An Inventory of Certification Criteria for EHR Systems

The importance of EHRs quality criteria in Europe

The overall objective of the Q-REC project is to develop methods and to create a mechanism for the quality labelling and certification of Electronic Health Record systems (EHRs) in Europe, in primary and acute hospital care settings. Several EU member states have already proceeded with EHRs quality labelling and/or certification, more often in primary care, but these differ in scope, in legal framework under which they operate, in policies and organisation, and perhaps most importantly in the quality and conformance criteria used for benchmarking. This means that the requirements, functionality and quality of EHR systems is at present a patchwork across Europe, leaving:

• purchasers of EHR systems to struggle with a piecemeal market of non-comparable systems;
• users and clinical governance organisations to contend with inconsistent functionality on which to attempt to harmonise evidence based care;
• vendors with heterogeneous and volatile user requirements against which to build systems and a fragmented European market within which to try to sell products.

EuroRec will act as central repository of validated quality criteria and other relevant materials that can be used to harmonise the European testing, quality labelling and procurement specification of EHR systems. EuroRec will also consolidate best practice in testing and certification procedures, including the business models that have proven successful across Europe and internationally. It will not impose particular certification models or specific criteria on any member country but will foster, via its ProRec Centres, the progressive adoption of consistent and comparable approaches to EHR system quality labelling.

Current standing of criteria selection

EuroRec's short term strategy was to firstly collect high priority criteria from existing certification systems in Europe (and worldwide) and to analyse how they could be used in formal certification procedures. Over 1400 functional and other criteria have been analysed and have resulted in this first limited and very preliminary list of EHRs quality criteria.

This initial list covers:

• Clinical: medication management
• Clinical: health assessment and diagnose documentation
• Clinical: care planning, shared care and care pathways
• Clinical: findings and result documentation
• Clinical: alerts, notifications and reminders
• Patient demographic services
• Security: Privacy in general
• Security: technical

Next steps

It is EuroRec's intention to further refine the list, to rigorously index the criteria and to submit the list to external reviewers (with the help of a wide range of stake-holders: EHR industry, authorities, users...). The aim is to obtain a quality labelling (filter) system enabling :

• potential buyers to identify their needs and requirements (specifying their contexts of use, the type of EHR modules they need etc.) and to find appropriate test plans with scenarios and criteria against which a number of EHRs may be tested;
• EHR-system-developers and vendors to check their own systems to get a quality label or certificate or to better plan future development;
• EU member states to implement EHRs certification in a comparable way.