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GDPR (General Data Protection Regulation)

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Is Privacy Obsolete Study

Meeting to produce a Whitepaper

Mondays at 10:00 am Eastern Time See HL7 Calendar item

Whitepaper proposed Outline

  1. Introduction and Scope -- that will explain we are only addressing FHIR specific topics
  2. Mapping of GDPR Articles to the existing Security or Privacy capability in FHIR -- this section will provide terse guidance on how we visualize the use.
  3. Identification of some gaps we identified -- nothing critical, mostly nice-to-have operations
  4. Conclusion -- FHIR is GDPR enabling

The whitepaper will be published on the HL7 confluence page: FHIR - GDPR

Conference Calls Agenda and Minutes:

Call details: Security WG FreeConference web meeting

Online Meeting ID: security36

Dial-in Number: (515) 604-9567

Access Code: 880898

GDPR Background

The handbook has been prepared by the EU Agency for Fundamental Rights (FRA), with the Council of Europe (together with the Registry of the European Court of Human Rights) and the European Data Protection Supervisor.

This handbook outlines the legal standards relating to data protection set by the European Union (EU) and the Council of Europe (CoE). It is designed to assist practitioners not specialised in the field of data protection, including lawyers, judges and other legal practitioners, as well as individuals working for other bodies, such as non-governmental organisations (NGOs), who may be confronted with legal questions relating to data protection. The handbook serves as a first point of reference on relevant EU law and the European Convention on Human Rights (ECHR), as well as the CoE Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (Convention 108) and other CoE instruments.

GDPR Presentations and Papers

GDPR Connectathon May 2018

GDPR Vocabulary

GDPR Implementation by Country

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.

GDPR Articles

The companies are accused of forcing users to consent to targeted advertising to use the services. Privacy group led by activist Max Schrems said people were not being given a "free choice". If the complaints are upheld, the websites may be forced to change how they operate, and they could be fined.

UMA Legal