Certificationof

EHR SystemsHISI 2011 1

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

10 GOOD REASONS TO ADOPT EHR SOLUTIONS

To access any time anywhere

Store & Retrieval

To share information

Improved cost efficiency of care

Improve care through decision support, surveillance and monitoring of care

Improve care management

Improve record / practice management

Patient empowerment

Tracability - Reliability - Responsability Manag.

Re-usability of information

0 5 10 15 20 25 30Level 1 Level 2 Level 3 Level 4 Level 5

HISI 2011 3

Barriers to AdoptingPrimary barriers

Financial

High Start-up Costs 12High On-going Costs 11Return on Investment (ROI) Uncertainty 8Lack of Financial Resources 2

Technical

Lack of computer skills of the physicians and/or Staff 10Lack of technical training and support 9Complexity of the system 2Limitation of the system 2Lack of Customizability 5Lack of Reliability 3Interconnectivity/Standardization 8Lack of computers/hardware 2

Time

Time to select, purchase and implement the system 5Time to learn the system 7Time to enter data 6More time needed per patient 8Time needed to convert the records 2

HISI 2011 4

Barriers to Adopting

Psychological

Lack of belief in EHRs

Secondary barriers

Need for control (loss of control or influence)

Social

Uncertainty about the vendorLack of support from external partiesInterference with doctor-patient relationshipLack of support from other colleaguesLack of support from the management level

Legal Privacy or security concerns

OrganizationalOrganizational sizeOrganizational type

Change Process

Lack of support from organizational cultureLack of incentivesLack of participationLack of leadership

HISI 2011 5

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

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

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

Reasons why a country might opt for certification

Improve market deployment and product development

Stimulate competition on quality and reduce market fragmentation

Validated privacy protection

Improving the quality of the care by improving the quality of the content based on related criteria

Improve EHR Procurement

Increase compliance to user and use quality requirements

Have a reliable data source for secondary use

Improved patient safety in care

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

Increasing quality of the products through coherent and pre-tested functionality

Assured compliance to national rules and standards

0 2 4 6 8 10 12 14 16 18

Level 1 Level 2 Level 3 Level 4 Level 5

HISI 2011 9

Stakeholders

• Health Authorities• Initiators• Enablers, Facilitators• Responsible• Delegation

– Buyers– Health Professionals– Patients– Industry

HISI 2011 10

Certification body

CAB

InitiatorIAF

Product

Supplier Authority

Accreditation body

Certificate

Label

HISI 2011 11

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

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

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

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

Building blocks

• EuroRec• 1.700 functional descriptive statements

• IHE

HISI 2011 16

Overlaps

HISI 2011 17

Sustaining certification

Create a relation of trust and partnership between authorities, users and industry.

Increase economic viability of the suppliers by supporting the use of certified EHR systems and stimulating defragmentation of the market.

Costs need to be shared between health authorities and the industry, industry e.g. paying the effective testing / assessment only

Develop and support a common “language” to describe functional requirements in a comparable way: national repository of reusable statements publically available.

Functional assessment and “interoperability” assessment should be offered by on Health IT Quality Institute.

Costs need to be supported by the health authorities.

Develop and support a common “language” across Europe to describe functional requirements enabling portability across Europe: European repository of nationally reusable statements publically available.

Organise cross border recognition of tested functions.

Costs should be supported by the product suppliers

Develop quality assessment and certification as a “public service” with / without subcontracting.

Functional assessment and “interoperability” assessment should be kept as distinct procedures.

0 2 4 6 8 10 12 14

Level 1 Level 2 Level 3 Level 4 Level 5

HISI 2011 18

Conclusions

• May be hard to see now• But its coming …• 4 Speed Europe

HISI 2011 19

HISI 2011 20