The Eurorec repository of Functional EHR Requirements - Gerard Freriks

EHR-Qᵀᴺ Polska 2012

The Eurorec repository of Functional
EHR Requirements

(Lodz, 29 November 2012)

Gerard Freriks
EuroRec

2012 - Gerard Freriks, EuroRec, ProRec.nl


Gerard Freriks

• Trained as General Practitioner
• Health IT since 1971
• ProRec-NL board meber
• former convener of CEN/tc251 WG1
• former EuroRec Board Member
• EN13606 Association Board Member
• ERS B.V. Director



Topics

– EHR and ISO RM/ODP Viewpoints
– EuroRec Association
– EHR Functional Requirements
• Repository
• Tooling
– Implementations
– Conclusions



MIE2012 - Village of the Future

M. Rigby/J. Hofdijk



Electronic Health Records (EHR)

All stakeholders across the EU have recognized
that the Electronic Health Record is:

-a key tool for the documentation of
the provision of safe, high quality and effective care;

-and a critical factor for clinical research.


EHR and standards
HISA
13606
Continua
...
PMAC
...

ContSys
...
SNOMED
WHO
LOINC
...

SemanticHealthNet Dipak Kalra
8
© EN13606 Association

EHR - Privacy

ACL
Trust
ACL

ACL Flexibility

ACL ACL ACL

9
© EN13606 Association


Common
Trusted
Facilities



Trust

FUNCTIONAL
Requirements

Payload
Semantic Stack

Web Services

C++, Java, ...
Windows, Linux

Hardware Platforms


Topics


• Repository
• Tooling
– Implementations
– Conclusions



EuroRec
(http://www.eurorec.org )

• The « European Institute for Health Records »
• A European not-for-profit organisation (April 16, 2003)
• Mission: the promotion of high quality Electronic Health
Record systems (EHRs) in Europe
• Federation of National ProRec Centres
(incl. all types of stakeholders)



Austria
Established ProRec Centers Belgium
Bulgaria
Denmark
France Cyprus
Italy Czech Republic
Germany Greece
Ireland Hungary
Romania Norway
Slovenia Poland
Spain
Slovakia
Serbia
The Netherlands
United Kingdom

“ Differences in languages, cultures and HC-delivery/funding systems ”



eHealth Stakeholders

Clinicians: care… (access to medical records, e-prescription, care pathways…
administrative simplifications !…)
Researchers: clinical trials, disease management studies,
post-marketing surveillance, health economics…
Health Authorities: pharmacovigilance, healthcare management,
quality assessment, utilisation review…
Data-brokers & industry: research, marketing, promotion…
Third Party Payers: billing, reimbursement…
Academics: education…
IT-vendors: software development
Regulators: legislation
Patients: their role in the future…?



Secondary use of (medical) data

Patient TRUST Clinician

PHR EHR (EMR, EPR…)

Privacy Enhancing Techniques
Clinical Trials Billing
& Research
Safety and Marketing
Adverse Knowledge
Event Decision Healthcare
Mgmt Support Management
Registers Platforms Systems



EuroRec: History of EC Projects

- MediRec (1994-95), Medical Records and Quality
- ProRec (1996-98), Promotion Strategy for EHRs in Europe
- Widenet (2000-03), Establishing EuroRec’s Network
- RIDE (2008-10), Semantic Interoperability (partner)
- EHR-Implement (2008-10), Political, Social and Economical aspects
when implementing national EHRs systems
- QREC (2006-08), Quality Labeling and Certification of EHRs in Europe
- EHR-Q-TN (2009-2011), Thematic Network
- Antilope (to start 2012- 2014)
-...



Topics


– EuroRec
EHR Functional Requirements
• Repository
• Tooling
– Implementations
– Conclusions



Rationale (Why Certification is Essential)

– Assure compliance to national rules and standards.

– Increase quality of the products through coherent and
pre-tested functionality.

– Leverage exchange of health (care) related data and
interoperability of systems.

– Improve patient safety in care.

– Have a reliable data source for secondary use.


EHRs Quality Criteria:
just a few Business Cases

• An e-Health programme wishing to implement
quality labelling or certification as to ensure
consistent EHR system functionality regionally or
nationally

• A purchaser wishing to procure an EHR system
module

• A vendor/developer wishing to document his
system or to (re-) develop an EHR system module
or wishing to interface a given module of his
system across multi-vendor systems


Benefits for the Stakeholders
Industry

Market ( R.O.I.)

EHRs - Quality Labelling / Certification

Quality and Safety Efficiency of HC Delivery Systems
Health Services Management

Patients, Clinicians
Health Authorities
Public Health



A growing number of strategic eHealth projects
are or become certification dependent, e.g.:

• Administrative simplification
• Electronic billing
• Care pathways and disease management projects
• Electronic prescription
• Interaction with validated databases
• Secure medical data exchange (summary records!)
• Interoperability, operability and portability
• ...



Certification: a powerful weapon…
New instruments

New functions
4
3

1
€

2
Pressure



How to Manage Certification?

