbank.ucsf.edu/Presenter/

The State of the GTB Project

• Being run by the American Medical Informatics Association (not for profit, 3500 plus members, multiple disciplines, members in 42 nations)

• Support of IMIA & EU’s HealthGrid• Seed money developing business plan • Up and running—2007?

Don E. Detmer, MD, MA 301 657-1291 detmer@amia.org

References

1. Detmer DE. Building the National Health Information Infrastructure for Personal Health, Health Care Services, Public Health, and Research. BMC Med Inform Decis Mak. 2003; 3:1-40.

2. Berner ES, Detmer DE, Simborg D: Will the Wave Finally Break? A Brief View of the Adoption of Electronic Medical Records in the United States. J Am Med Inform Assoc. 2005 January-February;12(1):3-7. Epub 2004 Oct 18.

3. Pagliari C, Sloan D, Gregor P, Sullivan F, Detmer DE, Kahan JP, Oortwin W, McGillivray S: What is eHealth (4): A Scoping Exercise to Map the Field. JMIR 2005 (Mar31); 7(1):e9. see http://www.jmir.org/2005/1/e9/

4. Detmer DE, Singleton P. Policy for Informed Patients: A European Perspective. Harvard Health Policy Review Harvard Health Policy Review 2004 Spring;5(1)81-88.

5. Kalra P, Singleton P, Ingram D, Milan J, MacKay J, Detmer D, Rector A: Security and Confidentiality Approach for the Clinical E-Science Framework (CLEF) Methods Inf Med 2005; 44: 193-7.

6. Melzer D, Detmer D, and Zimmern R: Pharmacogenetics and Public Policy: Expert Views in Europe and North America. Pharmacogenomics 2003; 4:689-91

7. Sim I, Detmer DE: Beyond Trial Registration: A Global Trial Bank for Clinical Trial Reporting. PLoSMedicine 2005;2 (11):e365

8. Detmer DE, Steen EB: Learning from Abroad: Lessons and Questions on Personal Health Records for National Policy. AARP Policy Report #2006-10, March 2006. see http://www.aarp.org/research/health/healthliteracy/2006_10_phr_abroad.html

Thank you & best wishes

AMIA Initiatives

American Medical Informatics Association

http://www.amia.org

Annual Symposium• Strong tutorial program

– Primer series– EHR series– Methods series– Selected topics series

• Late breaking policy sessions

David Bates, MD, Program Chair