Collecting and Handling Health Data in a GDPR World
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1 Collecting and Handling Health Data in a GDPR World Alexander Whalen, Senior Policy Manager,
2 WHO IS Represents the digital technology sector in Europe A wide range of Multinational Companies (60) and National Trade Associations (37) Represents more than 27,000 businesses and 2 million employees HIMSS Europe GmbH 2
3 WHERE ARE WE TODAY? Sensitive personal data includes data concerning health Directive 95/46/EC Afforded higher standard of protection General prohibition of processing without explicit consent Some level of fragmentation across EU with sub-categories HIMSS Europe GmbH 3
4 WHERE WILL WE BE IN MAY 2018? Regulation vs. Directive General Data Protection Regulation ( GDPR ) More organisations caught by scope New safeguards requirement Increased transparency Higher fines HIMSS Europe GmbH 4
5 TRANSPARENCY AS A CORE FOCUS Certain information needed to explain use of personal data GDPR requires more info: Will data be transferred? How long will it be kept? Is profiling being used? HIMSS Europe GmbH 5
6 EXPANSION OF SENSITIVE PERSONAL DATA GDPR continues to include health data GDPR includes genetic and biometric data GDPR permits Member States to introduce further conditions HIMSS Europe GmbH 6
7 MORE ORGANISATIONS CAUGHT Processors are subject to direct legal obligations Organisations not established in the EU require compliance HIMSS Europe GmbH 7
8 PROCESSING HEALTH DATA Lawful processing reflects Directive Explicit consent is not the only option Lawful processing also for public interest, preventative or occupational medicine, medical diagnosis, provision of health or social care or treatment, etc. Questions remain on scientific research HIMSS Europe GmbH 8
9 HOW TO OBTAIN CONSENT? Freely given, specific, informed and unambiguous indication of individual's wishes GDPR places burden on controller to demonstrate consent Must be obtained in a manner distinguishable from other matters, in an easily accessible form and using clear and plain language HIMSS Europe GmbH 9
10 IMPORTANCE OF SCIENTIFIC RESEARCH Qualified compliance framework if safeguards in place No clear definition on scientific research What about health research, driven primarily for commercial gain? HIMSS Europe GmbH 10
11 SCIENTIFIC RESEARCH VS. RIGHTS OF INDIVIDUALS GDPR strengthens individuals rights Introduction of new rights like data portability Scientific research tempers effects of some rights (e.g. right to erasure & right to object) Member State derogations exist HIMSS Europe GmbH 11
12 DATA BREACH NOTIFICATION Not industry specific Triggered if breach likely to result in high risk to individuals Nature of health data likely to result in high risk to individuals if breached Conditions on breach HIMSS Europe GmbH 12
13 DOCUMENTATION & MORE DOCUMENTATION Controllers & processors now have documentation obligations Record of processing activities must be kept Nature of health data likely to result in high risk to individuals if breached Conditions on breach HIMSS Europe GmbH 13
14 APPOINTING DATA PROTECTION OFFICER Obligation to appoint DPO when core activities consist of the processing of sensitive data on a large scale This will catch large amount of: Healthcare providers; Insurance Pharma Biotech Digital tech HIMSS Europe GmbH 14
15 WHAT S LEFT TO BE DONE? Article 29 Working Party guidance documents Aim is to give clarity to controllers and processors Published in draft form for stakeholder input Data Protection Impact Assessments next HIMSS Europe GmbH 15
16 ANYTHING ELSE? Codes of conduct & certification Adherence to either to be used as sign of compliance Health industry can explore developing a code tailored for their specific requirements Certified controllers or processors also option HIMSS Europe GmbH 16
17 IS THAT REALLY ALL? Ensure harmonised implementation across Member States Minimise (or maximise) Member State opening clauses Ensure clarity in unclear areas HIMSS Europe GmbH 17
18 Thank you! Alexander Whalen, Senior Policy Manager,
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