AI use in healthcare. Processing of beneficial owners determination.

Maksym Baryshnikov

Short description:

Wide spread of the Artificial Intelligence (AI) use among technologies in the health care field raises the question of the legal settlement of the intellectual property rights that may arise during such a process. In particular, we are talking about new methods and methods of treatment and diagnosis of patients in the field of medical services, development of new chemical and biological compounds in the field of pharmaceuticals (industrial property), preparation of scientific and applied texts (copyright). All these issues require urgent positive solutions not only as theoretical achievements but also as a concrete rules in national and international law.

Key words: Beneficial owner, artificial intellect, medical and pharmaceutical law, intellectual property, information, patients, administrative law.



Studying of the ways and methods of legal regulation of Artificial Intelligence technologies in general and in the field of health care, in particular, are driven by the objective needs due to the rapid development and qualitative transformation of these technologies, which push their increasingly using in medical and pharmacological practice and research. It is not surprisingly that the first words of EU White Paper on Artificial Intelligence told us that Artificial Intelligence is developing fast. It will change our lives by improving healthcare (e.g., making diagnosis more precise, enabling better disease prevention) [1]. As an example from the Finnish national AI strategy artificial intelligence applications will allow a worker with a lower level of education to be able to perform jobs previously carried out by people with higher level education (eg, a nurse can use an app to carry out a doctor’s work). Especially, the public sector and health care will use this opportunity in an aggressive manner [2].

Exploring the nature of artificial intelligence, giving it the properties of a legal participant in relationships, legal personality no longer seems something unrealistic, but is a matter of agenda. Not coincidentally, the European Commission President-elect, Ursula von der Leyen, has announced that she will be moving forward with legislative proposals for a coordinated European approach to the human and ethical implications of AI within her first 100 days in office [3].

Today, researchers and practitioners are faced with the issue of regulating the numerous relationships that arise about the emergence of new intellectual property rights in the practical application of artificial intelligence technologies, including in computer diagnostic programs, medical work, in the activity of research centers in the pharmacological industry, preparation of medical articles, annotations, conclusions and other similar texts. Probably the first mentioned problems became the subject of research in the Final Report on the National Commission on New Technological Uses of Copyrighted Works (1978) and later in the 1981 report [4]. Judge Learned Hand opinion in widely recognized case Reiss v. National Quotation Bureau, Inc., 276 Fed. 717, 719 (S.D.N.Y. 1921) that is often cited in famous court rulings such as Google v. Oracle (2020) [5].

Problem + analysis:

In theory, the intellectual property rights that result from the use of artificial intelligence can belongs to one of three groups of entities, namely:

• developers of software complexes;

• owners (operators);

• users (companies or patients).

At the same time, the legal status of the authors of the primary sources of information and training for artificial intelligence emerges as a separate question.

The safety issue of the results of AI activity has long been not debatable and theoretical, a practical affirmative answer to it is no longer surprising or unacceptable. The debate over the term of copyright that preceded the adoption of Copyright Act 1710 (1709) (Queen Anne’s Statute) [6] has taken on new significance in relation to those resulting from the use of artificial intelligence.

Given the concept of beneficial owners, it is proposed to equate those with authors in the understanding of national rules and international conventions regarding the term of copyright. Similar administrative rules should be updated in the Berne Convention for the Protection of Literary and Artistic Works, in particular Article 2 § 6 and § 4. Article 5 where protection that would operate for the benefit of the author and his successors in title should be added with benefit owners and the country of origin should also be considered to be a country of beneficial owner incorporation. And in the p.p. 1, 3 of Article 7 the term “author life” should be added with “or beneficial owner activity in respect of AI works results”. All proposed changes may be incorporated in national legislation based on Article 19 that the entities that the provisions of this Convention should not preclude the making of a claim to the benefit of any greater protection that may be granted by legislation in a Union country [7].

The author proposes to address two related issues – copyright and industrial property rights. In both cases, it is proposed to introduce a new concept, namely “Beneficial owner”, which should become one of the three entities listed above and have all the rights of the author (inventor), including the following powers:

• The right to seek protection of rights;

• The right to authorize the use (exclusive or non-exclusive license);

• The right to protect (prohibit) the unlawful use of such intellectual property, including the procedural rights of the litigant.

