Analysis of Legal and Regulatory Frameworks in Digital Health: A Comparison of Guidelines and Approaches in the European Union and United States

The advent of digital technology in healthcare presents opportunities for the improvement of healthcare systems around the world and the move towards value-based treatment. However, this move must be accompanied by strong legal and regulatory frameworks that will not only facilitate but encourage the good use of technology. The goal of the study was to assess the amenability and furtherance of regulatory frameworks in digital health by evaluating and comparing the processes, effectiveness and outcomes of these frameworks in the European Union and United States. Methods: This study incorporated two research methodologies. The first was a research of current legal and regulatory frameworks in digital health in the European Union and United States. A comprehensive online search for publications was carried out which included laws, regulations, policies, green papers, guidelines and recommendations. This research was complemented with interviews of five purposively sampled key informants in the legal and regulatory landscape. Results: Mind-maps revealed key features and challenges of the digital health field in the topics of the current state of regulation of digital health in the EU, Germany and US, regulatory pathways for digital health devices, protection and privacy of health data, mobile health validation, risk-based classification of medical devices, regulation of clinical decision support systems, telemedicine, artificial intelligence and emerging technologies, reimbursement for digital health services and liability for digital health products. The experts expressed and explained key points where current regulation is deficient. The review of the legal frameworks revealed deficiencies which provide opportunities and recommendations to further develop and strengthen the regulatory landscape. Conclusions: A key element to a robust regulatory framework is the ability to ensure trust and confidence in using digital health technology. Technology must measure the impact on quality of life and burden of disease and not merely involve the collection of data

Democracy and Digital Authoritarianism: An Assessment of the EU’s External Engagement in the Promotion and Protection of Internet Freedom. College of Europe EU Diplomacy Paper 01/2020

The past decade has seen a gradual global increase in digital authoritarianism. Internet shutdowns, online censorship, mass surveillance and violations of privacy rights have all become more frequent in parts of the world where citizens are not guaranteed sufficient digital rights. The task of defending, promoting and protecting internet freedom is becoming increasingly relevant for the European Union (EU) − for internal digital and cybersecurity policies as well as for the EU’s external promotion of democracy and human rights. Whilst much has been written about the various internal policies which establish and protect internet freedom within the European Union and its member states, the EU’s external engagement in this field remains critically under-researched. To what extent does the EU engage externally in the promotion and protection of internet freedom? This paper answers this question by covering a wide variety of policy fields including human rights and democracy promotion, digital policy, enlargement and neighbourhood policy, development cooperation and trade policy. Whereas the EU faces a limited opportunity to shape global norms with regard to internet freedom or to change the course of digitally authoritarian states, it has demonstrated several strengths which deserve not to be overlooked. These include, for example, the externalisation of internal data protection and policies and the provision of direct support and protection for civil society. Despite facing significant obstacles, the promotion and protection of internet freedom has become an important area of the EU’s external action which is only set to become more relevant in the coming years

Tackling food marketing to children in a digital world: trans-disciplinary perspectives. Children’s rights, evidence of impact, methodological challenges, regulatory options and policy implications for the WHO European Region

There is unequivocal evidence that childhood obesity is influenced by marketing of foods and non-alcoholic beverages high in saturated fat, salt and/or free sugars (HFSS), and a core recommendation of the WHO Commission on Ending Childhood Obesity is to reduce children’s exposure to all such marketing. As a result, WHO has called on Member States to introduce restrictions on marketing of HFSS foods to children, covering all media, including digital, and to close any regulatory loopholes. This publication provides up-to-date information on the marketing of foods and non-alcoholic beverages to children and the changes that have occurred in recent years, focusing in particular on the major shift to digital marketing. It examines trends in media use among children, marketing methods in the new digital media landscape and children’s engagement with such marketing. It also considers the impact on children and their ability to counter marketing as well as the implications for children’s rights and digital privacy. Finally the report discusses the policy implications and some of the recent policy action by WHO European Member States