EuroRec has Multiple Options:
1. Authority: Government (or mandated subcontr.) vs. Non Gov.

5. Self-certification by Industry (also an option!)

• National based vs. Pan European (or joint, cf. specific/generic)

• Mandatory vs. voluntary (with or without incentives)

• Formal audit/testing vs. self-assessment (or pre-test assessment)

• Scoring/rating scheme: pass/fail or more graded approach

• Scheme review rate (1,2,…n year cycles)

• Quality Assurance vs. Quality Improvement focus



“National” Certification in Europe

ure compliance to national rules and standards.
rease quality“national”products through coherent and pre-tested functiona
•Existing
of the certification
erage exchange of health (care) related data and interoperability of syst
• Foreseen within 1-2 years
prove patient safety in care.
• Considered
ve a reliable data source for secondary use.



Applicable standards
Stakeholder Applicable ISO/IEC Standard

Accreditation Body ISO/IEC 17011:2004
ISO 9000:2000
ISO/IEC 17000:2004
VIM:1993

Certification Body ISO/IEC Guide 65

Conformity Assessment Body ISO/IEC 17025:2005



Recommendations
by the EHR-QTN Consortium



Belgrade Recommendations

“ If quality labelling and certification of EHR systems is to become

generalised, then it needs

endorsement at the highest competent levels

e.g. by the EU Commission, the responsible Member States Ministries, the

Healthcare Providers Organisations and the specialised industry.”

See the Belgrade Declaration on www.eurorec.org


(summary)
1. Create and harmonise the legal and regulatory framework stimulating
national and regional authorities to enforce the use of quality labelled
and certified applications.
2. Certification bodies should be accredited and compliant to international
standards, more precisely ISO 17020.
• Strengthen the European scale pioneering initiatives (EuroRec / I.H.E.) in
order to keep certification on the agenda and invest in maintenance and
expansion of the actual descriptive statement and profiles.
• Address the issue of personnel shortage in health informatics in general
and more specifically in health informatics quality assessment.



(summary)
5. Third party assessment is the most suitable procedure for quality
labelling and certification in the still immature market of the EHR
systems.
6. The incentivised model seems the most promising, surely for self-
employed healthcare professionals.
• Promote equivalence of certificates across Europe by validating at
European level both the functional descriptive statements of EuroRec
and the IHE profiles.
• Consider the possibility to create a cross-border “Register of Quality
Labelled or Certified Clinical Software”, offering information about the
products and documentation about the certification process.



Topics

– EuroRec: EHR Functional Requirements
• Repository
• Tooling
– Implementations
– Conclusions



EuroRec’s Workflow



Typology of EHR System Statements
• Source Statements/ Referenced Statements (RS)
– faithfully extracted from existing original EHR system
specifications and test plans
– translated if necessary
• Fine Grained Statements (FGS) (at present: n>1700)
– usually derived from source statements
– made more generic, decomposed, reworded, corrected
• Good Practice Requirements (GPR) (n~150)
– recomposed from FGS into the more common useful building
blocks
– may enhance or extend the scope of FGS: “push the boat out a
bit”
• Generic Test Criteria
– derived from FGS and/or GPR
– formally worded as testable functions



Typology of Indexes
Multiple indexing of each statement to maximise the likelihood of finding
all relevant statements when searching via the indices
Business Functions (50 in 8 subcategories)
Care Settings (18 in 3 subcategories)
Component Types (18 in 4 subcategories)
•A0 EHR data (record) management •A2 Administrative services
•A00 EHR data entry •A20 Appointments and scheduling
•A01 EHR data analysis •A21 Patient consents, authorisations, directives
•A02 EHR data content •A22 Patient demographic services
•A03 EHR data structure •A23 Certificates and related reporting services
•A04 EHR data display •A24 Patient financial and insurance services
•A05 EHR data export/import •A3 Care Supportive services
•A09 EHR generic data attributes •A30 Supportive care service requests (orders)
•A1 Clinical functions •B0 Generic or ubiquitous •A31 Supportive care •B1 Health care enterprises
service reporting (results)
•C3 Directory services
•C0 EHRS functional component
•A10 Clinical: medication management Regional healthcare network
•B01 •A32 Laboratory services Long-term care (institution)
•B10 •C30 Directory: patients
•A11 Clinical: long-term illness management •C1 EHRSdistribution) component
(specific infrastructure services
•A33 Imaging
•B11 General practice Directory: personnel
•C31
•B02 Virtual or telehealth •A34 Diagnostic component
•A12 Clinical: health needs assessment •C10 EHRS Interoperability and therapeutic services (other):
ECG/EEG etc. •B12 Secondary care (hospital) equipment
•C32 Directory:
•A13 Clinical: care planning and care•B03 Personal health Security management component
pathways •C11
•A35 Pharmacy services Tertiary care centre (specialist hospital) directories
•B13 •C33 Directory: health service
•A14 shared care •B04 Community •C2 Knowledge resources
and home care
•B14 Domain specific Directory: service resources
•A4 Analysis and reporting •C34
•A15 Clinical: alerts, reminders and decision support •C20 Knowledge: terminology
•B05 Health, wellness and prevention
Business •B15 Profession specific
•C35 Third parties
•A16 Clinical: workflow and task management •C21 Knowledge: ontology and preventive health
•B06 Occupational health
•A40 Screening
•B2 Secondary uses Profiling or authoring tool
•C4
Functions •C22 Knowledge: archetype reports
•A17 Clinical: patient screening and preventive care services
•B07 Public health
•A41 Care setting
•B20 Research and knowledge discovery
•C5 Documentation, support etc.
•C23 Knowledge: template
•B21 Education •C6 EHR system functional component
•C24 Knowledge: data set
Care Settings •C25 Knowledge: guideline
•B22 Health service and planning