Thus such rules in some aspects already exists in UK legislation according to CDPA,1988 9(3) in the case of a literary, dramatic, musical or artistic work which is computer-generated, the author shall be taken to be the person by whom the arrangements necessary for the creation of the work are undertaken [8].

Unlike this judge Jessup from Australian Federal court adjudicate that there is no a priori reason to deny a body of source code… It consists of words, letters, numbers and symbols which are intelligible to someone skilled in the relevant area, and which convey meaning. And then she noted that quite apart from the question whether the putative author was a “qualified person”, and allowing for the possibility, in some cases, of a work having multiple authors, as a general proposition the need for a work to spring from the original efforts of a single human author is a fundamental requirement of copyright law [9].  Recently other court find out completely different conclusion, a court in the Chinese city of Shenzen has decided that an article that was written by an artificial intelligence program has copyright protection. The article was written by Tancent’s Dreamwritee AI Writing Robot, an internal code at the Chinese tech giant [10].

It is cleat that the “Personal touch” approach is outdated and needs to be updated. The text of Universal Copyright Convention Article IV (2) that stated the term of protection for works protected under this Convention shall not be less than the life of the author and twenty-five years after his death[11] should be changed dramatically and in in the nearest future using beneficial owners conception.

In cases of AI using in healthcare we should provide maximum protection for patient (and all humans are potential or real patient), не дивно EU White paper визнає, що as with any new technology, the use of AI brings both opportunities and risks. Citizens fear being left powerless in defending their rights and safety when facing the information asymmetries of algorithmic decision-making, and companies are concerned by legal uncertainty. While AI can help protect citizens’ security and enable them to enjoy their fundamental rights, citizens also worry that AI can have unintended effects or even be used for malicious purposes. These concerns need to be addressed. Moreover, in addition to a lack of investment and skills, lack of trust is a main factor holding back a broader uptake of AI[2. p.8].

The situation with the introduction of a special subject- beneficial owner in relation to industrial property relations is much simpler since the provisions of Article 4, paragraph A-1, of the Paris Convention clearly define the right to any person who has duly filed an application for a patent, or for the registration of a utility model, or of an industrial design, or of a trademark, in one of the countries of the Union, or his successor in title, shall enjoy, for the purpose of filing in the other countries, a right of priority during the periods hereinafter.

Article 2 (1) of the Convention specify National treatment for nationals of countries of the Union as they (of any country of the Union) shall, as regards the protection of industrial property, enjoy in all the other countries of the Union the advantages that their respective laws now grant, or may hereafter grant, to nationals; all without prejudice to the rights specially provided for by this Convention. And in the same time they shall have the same protection as the latter, and the same legal remedy against any infringement of their rights, provided that the conditions and formalities imposed upon nationals are complied with [12].

Thus any national law based on international law in the field of intellectual property can independently decide in each case which of the three groups of legal entities should be a bona fide owner. It is intended to be one of them as defined in a proper law or convention, unless otherwise provided for in the relevant agreements to be concluded between the developers, customers and users of artificial intelligence software in the medical field, whether or not used. whether in pharmacology or medical practice, it is only a program, or combined with a specific robotic platform.


The implementation of such copyright decision will require significant changes in international conventions and national law, as they are built on the indiscriminate human factor in the sense of authorship, and as long as the debate on artificial intelligence is underway, as is the development of technology itself, the author’s proposed solution can regulate those relationships that already exist and need positive protection. In practice, the proposed approach raises a number of issues, including copyright. Currently, the existing national legislation of no country does not contain sufficient regulatory framework to regulate the use of artificial intelligence technologies in medicine. International legal instruments only address this problem in their own individual provisions, which creates a real lacuna in regulating one of the most promising areas for the development of health and information technology. Among the publications on the topic are the articles by W. Marchal S Willick, Oleh Zaiarnyi, Nicholson Price II, Mina Krzisnik, Anastasia Greenberg, A. Atabekov, O. Yastrebov, etc. One of the very first was Shortliffe with his  Computer-Based Medical Consultations in 1976[13]

