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2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
The Eurorec repository of Functional
EHR Requirements
(Lodz, 29 November 2012)
Gerard Freriks EuroRec
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Topics
– EHR and ISO RM/ODP Viewpoints
– EuroRec Association
– EHR Functional Requirements
• Repository
• Tooling
– Implementations
– Conclusions
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Topics
– EHR and ISO RM/ODP Viewpoints – EuroRec Association
– EHR Functional Requirements
• Repository
• Tooling
– Implementations
– Conclusions
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
6
MIE2012 - Village of the Future
M. Rigby/J. Hofdijk
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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.
Electronic Health Records (EHR)
8
© EN13606 Association
EHR and standards
8 SemanticHealthNet Dipak Kalra
HISA
13606
Continua
...
SNOMED
WHO
LOINC
...
ContSys
...
PMAC ...
9
© EN13606 Association
EHR - Privacy
9
ACL ACL ACL
ACL
ACL
ACL Trust
Flexibility
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Common
Trusted
Facilities
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Trust
Payload Semantic Stack
Web Services
C++, Java, ... Windows, Linux
Hardware Platforms
FUNCTIONAL
Requirements
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Topics
– EHR and ISO RM/ODP Viewpoints
– EuroRec Association – EHR Functional Requirements
• Repository
• Tooling
– Implementations
– Conclusions
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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)
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
“ Differences in languages, cultures and HC-delivery/funding systems ”
Austria
Belgium
Bulgaria
Denmark
France
Italy
Germany
Ireland
Romania
Slovenia
Spain
Slovakia
Serbia
The Netherlands
United Kingdom
Established ProRec Centers
Cyprus
Czech Republic
Greece
Hungary
Norway
Poland
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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…?
eHealth Stakeholders
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Clinician
Clinical Trials & Research
Safety and Adverse Event
Registers
EHR (EMR, EPR…)
Decision Support Systems
Marketing
Billing
Knowledge Mgmt
Platforms
Privacy Enhancing Techniques
Patient
PHR
TRUST
Healthcare Management
Secondary use of (medical) data
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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)
-...
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Topics
– EHR and ISO RM/ODP Viewpoints
– EuroRec Association
– EuroRec
EHR Functional Requirements
• Repository
• Tooling
– Implementations
– Conclusions
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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.
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Benefits for the Stakeholders
Industry
EHRs - Quality Labelling / Certification
Market ( R.O.I.)
Quality and Safety Efficiency of HC Delivery Systems
Health Services Management
Patients, Clinicians
Public Health Health Authorities
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
• 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
• ...
A growing number of strategic eHealth projects
are or become certification dependent, e.g.:
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Pressure
New functions
New instruments
€ 1
2
3
4
Certification: a powerful weapon…
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
• 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.
•Existing “national” certification
• Foreseen within 1-2 years
• Considered
“National” Certification in Europe
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Recommendations
by the EHR-QTN Consortium
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
“ 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
Belgrade Recommendations
by the EHR-QTN Consortium
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Belgrade Recommendations
by the EHR-QTN Consortium
(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.
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Belgrade Recommendations
by the EHR-QTN Consortium
(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.
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Topics
– EHR and ISO RM/ODP Viewpoints
– EuroRec Association
– EuroRec: EHR Functional Requirements
• Repository
• Tooling
– Implementations
– Conclusions
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
EuroRec’s Workflow
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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)
•C0 EHRS functional component
•C1 EHRS infrastructure component
•C10 EHRS Interoperability component
•C11 Security management component
•C2 Knowledge resources
•C20 Knowledge: terminology
•C21 Knowledge: ontology
•C22 Knowledge: archetype
•C23 Knowledge: template
•C24 Knowledge: data set
•C25 Knowledge: guideline
•C26 Knowledge: algorithm
•C3 Directory services
•C30 Directory: patients
•C31 Directory: personnel
•C32 Directory: equipment
•C33 Directory: health service directories
•C34 Directory: service resources
•C35 Third parties
•C4 Profiling or authoring tool
•C5 Documentation, support etc.
•C6 EHR system functional component
•B0 Generic or ubiquitous
•B01 Regional healthcare network (specific distribution)
•B02 Virtual or telehealth
•B03 Personal health
•B04 Community and home care
•B05 Health, wellness and prevention
•B06 Occupational health
•B07 Public health
•B1 Health care enterprises
•B10 Long-term care (institution)
•B11 General practice
•B12 Secondary care (hospital)
•B13 Tertiary care centre (specialist hospital)
•B14 Domain specific
•B15 Profession specific
•B2 Secondary uses
•B20 Research and knowledge discovery
•B21 Education
•B22 Health service and planning
•A0 EHR data (record) management
•A00 EHR data entry
•A01 EHR data analysis
•A02 EHR data content
•A03 EHR data structure
•A04 EHR data display
•A05 EHR data export/import
•A09 EHR generic data attributes
•A1 Clinical functions
•A10 Clinical: medication management
•A11 Clinical: long-term illness management
•A12 Clinical: health needs assessment
•A13 Clinical: care planning and care pathways
•A14 shared care
•A15 Clinical: alerts, reminders and decision support
•A16 Clinical: workflow and task management
•A17 Clinical: patient screening and preventive care services
•A2 Administrative services
•A20 Appointments and scheduling
•A21 Patient consents, authorisations, directives
•A22 Patient demographic services
•A23 Certificates and related reporting services
•A24 Patient financial and insurance services
•A3 Care Supportive services
•A30 Supportive care service requests (orders)
•A31 Supportive care service reporting (results)
•A32 Laboratory services
•A33 Imaging services
•A34 Diagnostic and therapeutic services (other): ECG/EEG etc.
•A35 Pharmacy services
•A4 Analysis and reporting
•A40 Screening and preventive health
•A41 Care setting reports
Component Types
Care Settings
Business
Functions
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Good Practice Requirements - Links
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
EuroRec Languages (non-exhaustive list)
• English (default language) • Bulgarian • Danish • Dutch • French • German • Italian • Romanian • Slovakian • Slovenian • Serbian
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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 Use Tools
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
• 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
EuroRec stakeholders
(Users of the EuroRec tools)
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Test
Procedures
EuroRec
Baskets
Certification Documentation Procurement
Test
Scenarios
Test Criteria
Sets
EuroRec
Repository
of
Statements
Composer
Procurer
Documenter
Certifier
Scripter
EuroRec Use Tools
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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
EHR-Qᵀᴺ Polska 2012
13 mei 2008
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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.
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
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”.
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
• 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.
Content of the Seal
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
The GPR with most selected FGS
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Topics
– EHR and ISO RM/ODP Viewpoints
– EuroRec Association
– EHR Functional Requirements
• Repository
• Tooling
– Implementations – Conclusions
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Austria
Ireland
United Kingdom
Belgium
Czech Republic
Hungary
Greece
Germany
France
Estonia
Denmark
Bulgaria
Croatia
Cyprus
Italy
Luxembourg
Netherlands
Norway
Poland
Portugal
Romania
Serbia
Slovakia
Slovenia
Spain
Seals
EHR-Q TN 28 Partners 25 Countries
23 EuroRec
Quality Seals
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Topics
– Introduction Semantic Interoperability
– Introduction EHR
– EHR and Quality
• Functional quality
• EuroRec Quality Labeling
– Conclusions
2012 - Gerard Freriks, EuroRec, ProRec.nl
EHR-Qᵀᴺ Polska 2012
Conclusions
- EuroRec provides: • European Functional requirements
at the Enterprise level
• Tooling support
• Quality Labeling
• 23 Seals awarded
– Adopt the Belgrade Declaration