COCIR has recently released three documents:
- A position paper articulating COCIR views on the General Data
- A detailed contribution providing more insight and concrete
examples on healthcare;
- Suggestions for amendments to the draft Regulation being
currently discussed at European Parliament and European Council levels
In addition, COCIR joined the Industry Coalition on General Data Protection Regulation and co-signed the Statement 'Reforming Europe’s Privacy Framework - How to find the right balance".
COCIR continues active discussions with the European Institutions in order to bring attention on potential consequences of the General Data Protection Regulation on the Healthcare sector.
COCIR’s main recommendations to improve the General Data Protection Regulation are:
- Clarify definitions (Art. 4): The use of anonymised, pseudonymised or key–coded data by the healthcare and research sectors should be facilitated by the Regulation. Article 4 should recognise that data which cannot identify the data subject (e.g. anonymised data); data which are not directly associated to the data subject (e.g. technical data) or data which require unreasonable time and effort to identify the data subject (e.g. pseudonymised data) are not personal data and are not subject to the Regulation.
- Maintain clear and separate responsibilities between the healthcare provider and the medical technology provider, as per the current regime (Art. 28- 33- 34- 77).The relationship between the healthcare provider and the medical technology provider should be managed by contract, not by law.
- Reduce administrative burden (Art. 26): In an environment
where outsourcing is part of the business mode and care delivery, seeking
approval of the healthcare provider before enlisting other medical technology
providers generates administrative burden on both sides, without bringing
benefits to privacy. Allow processing of data concerning health by medical
technology manufacturers for maintenance and equipment performance evaluation
purposes (Art. 81 - 83): Professionals employed by medical technology
manufacturers (technicians, engineers, medical professionals), should be able
to access data concerning health for technical maintenance and equipment
For more information please visit www.cocir.org