•C26 Knowledge: algorithm
Component Types



Good Practice Requirements - Links



EuroRec Languages (non-exhaustive list)

• English (default language)
• Bulgarian
• Danish
• Dutch
• French
• German
• Italian
• Romanian
• Slovakian
• Slovenian
• Serbian



EuroRec Use Tools

The EuroRec Composer ™
To compose user defined, re-usable and exchangeable baskets of Fine Grained
Statements.

The EuroRec Certifier ™
To format a EuroRec Basket content to obtain the basic layer for the certification of
EHR systems. This is done by adding structure and attributes to the selected Fine
Grained Statements (e.g. mandatory, optional...)

The EuroRec Documenter ™
To document EHR systems and their functions, enhancing their understanding and
comparability by using the EuroRec statements.

The EuroRec Procurer ™
To list and describe, for purchase purposes, required functionalities and product
characteristics using EuroRec statements.

The EuroRec Scripter ™
To produce and link Test Scenarios to EuroRec Baskets for Certification,
Documentation and/or Procurement purposes.



EuroRec stakeholders
(Users of the EuroRec tools)

• National or Regional Healthcare Authorities (quality labelling)

• EHR System providers (self assessment/ product documentation)

• Health IT purchasers (procurement)

• Health IT professional users

• Health IT research and education



Composer
EuroRec
Baskets EuroRec
Repository
Certifier of
Procurer
Documenter Statements

Certification Documentation Procurement

Test Criteria
Sets

Scripter
Test Test
Scenarios Procedures

EuroRec Use Tools



EuroRec at your Service !

1. Developing & maintaining a central repository with quality criteria

7. Developing tools: certification, procurement and product doc.

• Providing guidance and assistance to all stakeholders

• Assisting Authorities in introducing / adopting certification

• Training and accreditation of surveyors (European level)

• Set-up of certification session (incl. scenario scripting/operations)

• Validation of clinical archetypes (clinical models)

• Continous & total Q.A. of processes and procedures



2012 - Gerard Freriks, EuroRec, ProRec.nl 13 mei 2008


EuroRec Seal

• To have a “base” level set of functions
that can be accredited across Europe.

• This will greatly appeal to the supplier industry and allow for
more early stage accreditation of systems across national
boundaries.

• Harmonisation of the certification will favour harmonisation of
products.

• Develop a strong, growing and profitable EHR supplier industry
that can be competitive globally.



Content of the Seal (1)
• Not all EHR functions can - at present - be harmonised
across the European Community:
– Specific regulations (incl. HC reimbursement systems);
– Linguistic and cultural issues;
– Differences in available services (e.g. drug- and other
databases in use);
– Even sometimes different options regarding evidence
based medicine (EBM) issues ! (cf. decision support
modules).
• First versions of the EuroRec seal & criteria will therefore
mainly focus on what is really essential and thus be related
to “ generic ” aspects.
e.g. “the trustworthiness of the content of an EHR”.


Content of the Seal

• The first set of selected criteria will:
– not be too specific, e.g not related to very particular
functions;
– correspond with what is considered essential (e.g.
security, medication management, ....)

• Fair chance that a large number of existing EHR products
will conform to the chosen criteria.



The GPR with most selected FGS



Topics

• Repository
• Tooling

– Implementations
– Conclusions



Seals United Kingdom Austria

Belgium
Spain

Slovenia Bulgaria

Croatia
Slovakia

Cyprus
Serbia

Czech Republic
Romania

Portugal 23 EuroRec Denmark

EHR-Q TN
Poland Quality Seals Estonia

28 Partners
Norway France

25 Countries
Netherlands Germany

Luxembourg Greece

Italy Hungary
Ireland



Topics
– Introduction Semantic Interoperability
– Introduction EHR
– EHR and Quality
• Functional quality
• EuroRec Quality Labeling

– Conclusions



Conclusions

- EuroRec provides:
• European Functional requirements
at the Enterprise level
• Tooling support
• Quality Labeling
• 23 Seals awarded

– Adopt the Belgrade Declaration

The Eurorec repository of Functional EHR Requirements - Gerard Freriks

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