1. LEGAL ASPECTS OFBIG DATA ANALYSESMEDICA21 November 2013Sofie van der Meulenwww.axonlawyers.com

2. OverviewBig Data vs. Big Intelligence Big Data and Data Protection Looking forward: the General Data ProtectionRegulation 3. Big Data 4. Big Intelligence 5. Big Data - EUEU Council Summit 24/25 October 2013:"EU action should provide the right frameworkconditions for a single market for big dataEuropean Commission Digital Agenda for Europe:https://ec.europa.eu/digital-agenda/en/making-big-data-work-europehttp://ec.europa.eu/digital-agenda/en/news/big-data-what-it-and-why-it-importantMemo European Commission 7 November 2013:http://europa.eu/rapid/press-release_MEMO-13-965_en.htm 6. Data ProtectionData Protection Directive (95/46/EC)Processing of special data (health): article 8 DPD Informed consent vs. the principle of purposelimitation Consent: any freely given specific and informedindication of his wishes by which the data subjectsignifies his agreement to personal data relating tohim being processed. Special data? Explicit consent(see article 29 WP Opinion 15/2011). The right to withdraw consent(data must be deleted if data subject no longer wants itsdata to be processed) 7. General Data Protection RegulationDerogations to consent: article 81 and 83 GDPRArticle 81 (1b) of the GDPR:Consent for the processing of medical data may bewithdrawn at any time.Article 83 GDPR: Personal health data may beprocessed if:- Consent or anonymised patient dataGDPR: Consent is required to maintain valuabledatasets, but consent can be withdrawn at any timemaking compliance uncertain! 8. General Data Protection RegulationData portability (article 18)right to access data and ask for a electronic copy of alldata and right to transfer the data to other platforms andservices.! Compliance is difficultProfiling (article 20)Limits to "profiling, a technique used to analyse orpredict a person's performance at work, economicsituation, location, health, preferences, reliability orbehaviour based on the automated processing of his/herpersonal data. 9. Genetic data - consentGenetic data: special form of consent.Article 4a proposal IVD Regulation:A device may only be used for thepurpose of a genetic test after the testsubject concerned has given free andinformed consent to it. That consent shallbe given explicitly in writing. The consentmay be revoked at any time in writing ororally 10. MEDICA21 November 2013www.axonlawyers.comTHANK YOU FOR YOURATTENTIONSofie van der MeulenAxon LawyersPiet Heinkade 1831019 HC AmsterdamT +31 88 650 6500F +31 88 650 6555M +31 6 53 440 567E sofie.vandermeulen@axonlawyers.comREAD THIS BLOG:http://medicaldeviceslegal.com 11. Legal stuff The information in this presentation is provided for informationpurposes only. The information is not exhaustive. While every endeavour is madeto ensure that the information is correct at the time of publication,the legal position may change as a result of matters including newlegislative developments, new case law, local implementationvariations or other developments. The information does not take into account the specifics of anyperson's position and may be wholly inappropriate for yourparticular circumstances. The information is not intended to be legal advice, cannot berelied on as legal advice and should not be a substitute for legaladvice.