Info Service on Health Issues (Feb20/03)
WHO: Draft global strategy on digital health threatens data sovereignty
Geneva 6 February (TWN) – WHO's Draft Global Strategy on Digital Health (Draft Strategy) threatens the data sovereignty, including the right to regulate, of Member States.
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: "Governance 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 the 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 acknowledgment 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 the 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 non-governmental 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 process 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 interest.
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 programmes, 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.+