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ICT for Health: Networks, standards and innovation

the smart contract; nor supporting the execution environment corporations to use distributed ledgers to maintain their share
of that smart contract. The parties are identified with their ownership registry. Vermont (12 V.S.A. § 1913) explicitly
blockchain accounts and transactions record obligations identified blockchain records as being admissible as
fulfilled under the smart contract. Smart contracts can evidence in court. Wyoming (§17-206) exempts open
replace error-prone human judgements with specific rule- blockchain tokens from registration as securities in contrast
based actions capturing best practices and by automating with views from regulatory agencies like CFTC and SEC
workflows eliminate the need for acknowledgements by treating cryptocurrencies as securities or commodities.
healthcare professionals [42]. While healthcare data may not seem like a commodity or
security, healthcare blockchain advocates may need to care
Perhaps inspired by Barlow’s declaration of the whether emerging regulatory language is over-inclusive.
independence of cyberspace [43], the decentralized,
anonymous and autonomous nature of some early blockchain Much of the existing legal precedents are based on criminal
implementations lead to proponents of DAOs which behavior around blockchain 1.0 cryptocurrency/ fintech, but
purported to have the operating software of the blockchain the data underlying healthcare blockchains is not a fungible
be an independent legal entity. Other automated trading financial asset. Market participants involved in distributed
systems have made automated transactions on behalf of their ledger systems like blockchain also must keep in mind
account owners for some time, but here the software itself conduct-related legislation implementing public policy
was purported to be the account owner. The law has a history including Antitrust, data protection, copyright, property and
of recognizing fictitious entities (e.g. corporations). tax, but, in comparison with cryptocurrencies, these areas are
Ownerless corporations have been proposed almost 30 years not anticipated to be of particular concern for healthcare
ago [44] and the enabling acts of several states would seem blockchains.
to permit zero-member LLCs [45] though such entities
would raise a number of social and political concerns [46]. The recent European Union General Data Protection
An early implementation of a DAO based on bitcoin did not Regulation (GDPR) creates additional legal protections for
fare well [47]. Despite efforts to transition governmental personal information in general, and other jurisdictions may
services to electronic form, from service of process to be considering similar regulations. Blockchains operated
judgement enforcement a purely software entity would be within the scope of those regulations may need additional
difficult to interface with a human and paper-driven legal design features to meet the GDPR requirements [49].
system. Beyond general data privacy regulation, healthcare
blockchains and smart contracts would be impacted by
Distributed ledger technologies could be considered by healthcare specific regulations (e.g. HIPPA [50] which has
courts in several legal systems as joint ventures or obligations for data privacy in contrast with many
partnerships between participants [48]. If a partnership were blockchain implementations that rely on a publicly visible
determined to exist, then joint and several liability would blockchain).
extend to all the partners. Joint and several liability means
the plaintiffs can collect any damages award from any one of Consider a healthcare smart contract executing on a
a group of partners. The extent of the partnership would be blockchain accepting data from an oracle reporting on a
determined by the court given the facts and circumstances of physiological condition through a smart phone, making some
the case. analysis of the data and reporting exceptional health
conditions as an alarm to a healthcare professional. The
4.2 Public law definition of a medical device [51] is sufficiently broad that
this healthcare smart contract could be considered a medical
Because blockchain technology is relatively new, there is not device and subject to medical device regulation. An error in
yet a lot of blockchain specific laws and regulation in place, such a smart contract medical device could create product
and what there is has been driven by cryptocurrencies rather liabilities.
than healthcare blockchain applications. Blockchain related
legislation is under consideration in a number of 4.3 Private law
6
states .Arizona explicitly recognized electronic signatures
secured by blockchains as valid signatures and defined smart Private law differs in different legal systems, but generally
contracts secured through blockchains as valid electronic liabilities can arise through contracts, torts, partnerships or
records. A.R.S §44-7061 defines a smart contract as: “an specific legislation. Tort claims are particularly important
event-driven program, with state, that runs on a distributed, where there is no contractual liability. Joint tortfeasors are
decentralized, shared and replicated ledger and that can take two or more individuals with joint and several liability in tort
custody over and instruct transfer of assets on that ledger”. for the same injury to the same person or property. Whether
Delaware enacted legislation (D.C. §8-224) enabling healthcare smart contracts implemented on blockchain

6 http://www.ncsl.org/research/financial-services-and-commerce
/the-fundamentals-of-risk-management-and-insurance-viewed-
through-the-lens-of-emerging-technology-webinar.aspx.

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