Artificial intelligence in healthcare: medical, legal and ethical challenges ahead
Recommendation 2185
(2020)
- Author(s):
- Parliamentary Assembly
- Origin
- Text
adopted by the Standing Committee, acting on behalf of
the Assembly, on 22 October 2020 (see Doc. 15154, report of the Committee on Social Affairs, Health and
Sustainable Development, rapporteur: Ms Selin Sayek Böke).
1. Good health is a precondition for
more fulfilling individual lives and the progress of society as
a whole. Artificial intelligence (AI) is the latest technological
innovation to rapidly impact healthcare. Like many technological
innovations in healthcare, it harbours considerable potential for
improving both individual and public health, but also presents risks
for individual rights and public health. Furthermore, the speed
of the development and deployment of these technological advances
is much faster than that of the legal framework regulating them,
which requires close attention by policy makers and politicians.
2. AI applications in healthcare represent the paradigm shift
that is taking place in healthcare generally, by moving the focus
away from disease and therapy towards self-managed health, well-being
and prevention, and away from “one-size-fits-all” treatment protocols
to precision medicine tailored to the individual. In this changing environment,
full respect for human rights, including social rights, needs to
underpin public policy making for healthcare and guide further technological
progress. This is required to ensure that more mature AI mechanisms
can be deployed safely from a human rights perspective, and that
benefits from innovation are spread fairly and equitably across
society.
3. The Parliamentary Assembly notes that the scientific community
has urged public debate on the implications of AI applications in
healthcare and has highlighted the need for all stakeholders to
be more accountable. Policy makers, including parliamentarians,
at national, European and international levels must better understand
the wide-ranging risks, socio-economic impacts and opportunities
inherent in the design, development and deployment of AI technologies
in healthcare, so that they can seek pragmatic improvements and
propose adequate regulatory options that ensure full respect for
human dignity and rights through legal and ethical frameworks –
as far as possible with a global reach. This requires a collaborative,
multidisciplinary approach to defining AI-related risks and challenges
in healthcare.
4. The Covid-19 outbreak has focused attention on the role that
AI can play through real-time surveillance, assessment and management
of data on disease. It has also revived the much-needed debate on acknowledging
the right to health as a fundamental human right, which should be
secured through legal instruments and appropriate healthcare systems
that are publicly provided and that ensure universal access.
5. The Assembly heeds with concern the warning from the World
Health Organization (WHO) that the existing digital divide and inequalities
(within and between countries, as well as societal groups), coupled
with the spread of AI, might exacerbate the unequal distribution
of healthcare and problems of effective access to healthcare, reduce
the number and skills of health professionals, accentuate bias and
increase “disrespectful clinical interactions”, thus de facto worsening healthcare inequalities
and outcomes. The Assembly underlines that there is a broad global
consensus around the essential ethical principles of AI. It strongly
supports the work of WHO on developing ethics guidance on AI in
healthcare on the basis of the shared perspectives of various stakeholders,
including the Council of Europe and its Parliamentary Assembly.
6. Given that to date the private sector has driven most of the
research and development of AI applications for healthcare, national
public healthcare authorities should adopt a strategic approach
to co-ordinating digitalisation policies, research and investment,
as well as management and exploitation of personal data, with a
view to ensuring full protection of fundamental rights and striking
a healthy balance between individual, business and public interests.
In this context, the Assembly reaffirms its call, in
Recommendation 2166 (2019) “Human
rights and business – what follow-up to Committee of Ministers Recommendation
CM/Rec(2016)3?” to reflect on modern challenges and member States’
obligations under the European Social Charter (ETS Nos. 35 and 163),
including the right to health.
7. The Assembly stresses the pertinence of existing Council of
Europe legal instruments, in particular the European Convention
on Human Rights (ETS No. 5), the Convention on Human Rights and
Biomedicine (ETS No. 164, “Oviedo Convention”) and the Convention
for the Protection of Individuals with regard to Automatic Processing
of Personal Data (ETS No. 108) and its amending protocol (CETS No.
223, “Convention 108+”) in relation to AI-driven transformations
in healthcare. However, it believes that the scope and depth of
these transformations and the undeniable impact of AI technology
on human dignity and fundamental rights are such that the Council
of Europe, as the guardian of human rights, should prepare a dedicated
legal instrument on AI. It thus strongly supports the work of the
Ad hoc Committee on Artificial Intelligence (CAHAI) towards preparing
such a dedicated legal instrument.
8. The Assembly notes that privacy, confidentiality of personal
data and informed consent are the cornerstones of patient rights
worldwide. At the same time, certain restrictions on the use of
personal health data may disable essential data linkages and induce
distortions, even errors, in AI-driven analysis. It is debatable
whether the anonymisation or pseudonymisation of personal health
data are appropriate solutions.
