With the rapid development in health data science in recent years, in particular around electronic healthcare records and associated coded outcomes, there now exists a gap between technical innovation and robust clinical evidence. The meetings with key stakeholders aimed to guide future research and clinical decision support by raising awareness of current limitations and providing a framework for best practice approaches for (1) ascertaining the quality and adequacy of coding and (2) integration and harmonisation.
A first on-line stakeholder meeting was organised on July 7th, 2020 to discuss the coding standards and the impact on trials. It gathered together around 50 relevant experts (i.e. regulators, journal editors, representatives from industry, payers, patients and cardiology professionals within the ESC).
The October virtual stakeholder meeting was focused on social aspects. It included some short presentations on social license, patient perspective and regulatory decision making from thought leaders, and four break-out sessions:
- Patient concerns & privacy;
- Technical process & data stewardship;
- Publication process & requirements;
- Implementation into practice of EHR studies (regulatory to practice).
Then, experts have been re-directed to the plenary session.
There will be an iterative process, so the July meeting, the October meeting and offline communications and drafts will all contribute to a final white paper.