SME Certification

Below is a summary of the most important aspects related to the open SME call. More detailed information can be found in the SME Certification - Pilot Call Description document.

The European Health Data and Evidence Network invites Small and Medium-sized Enterprises (SMEs) in Europe to apply for training and certification to map health data from various formats to the OMOP common data model (CDM).  The EHDEN project aims to create a thriving ecosystem of data sources interested in making their data available for federated analyses in the CDM, and of SMEs who help them map this data into the OMOP format. On this page, you will find relevant information for SMEs willing to become certified.

Why do we need certified SMEs?

The ambitions of the EHDEN project are high. We aim to standardize 100 million patient records across Europe from different geographic areas and data source types, e.g. hospital data, registries, population databases. This implies that for each of the data sources, a custom Extraction Transform and Load (ETL) process has to be developed. A high quality ETL process has several requirements:

  • A high involvement of the data custodian who knows the data and its provenance best.
  • Deep expertise in using the OMOP-CDM and its Standardized Vocabularies.
  • Good programming and engineering skills.
  • Advanced expertise in database management systems.
  • Etc.

The data transformation needs to be of high quality and should follow all best practices with respect to transparency and reproducibility.

Capped funding will be available to data custodians through a “Harmonization Fund” to subsidise mapping performed by certified SMEs. Per data source there is a maximum amount of funding of 100.000 euros. We anticipate a continuously growing market for mappings because of the increasing interest into OMOP CDM. Data custodians are expected to have a strong interest in mapping their data to benefit from being part of the federated EHDEN ecosystem

We expect that those who receive training and certification through EHDEN will actually go on to perform mappings to help build the network. We also hope that they will become active members of the community, sharing ideas and possibly helping to develop or improve data mappings and analysis tools.

Why should your SME participate?

Ultimately, EHDEN aspires to impact how health research is conducted to have a positive impact on patient outcomes. Consequently, there are many stakeholders who will benefit from EHDEN. In particular SMEs, for whom the value created by EHDEN is very tangible. We summarize the most important aspects here:

  • Expand your existing market:
    • Customer base and geographical reach
    • Range of services and products
  • Contribute to the creation of emerging, new markets for data sciences
    • Health data mapping to the OMOP CDM
    • Data analysis services for small and medium biomedical companies
    • Infrastructure design and deployment
    • Enabler of high throughput studies by bridging data users and providers
    • Training on the use of OHDSI tools and observational analyses
    • Ongoing support and maintenance of connected data and provided solutions
  • Early adopters will gain competitive advantage on specialised skill set
  • Possibility to contribute to a change of paradigm benefitting health of citizens
  • Short-term income generation to offset skill investment
  • Free training and certification
  • Open source community boosts opportunities
  • Thriving community facilitates hands-on training of new staff
  • Synergic ecosystem facilitates exposure and brand recognition with key stakeholders

SME application eligibility

The call is open to Small and Medium-sized Enterprises under the official EU definition:

  • < 250 staff headcounts
  • <= € 50m Turnover or <= € 43m Balance sheet total
  • Legally established as a business and based in an EU member state or H2020 associated country.
    • EU member states: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom
    • H2020 associated countries: Albania, Armenia, Bosnia and Herzegovina, Faroe Islands, Georgia, Iceland, Israel, Moldova, Montenegro, North Macedonia, Norway, Serbia, Switzerland, Tunisia, Turkey, Ukraine

See for more details: http://ec.europa.eu/growth/smes/business-friendly-environment/sme-definition_en

SME application evaluation

The application will be evaluated by a SME certification committee that consists of EHDEN consortium members and External members.

The Open Call Evaluation process is structured as follows:

  • Eligibility Check to see if the eligibility criteria have been met. This check is done by the EHDEN PMO and applications failing to meet these criteria will be informed by email.
  • Evaluation by the SME certification committee. Each application will be scored by at least two Committee members using the criteria below and will thereafter be discussed until a consensus is obtained.
    • Score for the expertise/experience in the field. (1-10)
    • Score the perceived capacity to actively engage with the EHDEN community. (1-10)
    • Overall Score to grant the certification training (1-10)
  • Interview with SME. The SME certification committee could decide that a teleconference is needed before a final decision can be made.

SME Training

EHDEN is currently developing the Training and Certification Program together with the OHDSI Community.

In the training program, multiple employees from the SME, that may have different types of expertise, can participate. The aim of the program is that the SME as a company will obtain all the necessary competencies to onboard a data source in the EHDEN federated data network following the established quality standards. This includes, but is not limited to:

  • Foundational Knowledge about the EHDEN project and its objectives.
  • Expertise on the OMOP-CDM and the Standardized Vocabularies.
  • Knowledge about the Extract, Transform, and Load steps and their implementation with OHDSI tools and approaches developed in EHDEN.
  • Understand the fundamentals of proper documentation of the ETL process in close collaboration with the data custodian, to assure transparency and reproducibility.
  • Expertise in the installation and use of the OHDSI Tools for federated data analyses such as those described here: https://www.ohdsi.org/analytic-tools/

A curriculum will be available through online e-learning courses in the EHDEN Academy that focus on all competencies described above (https://academy.ehden.eu).

These courses will contain video lectures, quizzes, tests, etc. Importantly, the curriculum will also contain mapping exercises on simulated datasets (offered through virtual machines). The exercises will be monitored by the EHDEN consortium and support will be offered through an online forum in the training environment.

The final certification will contain a face-to-face training and assessment session in which a data source will be mapped by the SME.

SME Certification

Once the SME receives the certificate it obtains the following privileges:

  • Certified SME Catalogue: All SMEs that are certified will be mentioned on the EHDEN website.
  • Certification Badge: Certified SMEs are allowed to add the EHDEN certification badge to their website.
  • Member of the EHDEN SME Community: During the EHDEN project we like to engage active SME Community that will support the development of the eco-system. This can include invites to additional training sessions, hack-a-thons to improve the open source tools or invites to Study-A-Thons in which researchers and data sources will collaboratively execute studies to generate reliable evidence.