An example of special legislation is the Law on the Road to Health in the 21st Century, adopted in December 2016, which provides for broad measures to finance modern health developments and provides the green light for the Food and Drug Administration (FDA) for research to consent to the use of the latest emerging technologies in health care.
In this regard, the report “Developing the FDA Rules of Conduct for Artificial Intelligence in E-Health Products” is very interesting. Especially comparing with the European Parliament resolution of 16 February 2017 # 2015/2103 (INL) “Civil law rules on robotics” with recommendations to the Commission on the Regulation of Civil Law on Robotics, the preamble of which links to the path of ideas and their implementation from Frankenstein to of the Prague Golem. On the whole, the Resolution contains the principles and basic ideas for settling new relations on the use of robotics, including with elements of artificial intelligence, in particular in medicine (medical works are even allocated in paragraph 33 in a separate group of the general classification)[14].

At the same time, the proposed amendments to the provisions on industrial property and copyright will not require any significant changes, but will lead to a lasting relationship. The way to this was developed in the works in particular Shortliffe, E.H. in the 70s of the 20th century [15] and continued the works of A. Zayarny [16] will increase the level of confidence of their subjects in the protection of their rights and give confidence in the commercial success of future scientific researches of artificial intelligence technologies in medical and pharmaceutical fields and practical application their results for the benefit of the patients, as defined in the EU White paper in such cases, where the outcome could not have been prevented or anticipated at the design phase, the risks will not stem from a flaw in the original design of the system but rather from the practical impacts of the correlations or patterns that the system identifies in a large dataset[1, p.12].


1. White paper On Artificial Intelligence – A European approach to excellence and trust.

 Brussels, 19.2.2020 COM(2020) 65 final. URL: (last accessed:12.04.2020).

2. Finland’s Age of Artificial Intelligence. Turning Finland into a leading country in the application of artificial intelligence Objective and recommendations for measures. Ministry of Economic Affairs and Employment, Helsinki 2017. URL: (last accessed:12.04.2020).

3. EU guidelines on ethics in artificial intelligence: Context and implementation. European Union, 2019.URL: (last accessed:12.04.2020).

4. Final Report on the National Commission on New Technological Uses of Copyrighted Works, July, 1978 (1978). URL:  (last accessed:10.04.2020).

5. Google LLC v. Oracle America Inc.(2020) URL: (last accessed:10.04.2020).

6. An Act for the Encouragement of Learning, by Vesting the Copies of Printed Books in the Authors or Purchasers of such Copies, During the Times therein mentioned (the Statute of Anne) 1710, 8 Anne, c.19 URL: (last accessed:12.04.2020).

7. Berne Convention for the Protection of Literary and Artistic Works of September 9, 1886. URL: (last accessed:12.04.2020).

8. UK, Copyright, Designs and Patents Act 1988. URL: (last accessed:10.04.2020).

9. Acohs Pty Ltd v Ucorp Pty Ltd [2010] FCA 577/ URL: (last accessed:10.04.2020).

10. Andres Guanamuz. Chinese court rules that AI article has copyright. January 22, 2020 URL: (last accessed:10.04.2020).

11. Universal Copyright Convention, with Appendix Declaration relating to Articles XVII and Resolution concerning Article XI 1952. URL: (last accessed:10.04.2020).

12. Paris Convention for the Protection of Industrial Property (as amended on September 28, 1979) (Official translation) URL: (last accessed:13.04.2020).

13. Max R. Baryshnikov The phenomenon of Artificial Intelligence and the meaning of its terminological definition for the legal regulation of its application in healthcare. 2020. URL: (last accessed:13.04.2020).

14. Developing the FDA Rules of Conduct for Artificial Intelligence in E-Health Products URL: (last accessed:14.04.2020).

15. Shortliffe, E.H. Computer-Based Medical Consultations: MYCIN, Elsevier/North Holland, New York, 1976. URL: (last accessed:13.04.2020).

16. Oleh Zaiarnyi Directions for improving the legal liability of medical organizations for artificial intelligence systems application. June 2018 Medicine and law 37(2):363-382