U.S.-EU Safe Harbor Framework; A Guide to Self-Certification

[Excerpt] In this guide, we have provided an outline of the most critical pieces of the Safe Harbor Framework. The application is made available, along with a Helpful Hints Guide that explains how to fill it out. The Safe Harbor Principles and FAQs are also provided for easy reference. There is also an explanation and listing of third party dispute resolution providers (or Independent Resource Mechanisms) with descriptions of the services provided by three dispute resolution providers that work with Safe Harbor. Finally, we’ve also included several sample company privacy policies for reference, and a glossary that explains key terms. We’ve broken this Guide into nine major sections, each to address different questions you might have. What follows is a brief description of each section: Overview: The overview gives some background on the Safe Harbor Framework, how it came about, and explains many of the certification requirements. The overview also lists the principles of the Safe Harbor program. Application: The Application is provided for easy reference. Applicants should apply online at http://export.gov /safeharbor (click on “Certification Form” in the right sidebar). Certification Mark: The Commerce Department’s International Trade Administration has recently developed a certification mark for the Safe Harbor Framework. The mark may be used by companies on their websites to signify that they have self-certified compliance with the provisions of the Safe Harbor Framework. Instructions for use of the certification mark are provided. Helpful Hints Guide (to Certification): The Helpful Hints Guide is meant to give quick answers to any questions a U.S. company might have about the certification process. It should be used in conjunction with the rest of the Guide, however it answers many of the most common questions about the certification process. Safe Harbor Principles: We have provided the full text of the official declaration of the Safe Harbor Principles as announced on July 21, 2000. This text is helpful for understanding the foundation of the Safe Harbor Principles and the Framework. Frequently Asked Questions: We have provided the Frequently Asked Questions in full text because they answer many of the most commonly asked questions about the Safe Harbor Framework. Dispute Resolution Providers: Here we have provided a short description of the role of dispute resolution providers (also referred to as Independent Recourse Mechanisms) and descriptions of the services they offer. Sample Privacy Policies: Here we have provided three sample privacy policies for reference, which may serve as guidance when creating a new Privacy Policy or updating an existing Privacy Policy to align it with the Safe Harbor Framework. The Safe Harbor Framework requires an affirmative commitment in the Privacy Policy to the principles of the Safe Harbor Framework. Glossary: A short glossary is also provided for many of the technical terms frequently used in the Guide

E-Commerce and Trans-Atlantic Privacy

For almost a decade, the United States and Europe have anticipated a clash over the protection of personal information. Between the implementation in Europe of comprehensive legal protections pursuant to the directive on data protection and the continued reliance on industry self-regulation in the United States, trans-Atlantic privacy policies have been at odds with each other. The rapid growth in e-commerce is now sparking the long-anticipated trans-Atlantic privacy clash. This Article will first look at the context of American e-commerce and the disjuncture between citizens\u27 privacy and business practices. The Article will then turn to the international context and explore the adverse impact, on the status quo in the United States, of European data protection law as harmonized by Directive 95/46/EC of the European Parliament and of the Council of 24 Oct. 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Following this analysis, the Article will show that the “safe harbor” agreement between the United States Department of Commerce and the European Commission--designed to alleviate the threat of disruption in trans-Atlantic data flows and, in particular, to mollify concerns for the stability of online data transfers--is only a weak, seriously flawed solution for e-commerce. In the end, extra-legal technical measures and contractual mechanisms might minimize privacy conflicts for e-commerce transactions, but an international treaty is likely the only sustainable solution for long-term growth in trans-border commercial interchange

A children’s rights perspective on the responsibility of social network site providers

It is the aim of this paper to analyse this issue from a children’s right perspective and to identify a theoretical, broader basis that can be used by policymakers to persuade social network site providers to enhance their Corporate Social Responsibility efforts to provide young users with a communication and interaction platform that respects and helps realising their fundamental rights.status: publishe

Big Brother is Listening to You: Digital Eavesdropping in the Advertising Industry

In the Digital Age, information is more accessible than ever. Unfortunately, that accessibility has come at the expense of privacy. Now, more and more personal information is in the hands of corporations and governments, for uses not known to the average consumer. Although these entities have long been able to keep tabs on individuals, with the advent of virtual assistants and “always-listening” technologies, the ease by which a third party may extract information from a consumer has only increased. The stark reality is that lawmakers have left the American public behind. While other countries have enacted consumer privacy protections, the United States has no satisfactory legal framework in place to curb data collection by greedy businesses or to regulate how those companies may use and protect consumer data. This Article contemplates one use of that data: digital advertising. Inspired by stories of suspiciously well-targeted advertisements appearing on social media websites, this Article additionally questions whether companies have been honest about their collection of audio data. To address the potential harms consumers may suffer as a result of this deficient privacy protection, this Article proposes a framework wherein companies must acquire users\u27 consent and the government must ensure that businesses do not use consumer information for harmful purposes