key: cord-0958204-4vd4055k
authors: Kyhlstedt, Mattias; Andersson, Sarah Wamala
title: Diagnostic and digital solutions to address the COVID-19 pandemic: The need for international collaboration to close the gap
date: 2020-04-25
journal: Health Policy Technol
DOI: 10.1016/j.hlpt.2020.04.010
sha: 130feddfd7398d229be10e24901f40da227927d1
doc_id: 958204
cord_uid: 4vd4055k

nan

With this editorial, we aim to introduce a European initiative, COVID-19 Horizon Scanning, highlighting the importance of evidence through expert collaborations to support regulatory processes. Our initiative is organized in various work packages that include; access to reliable diagnostic tests and use of digital solutions to manage and to prevent the COVID-19 pandemic. We are facilitating this initiative while working across various academic disciplines, industries, consultants, HTA organizations and governments, for the greater good ( Figure 1 ). Even though the project has a European focus in this initial phase, the results are of relevance for a broader audience in other regions around the world.

In a situation where the demand for health-related actions may be determined by a tweet or what the media is pushing, the health technology assessment (HTA) scientific methods could potentially be overseen. This may likely jeopardize the regulated processes that ensure efficiency, safety, equitable access and effectiveness of new drugs and technology. In the current stage of the pandemic, it is crucial to control the spread of the COVID-19 and to optimize management and treatment of affected patients where a large proportion of those infected having mild symptoms which can be effectively managed at home. Thus, disease management tools (DMT) are crucial, and the impact of a DMT will depend on both the individual and organizational responses.

From our on-going review of national methodologies by HTA's to evaluate DHS in Europe, we were only able to find a few dedicated methodologies to demonstrate the value and effectiveness of digital health technologies (DHT) to guide developers and decision makers, where the "Evidence standards framework for digital health technologies" (2) by National Institute for Health and Care Excellence (NICE) in the United Kingdom is the most developed . For the DHS and DHT, the traditional HTA frameworks which focus on a specific clinical pathway are not enough. This is because other aspects such as, acceptance by the user, IT-security, scalability, and the ability to demonstrate effectiveness in a specific context become more relevant. The standard also identifies specific aspects regarding IT-security, to ensure a safe function, which is assumed to be covered within the European CE-marking approval processa prerequisite before a technology is placed on the market. One of the substantial limitations of the current Medical Device Directive (3), include allowing many types of DHS to be placed on the market without any review by an external body. This raises potential risks and concerns which should be evaluated prior to deployment of such solutions. The EUnetHTA makes an important distinction regarding diagnostics in their HTA-core model for evaluation of diagnostic tests (4). They highlight the need to understand the role of a technology in the entire healthcare pathway. They also provide guidance in evaluating what type of regulatory approval the product has. However, they do not include validity consideration. In our recent webinar (5) experts reviewed the extent of validity of the CE-mark in ensuring safe and effective tests in a broader perspective. Similar to the DHS, professional diagnostic tools, under the current Invitro Diagnostic Directive, do not require the evaluation of an external party before they can be CE-marked and placed on the market (6) . Even though the WHO Director General has a simple message to all countries "test, test, test" (7), the expert group identified the importance of developing guidance based on evidence, intention and specific performance requirements. In fact, a proper evaluation of a diagnostic test in this category -according to the new In Vitro Diagnostic Regulation (8), would require a review of an external notified body and a European expert panel, which may take up to a year. Yet, in the current situation we are experiencing use of products, whose development may have lasted for at most two or three months. For example, in Spain the government had acquired test kits with an "accurate detection rate of just 30%." (9) . In Sweden the Medical Product Agency has prohibited the use of two selfadministered tests for COVID-19 (10) which had not been reviewed by a notified body.

In our on-going review of digital solutions, we have identified more than 300 diagnostic tests for infection or immunity and more than 50 digital solutions directly related to COVID-19. These diagnostic solutions vary from Apps for self-tracking of symptoms to more advanced solutions, such as GEO-tracking (11) to track infected or diagnosed patients. Although, the GEO-tagging may easily be scaled-up to trace infected individuals remotely, to prevent the spread of the virus and avoid the risk exposure of vulnerable patient groups, they also raise crucial ethical issues.

Much as the virus has created unexpected chaos and panic in health systems all over the world, it is obvious that we need an immediate digital revolution not only to manage this crisis (12) , but also to shift mindsets and speed up the uptake of digital solutions in health and social care systems. We believe that this is a turning point for digital solutions to become an integral part of health and social care systems. Accordingly, there is a substantial need of methodological frameworks to ensure that this integration becomes not only successful but also safe, effective, efficient and money saving. The Covid-19 challenge highlights the need for preparedness of health systems to respond urgently, without losing focus on evidence frameworks and regulatory processes.

We believe that through collaborative efforts of various experts across Europe and other regions, we can contribute to evidence-based solutions that ensure safety, efficiency and effectiveness, while saving lives and minimizing waste and panic. This way we can adequately support regulatory bodies to make the right decisions regarding health policy, guidelines and use limited resources more wisely.

In this critical space of time, we attempt to introduce essential topics to support these rapid digital deployments, while collaborating with several international experts to support informed decision-making on diagnostic and digital solutions. We aim at understanding the needs and disseminating guidance on solutions that can make a difference for all. In the initial phase the focus is to get experts together to share experience and to shape the agenda for how different efforts and initiatives can move towards being evidence driven. This way, we can jointly close the gap between availability and access to safe and effective solutions, supported by evidence and best practice. For this purpose, we are seeking for a broad engagement from experts and organizations across boundaries for the greater good of ensuring access to the most effective digital solutions to address COVID-19. Will you join us?

COVID-19) -events as they happen

Evidence standards framework for digital health technologies | Our programmes | What we do | About

What is the value of CE-mark and other regulatory approvals when assessing diagnostic tests? | COVID-19 horison scanning

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

WHO Director-General's opening remarks at the media briefing on COVID-19 -16

/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance

Coronavirus test kits withdrawn in Spain over poor accuracy rate. The Guardian

Läkemedelsverket förbjuder två självtester för covid-19 | Läkemedelsverket / Swedish Medical Products Agency

Official information about COVID-19 in Iceland

Covid-19 and Health Care's Digital Revolution