Regulatory and legal issues related to Blockchain applications in Health and “decision tree” improvement

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26 Jun 2019
Group(s) submitting the application: 
Meeting objectives: 

6 months after the “state of the Art” report on uses and impact of Blockhain in Health, presented at P13 in Philadelphia, this session aims at describing the legal and regulatory framework of blockchain applications in Health, foreseen as second step of the WG activities. The session aims at highlighting main issues related to using blockchain in compliance with data protection standards, with special regard to the EU GDPR, the “reference legal framework” for personal data sharing and processing. In fact, even if blockchain technology is giving proof of high security levels, the nature of the technology itself and how it applies to health data is a complex and multifaceted issue that still poses challenges in real-world implementation .

In the last part of the session, building on the outcomes of P13 meeting, this session aims at brainstorming the decision tree implemented as a framework ,providing non-experts with basic elements for: 1) understanding blockchain usability in a variety of use cases, on the basis of use cases’ requirements; 2) understanding the most appropriate design of a blockchain solution for a given use case. During the session, specific use cases selected with the support of the group’s members, will be discussed using the above-mentioned framework, guiding the attendees through the decision tree, toward the complete assessment and high-level design of a possible blockchain architecture for the selected use cases.

Such a tool, which will be the final outcome of the Working Group, and that will be further refined during the session and subsequent online iterations, will allow people from diverse backgrounds to interact fruitfully with blockchain developers, toward the creation of successful blockchain use cases in a variety of health-related data handling domains.

Meeting agenda: 

Collaborative session notes:


  • Brief introduction to the WG and work plan description
  • Presentation of the group’s second report on ‘legal and regulatory issues
  • Q&A
  • Presentation on ‘decision tree’ for blockchain solutions and discussion on participants’ use cases
  • Next steps (looking forward the conclusion of the WG activities and producing a set of comprehensive guidelines)
Target Audience: 

For this session, we invite Healthcare Data Scientists dealing with data licensing and patient privacy issues, distributed system experts, privacy and security researchers from informatics and computer science, Policy-makers for Healthcare, Health bioinformatics legal experts, Healthcare and Health Maintenance Organisation administrators, Clinicians (to use data technology to improve practice), Biomedical researchers (using analytical techniques), Pharmaceutical industry researchers and manufacturers, Medical equipment researchers and manufacturers, In silico modelling, testing and clinical trial experts and other interested professionals.

Participants are encouraged to present their specific use cases with regard to possible application of blockchain in their sector during the session.

For those who are interested in having a look at a first version of decision scheme, it is available in the Presentation held at P13 on State of the Art report:

Group chair serving as contact person: 
Brief introduction describing the activities and scope of the group: 

The Blockchain Applications in Health WG was promoted by the Health Data IG in order to focus on Blockchain in Health data, with special regard to the potential of such a system and whether the blockchain can ensure compliance with advanced data protection requirements (such as those defined, for instance, by the EU General Data Protection Regulation – GDPR), yet making it happen seamlessly and efficiently, at scale.

After two BoFs held at P9 in Barcelona and at P10 in Montreal, with rising interest in the RDA community, the WG was endorsed and had its first official meeting at P12 in Gaborone, while at P13 in Philadelphia the first goal described in the case statement – the “State of Art report” – was presented and discussed.

The next Plenary will be the occasion for further developing the outcomes of the meeting held at P13 and for addressing the second goal provided in the case statement, namely the report on legal regulatory issues.

The final goal of the WG (after 18 months) will be to provide a set of comprehensive guidelines  on Blockchain Applications in Health.

Short Group Status: 

Recognised & endorsed. At P14 the Blockchain Applications in Health WG will be running 12 months of activity and will be getting ready for its last 6 months, when the final deliverable is expected to be released.

Type of Meeting: 
Working meeting
Avoid conflict with the following group (1): 
Avoid conflict with the following group (2):