2. FEED BACK FROM 2 EU PROJECTS
EHR – Implemement
analysed implementation experience in 10
countries
EHR - QTN
evaluating the importance and possible impact
of having well documented good quality and
reliable EHR systems on the market and users.
HISI 2011 2
3. 10 GOOD REASONS TO ADOPT EHR SOLUTIONS
Re-usability of information
Tracability - Reliability - Responsability Manag.
Patient empowerment
Improve record / practice management
Improve care management
Improve care through decision support, surveillance and…
Improved cost efficiency of care
To share information
Store & Retrieval
To access any time anywhere
Level 1 Level 2 0
Level 3 5
Level 4 10Level 5 15 20 25 30
HISI 2011 3
4. Barriers to Adopting
High Start-up Costs 12
High On-going Costs 11
Financial Return on Investment (ROI)
Uncertainty 8
Lack of Financial Resources 2
Lack of computer skills of the
physicians and/or Staff 10
Lack of technical training and
support 9
Primary barriers
Complexity of the system 2
Technical Limitation of the system 2
Lack of Customizability 5
Lack of Reliability 3
Interconnectivity/Standardizat
ion 8
Lack of computers/hardware 2
Time to select, purchase and
implement the system 5
Time to learn the system 7
Time Time to enter data 6
More time needed per patient 8
Time needed to convert the
records 2
HISI 2011 4
5. Barriers to Adopting
Lack of belief in EHRs
Psychological
Need for control (loss of control or
influence)
Uncertainty about the vendor
Lack of support from external
parties
Interference with doctor-patient
Social relationship
Secondary barriers
Lack of support from other
colleagues
Lack of support from the
management level
Legal Privacy or security concerns
Organizational size
Organizational
Organizational type
Lack of support from
organizational culture
Change Process Lack of incentives
Lack of participation
Lack of leadership
HISI 2011 5
6. EFFECTIVE USE
EHR-Implement issued two concrete
recommendations:
• Application selection should be the subject of
detailed user evaluation to ensure local
processes; workflow and functional needs are
taken into account.
• Vendors selection must be the subject of a
thorough due diligence process to ensure that
both the EHR software and vendor organisation
are fit for purpose.
HISI 2011 6
7. EFFECTIVE USE
Selecting the most appropriate application from the correct vendor is a real challenge
Quality assessment, labelling and certification of the systems can fulfil an important role
when procuring an application.
They offer, considering the trustworthiness of the procedure, a guarantee of compliance
with standards, legal and user requirements, of course as far as they are tested against
pre-defined and comparable / similar criteria.
HISI 2011 7
8. Effective Use
• “There is a large gap between the postulated
and empirically demonstrated benefits of
eHealth technologies. In addition, there is a
lack of robust research on the risks of
implementing these technologies and their
cost-effectiveness has yet to be demonstrated”
HISI 2011 8
9. Reasons why a country
might opt for certification
Assured compliance to national rules and standards
Increasing quality of the products through coherent and pre-tested functionality
Leverage exchange of health (care) related data and interoperability of systems
Improved patient safety in care
Have a reliable data source for secondary use
Increase compliance to user and use quality requirements
Improve EHR Procurement
Improving the quality of the care by improving the quality of the content based on related criteria
Validated privacy protection
Stimulate competition on quality and reduce market fragmentation
Improve market deployment and product development
0 2 4 6 8 10 12 14 16 18
Level 1 Level 2 Level 3 Level 4 Level 5
HISI 2011 9
10. Stakeholders
• Health Authorities
• Initiators
• Enablers, Facilitators
• Responsible
• Delegation
– Buyers
– Health Professionals
– Patients
– Industry
HISI 2011 10
11. Initiator
IAF
Supplier Authority
Accreditation
body
Certification
body Certificate
Label
CAB
Product
HISI 2011 11
12. Verification and Validation of
Software
• Verification attempts to answer to the
question “is the software built right?”
• Validation attempts to answer to the question
“is the right software built?”
HISI 2011 12
13. Approaches to Certification
• EHR-QTN approach
• Third party assessment
• quality label
• Self-assessment with an external audit
• declaration of quality.
• HITCH approach
• LabelCert of products
• Self-assessment with external audit
• KITH approach
• Self-declaration based on high level description of key
requirements
• Self-declaration based on formal, verifiable
requirements HISI 2011 13
14. What Works best
• Third party assessment is the most suitable
procedure for the still immature market of
EHR systems.
• Comprehensive or progressive testing
– The EuroRec Repository
• Modular quality labelling and certification
– Eurorec “baskets” of criteria
HISI 2011 14
15. Related Issues
• Quality labels and certificates are primarily
national.
• It is strongly recommended to start small”,
• Impact of the Medical Devices Directive
2007/47/EC
– The IEC 62304 standard
• Applicable to eHealth and EHR systems?
• The Canadian Experience
• Difficult area
• HISI 2011 15
18. Sustaining certification
Functional assessment and “interoperability” assessment should be kept as distinct procedures.
Develop quality assessment and certification as a “public service” with / without subcontracting.
Costs should be supported by the product suppliers
Organise cross border recognition of tested functions.
Develop and support a common “language” across Europe to describe functional requirements enabling
portability across Europe: European repository of nationally reusable statements publically available.
Costs need to be supported by the health authorities.
Functional assessment and “interoperability” assessment should be offered by on Health IT Quality
Institute.
Develop and support a common “language” to describe functional requirements in a comparable way:
national repository of reusable statements publically available.
Costs need to be shared between health authorities and the industry, industry e.g. paying the effective
testing / assessment only
Increase economic viability of the suppliers by supporting the use of certified EHR systems and stimulating
defragmentation of the market.
Create a relation of trust and partnership between authorities, users and industry.
0 2 4 6 8 10 12 14
Level 1 Level 2 Level 3 Level 4 Level 5
HISI 2011 18
19. Conclusions
• May be hard to see now
• But its coming …
• 4 Speed Europe
HISI 2011 19
