GDPR (General Data Protection Regulation)

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GDPR Background

• Useful GDPR regulation text reference
• Special Eurobarometer 395 Attitudes on Data Protection and Electronic Identity in the European Union

GDPR Presentations and Papers

• Standards support for key GDPR Policies - Rene Spronk
• Impact of the GDPR on the use of interoperability standards- Rene Spronk

• IHE Whitepaper on GDPR

• HIMSS - What Healthcare Organizations need to know about the GDPR and HIMSS Presentation recording

• Guide to the General Data Protection Regulation - Bird&Bird
• GDPR is good for HL7 and standardization HL7 May 2018 Cologne - Petra Wilson
• Bernd Blobel EU Data Protection Regulation

GDPR Connectathon May 2018

• GDPR Presentation for May 2018 Connectathon - Alex Mense

• May Cologne Connectathon 201805 GDPR

• GDPR Connectathon Spreadsheet

GDPR mHealth Apps

• mHealth Code to Aid App Developers in the EU Privacy Code of Conduct for mHealth apps was drafted by a working group set up in January this year and the final draft was published on 7th June and submitted to the Article 29 Working Party for their consideration and approval. If and when it receives the Working Party’s approval it could then be relied upon by app developers wishing to demonstrate a good standard of data protection compliance. The Code is an example of the type of initiative that is increasingly likely to develop under the forthcoming EU General Data Protection Regulation (GDPR). The second section of the Code sets out the practical guidelines. These are:

1. Consent of users: the need to obtain valid explicit consent from the data subject to collect and use their data
2. Data Protection Principles – Purpose Limitation, Data Minimisation, Transparency, Privacy by design and privacy by default and data subject rights: these reflect principles at the heart of EU Data Protection rules
3. Information to provide to users before they use the app: guidance on adopting a layered notice approach and using a condensed notice and full privacy policy
4. Data Retention: the Code acknowledges that it can be difficult to irreversibly anonymise health data when the retention period expires
5. Security: the requirement to carry out a Privacy Impact Assessment and adopt security measures recommended by ENISA
6. Advertising on the app: any advertising must be authorised by the user but there is a difference in approach depending on whether the advertising involves the processing of personal data
7. Use of data for secondary purposes: in instances where data could be used for scientific research or other big data analysis
8. Disclosing data to third parties: ensuring that there’s an agreement in place with the third party is essential
9. Data Transfers: complying with the rules around international data transfers
10. Data Breach: what to do and whom to notify when a data breach occurs
11. Children’s data: when apps are deliberately aimed at children

Posted on June 17th, 2016 By Victoria Hordern. Posted in Health Privacy/HIPAA, International/EU Privacy

• Trust in mHealth apps: As revealed by the European Commission's 2014 mHealth Green Paper consultation, people often do not trust mHealth apps, such as those monitoring your health or giving health advice. Respondents to the mentioned consultation considered that having users' consent as well as strong privacy and security tools in place is a crucial issue in relation to mobile health apps.

• Final draft of the Code of Conduct on privacy for mHealth apps
• Green Paper on mobile health

UMA Legal

• IACCM Contracting Principles International Association for Contract and Commercial Management
• UMA Legal role definitions March 2018