9. The Assembly welcomes the intention of the Council of Europe
Committee on Bioethics (DH-BIO) to work on trust, safety and transparency
in the application of AI in healthcare. The Assembly encourages
it to take a comprehensive approach, to proceed with this work as
a matter of priority and to seek synergies with other Council of
Europe bodies working in this field.
10. Moreover, the Assembly considers that cybersafety requirements
for AI-enabled medical devices (including implantable and wearable
healthcare products) should be further explored in the framework
of the Convention on Cybercrime (CETS No.185), whereas the Committee
of Experts on Human Rights Dimensions of Automated Data Processing
and Different Forms of Artificial Intelligence (MSI-AUT) could complement
DH-BIO work by helping to define the liability of stakeholders –
from developers to regulatory authorities, intermediaries and users
(including public authorities, healthcare professionals, patients
and the general public) – with regard to the development, maintenance
and use of medical AI applications, and any damage caused by them.
11. The Assembly therefore recommends that the Committee of Ministers:
11.1 instruct the CAHAI to prepare
a dedicated legal instrument on AI, preferably a binding instrument with
a global reach, such as a convention open to non-member States,
with an emphasis on the human rights implications of AI in general
and on the right to health in particular;
11.2 involve other relevant Council of Europe bodies in CAHAI
work with a view to adequately covering health-related challenges,
notably in terms of privacy, confidentiality and cybersafety of
sensitive personal health data, informed consent and liability of
stakeholders;
11.3 mandate the DH-BIO and the Consultative Committee of the
Convention for the Protection of Individuals with regard to Automatic
Processing of Personal Data to seek synergies in their work towards guiding
member States on good governance of health data, with a view to
preventing any sovereign or commercial misuse of personal data through
medical AI applications;
11.4 update Recommendation CM/Rec(2016)3 on human rights and
business in order to reflect modern challenges and member States’
obligations under the European Social Charter (including the right
to health).
12. The Assembly furthermore recommends that the Committee of
Ministers encourage member States to:
12.1 build a holistic national approach, involving national
parliaments, to the use of AI technology in healthcare services
based on multistakeholder involvement and accountability, as well
as adequate evaluation of socio-economic and human rights impacts,
with a view to consolidating their population’s full access to public
healthcare services and giving effect to everyone’s right to health
as set out in the European Social Charter;
12.2 participate more actively in the development and deployment
of AI applications for healthcare services at national level and
provide for sovereign evaluation and screening of such applications
by independent institutions, as well as an exhaustive authorisation
process for their deployment, in particular in public health services,
to counter risks to individual rights and public health, in accordance with
the precautionary principle;
12.3 examine legal and technical options for certification
and validation of both publicly and commercially developed AI applications
for health (covering the end product and every stage of the AI design
process) at both national and European levels;
12.4 strengthen their national human rights impact assessment
framework for all health-related AI applications;
12.5 guarantee that AI-driven health applications do not replace
human judgment completely and that AI-enabled decisions in professional
healthcare are always validated by adequately trained health professionals;
12.6 elaborate a legal framework for clarifying the liability
of stakeholders for the design, deployment, maintenance and use
of health-related AI applications (including implantable and wearable
medical devices) in the national and pan-European contexts, redefine
stakeholder responsibility for risks and harm from such applications
and ensure that governance structures and law-enforcement mechanisms are
in place to guarantee the implementation of this legal framework;
12.7 discuss how to balance the requirement of strong protection
of personal data and the need to use certain types of personal health
data for the public good in the context of AI-powered enhancements
in public health, while respecting human rights, including as regards
the better preparedness of governance structures to anticipate and
manage the pandemic response;
12.8 accelerate their accession, if they have not yet done
so, to the Oviedo Convention and its protocols and to the Protocol
amending the Convention for the Protection of Individuals with regard
to Automatic Processing of Personal Data;
12.9 adapt their education and training systems to integrate
AI literacy into the curricula of schools and medical training institutions,
with an emphasis on the ethical principles of AI and responsible
uses of AI applications;
12.10 enhance investments in building the necessary digital
infrastructure to overcome the prevailing digital divide and to
ensure that AI-driven innovations do not exacerbate existing health
inequalities;
12.11 engage a national debate on AI for health in order to
raise the population’s and health professionals’ awareness of both
the risks and the benefits inherent in the use of AI applications
for wellness and healthcare, in particular with regard to certain
commercially developed applications already on the market which
take advantage of current legal voids;
12.12 consider options for harmonising the interconnectivity
of national health data networks and databases so as to enable human
rights compliant data linkages for AI-powered analysis and build “learning
health systems”.
