[Ip-health] WHO: Draft global strategy on digital health threatens data sovereignty

K.M. Gopakumar kumargopakm at gmail.com
Thu Feb 6 18:59:37 PST 2020


*TWN Info Service on Health Issues (Feb20/03) 6 February 2020 Third World

*WHO: Draft global strategy on digital health threatens data sovereignty*

Geneva 6 February (TWN) – WHO’s Draft Global Strategy on Digital Health (Draft
threatens the data sovereignty, including the right to regulate, of Member

The Draft Strategy is submitted for the consideration of the Executive
Board (EB) to recommend its adoption at the 73rd World Health Assembly
(WHA) in May 2020.

The 146th meeting of EB is currently taking place in Geneva at the WHO
headquarters from 3 to 8 February.

Output 3.1 under Strategic Objective 3 of  the Draft Strategy states:
exists, in accordance with Secretariat-led international health data
regulation, that enshrines health data as a global public health good and
outlines principles of equitable data-sharing and international digital
health and artificial intelligence research collaboration and partnerships*”.

Strategic Objective 3 is to strengthen governance for digital health at
global, regional and national levels. Thus Output 3.1 aims to put in place
a guiding principle of governance that treats health data as a public
health good, and outlines principles of access.

Though data sharing is important to achieve public health outcomes, the
conceptualisation of data as a global public health good results in
free-riding on data and undermines the right of Member States to regulate
the cross border transfer of data, its usage etc. Further, in the absence
of corresponding obligations to share the benefit arising from such data,
this vacuum would help technology companies to make use of the data for
commercial purposes, without any obligation on its accessibility and
affordability. To date there is no consensus among WHO Member States to
treat health data as a global public health good. Such a conceptualisation
would seriously undermine the sovereign right of a State to regulate the
data (including its use) and the community ownership of health data.

Health and public policy activist Nicoletta Dentico told Third World
Network that the Draft Strategy ignores the public ownership of data and
will lead to extreme (corporate) concentration.

The proposed outcome of equitable data sharing does not preclude the use
for commercial purposes. This goes against current WHO policy i.e Policy
use and sharing of data collected in Member States by the World Health
Organization (WHO) outside the context of public health emergencies.
This document clearly states: “*agrees that WHO shall be entitled, subject
always to measures to ensure the ethical and secure use of the data, and
subject always to an appropriate acknowledgement of the country: to publish
the data, stripped of any personal identifiers (such data without personal
identifiers being hereinafter referred to as “the Data”) and make the Data
available to any interested party on request (to the extent they have not,
or not yet, been published by WHO) on terms that allow non-commercial,
not-for-profit use of the Data for public health purposes (provided always
that publication of the Data shall remain under the control of WHO)*”.

Further, the proposed actions of Member States, the Secretariat and
partners in the short term, medium term and long term related to Strategic
Objective 3 is contained in the Annex of the Draft strategy. Member States
in the medium term are required to “*establish national data governance
mechanisms, in accordance with WHO International Health Data Regulation*”.

Partners in the short term are to “*Support the Secretariat in establishing
international health data regulation, a framework for regulating,
benchmarking or certifying artificial intelligence and digital health
medical devices*”. Interestingly, no action is proposed for the Secretariat
regarding the establishment of international health data regulation.  It is
also noteworthy that currently there is nothing called “WHO International
Health Data Regulation”.

Paragraph 61 of the Global Strategy states: “*The Secretariat will work
closely with Member States, other bodies in the United Nations system,
international partners and other stakeholders to implement the global
strategy. It is intended that various stakeholders will take the strategic
objectives forward at national, regional and global levels. These
stakeholders mainly include, but are not limited to intergovernmental and
international organizations; non-State actors such as nongovernmental and
civil society organizations, donors and aid agencies, foundations and
development banks; universities and research institutions; health insurance
groups and other health-care funders; the private sector and technology
developers; and the health-care community, patients and the public*”.

The proposal to take support from WHO partners, mainly the private sector
actors, to establish international data regulation goes against WHO’s
Framework of Engagements with Non-state Actors (FENSA). Principle 5(e) of
the FENSA states: “ *… protect WHO from any undue influence, in particular
on the processes in setting and applying policies, norms and standards*”.
The footnote to this paragraph elaborates on the principle: “*Policies,
norms and standard setting includes information gathering, preparation for,
elaboration of and the decision on the normative text*”.

Thus taking regulatory development support not only from the private sector
but also from other non-State actors is prohibited. Further, the
engagements with the private sector in norms and standard-setting processes
raise concerns of conflict of interest. FENSA’s private sector policy
states that financial and in-kind contributions from the  private sector
should not be used for normative work.

The Draft Strategy is silent on FENSA and safeguards on conflict of

Another worrying statement in the Draft Strategy is its advocacy for
multistaekholderism. Strategic  Objective 1 on promoting global
collaboration and advance the transfer of knowledge on digital health
proposes: “*Multistakeholder groups are convened on a regular basis to
support digital health and innovation scale-up to accelerate health-related
Sustainable Development Goals*”. SDG 17 mentions “partnerships” and not
multistakeholder groups. The multi-stakeholder framework treats the
government and non-governmental actors on an equal footing and bears the
risk of regulatory capture and undermining of public health aspects of
digital health.

The Draft Strategy is prepared in accordance with Resolution WHA 71.7,
which requested the WHO Director-General “*to develop, within existing
resources, and in close consultation with the Member States, and with
inputs from relevant stakeholders as appropriate, a global strategy on
digital health, identifying priority areas including where WHO should focus
its efforts*”.

However, Resolution WHA 71.7 clearly recognises the right of Member States
to regulate the data. The resolution urged the Member States “*to develop,
as appropriate, legislation and/or data protection policies around issues
such as data access, sharing, consent, security, privacy, interoperability
and inclusivity consistent with international human rights obligations, and
to communicate these on a voluntary basis to WHO*”.

Further, regarding norms and standard-setting, Resolution WHA 71.7 requests
the DG “*to ensure that WHO builds on its strengths, by developing guidance
for digital health, including, but not limited to, health data protection
and usage, on the basis of its existing guidelines and successful examples
from global, regional and national programs, including through the
identification and promotion of best practices, such as evidence-based
digital health interventions and standards*”.

The Draft Strategy ignores this guidance and considers data as a global
public good without any discussion with the Member States and undermines
the community ownership and national sovereignty over data.+

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