Enriching knowledge and enhancing care through health data

Ensuring the trustworthy reuse of health data for research

European projects, future call topics for Horizon 2020 proposals, national research infrastructure programmes and Real World Data initiatives from Pharma, all point to the growing interest amongst many stakeholders to collaborate, and tackle at a large scale, access to high-quality, integrated and appropriately protected health data to conduct research. Concerns about the protection of privacy when health data are integrated or shared, even for direct patient care as well as for aggregated data purposes, limit the extent to which even the data we have today can be combined, aggregated and analysed appropriately. However, a number of European initiatives are making progress in addressing these issues and are generating solutions for the reuse of health data for research that are ready to be adopted, at scale.

EHR4CR has developed an innovative platform that can connect securely to the data within multiple hospital EHR systems across Europe, to enable a trial sponsor to estimate, in close to real time, the patient numbers corresponding to the inclusion and exclusion criteria of a candidate clinical trial protocol, to assess its feasibility and to locate the most relevant sites. Tools deployed locally can assist each participating hospital to efficiently identify and contact the relevant patients. This platform and services are now being launched by the first commercial service provider, Custodix, ready for Europe-wide deployment and use.

EMIF, the European Medical Information Framework is creating an environment that allows the efficient reuse of existing health data. There are three distinct aspects to EMIF:

  1. EMIF-AD, focusing on the onset of Alzheimer's disease
  2. EMIF-Metabolic, concentrating on the metabolic complications of obesity
  3. EMIF-Platform, a common information framework addressing the practical challenges of locating, classifying and re-using existing health data.

The EMIF Platform will allow authorised access to multiple, diverse data sources, at present spanning primary and secondary care data from nearly 48 million subjects in seven European countries. EMIF will integrate data cohorts and conduct data source profiling, allowing researchers to browse metadata, providing them with a single point of access for searching aggregated data across different sources and countries, and enabling them to answer specific research questions on identifying and validating novel biomarkers.

For both projects, it has been important to establish information governance, privacy protection and information security measures that enable their large scale reuse of health data, without explicit patient consent and yet in full compliance with the applicable legislation, and in a way that is societally acceptable.

The not-for-profit European Institute for Innovation through Health Data (i~HD) has been established to support the governance and sustainability of these initiatives. i~HD will ensure that all parties involved in the EHR4CR ecosystem operate in full compliance with all applicable requirements and policies, by certifying the ICT systems, overseeing their operation, auditing the information flows and establishing good practices in information governance for all service providers, hospitals, and research sponsors. It is developing and promoting best practices for the wider use of EHRs for research, including engagement with patient associations, privacy protection agencies and regulatory authorities to ensure the solution is well accepted by all of them, and generates benefits.

i~HD information governance services

  • Quality labelling criteria for the platform and services, including components deployed at hospitals, and in other data sources
  • Codes of Practice for feasibility studies and for remote data access and sharing
  • Standard Operating Rules
    • Legal requirements and their implementation through specific technical safeguards and specified duties, to ensure proper use of the platform
  • Standard Operating Procedures
    • Access Controls, Incident Management, Audit & Monitoring, Study Management, Organisation Management
  • Staff competence checklist and training resources about data management and privacy protection when using the platform
    • for hospital staff, pharma and academic research staff
    • for platform service providers
  • i~HD Information Governance Board, providing oversight