Digital Health Legal

Volume: 3 Issue: 4
(April 2016)


The World Health Organisation (‘WHO’) published on 14 March its report ‘From innovation to implementation - e-Health in the WHO European Region,’ based on data collected from the 2015 WHO global survey on eHealth. The report outlines key trends and progress in eHealth across Europe, highlighting an ‘increasing appetite for eHealth.’ Further, the report makes law and policy recommendations to expand the use of eHealth. / read more

Singapore’s National Healthcare Group (‘NHG’), Serious Games Association and Infocomm Development Authority launched the Health Innovation Technology Challenge (‘HITC’) on 28 March, a nationwide contest for game technologies and gamification solutions that help identify healthcare problems and provide innovative healthcare solutions. / read more

Thailand’s health system suffered a data breach in late March, which saw the personal details of foreign nationals living in Thailand leaked online, an official from the Department of Disease Control at the Ministry of Public Health, has confirmed. The cause of the breach, according to the Ministry, was due to a security weakness that allowed health officials to access the database of personal health information without logging-in and the transfer of that data to other health officials, resulting in an unintentional leak of data. / read more


Whilst initially focused on financial services, blockchain technology holds much promise for addressing challenges in healthcare such as interoperability. Mike Gault, CEO of Guardtime, a provider of cyber security products and solutions that utilise blockchain technology, reviews how the technology works and its specific applications in healthcare. / read more

Sweden’s government has set the country a target: to be the world leader in eHealth by 2025. Pontus Sörlin, Partner at Gärde Wesslau, explains some of the current challenges for Swedish eHealth, and takes a detailed look at the Swedish government’s most recent report on eHealth, which inter alia recommends the setting up of a new national medical registry to be run by the Swedish eHealth Agency. The report, and particularly this suggestion, has drawn plenty of criticism however, as Pontus explains. / read more

The US Department of Health and Human Services Office for Civil Rights (‘OCR’), which monitors Health Insurance Portability and Accountability Act 1996 (‘HIPAA’) violations, plays a crucial role in monitoring mHealth apps used by healthcare providers. Recently the OCR issued guidance for mHealth app developers, which is intended to assist those developers in determining the applicability of HIPAA to them. Sheryl Tatar Dacso, Partner at Seyfarth Shaw LLP, and member of the eHealth Law & Policy editorial board, discusses the context and details of the OCR’s guidance. / read more

In February 2014 Italy implemented the EU Falsified Medicine Directive, which obliges Member States to regulate the sale of over-the-counter (‘OTC’) medicines via information society services. However, the regulation around the online sale of OTC medicines in Italy was not completed until earlier this year, when a Circular issued by the Italian Ministry of Health established instructions for such online sales. Davide Bresner of Portolano Cavallo explains the conditions under which OTC medicines can be sold online in Italy and the requirements for retailers wishing to do so. / read more

On 5 January 2016, the Federal Trade Commission (‘FTC’) announced that Henry Schein Practice Solutions, Inc. (‘Schein’) would pay $250,000 to settle the FTC’s charge for falsely advertising that Schein’s Dentrix G5 software enabled dentists to meet the Health Insurance Portability and Accountability Act 1996 (‘HIPAA’) encryption requirements. / read more

Apple announced on 21 March the introduction of its CareKit product, a software framework designed to enable developers to create apps to allow individuals to actively manage their own health conditions. CareKit follows the introduction of the medical research-oriented ResearchKit by Apple last year. Simon Fuller of eHealth Law & Policy spoke to Jodi Daniel, Partner at Crowell & Moring, about CareKit and its legal implications. / read more

In the very recent past two German hospitals were attacked by ransomware, a type of computer malware. The intrusions form part of a wider trend, which has also seen hospitals in the US hit by such cyber attacks. In light of these attacks, Marc L. Holtorf, Partner at Pinsent Masons Germany LLP, presents a brief review of the cyber security requirements German hospitals are facing. / read more

About Digital Health Legal:

Digital Health Legal is the monthly publication covering legal and regulatory issues and providing industry perspectives in the health IT sector. The publication covers eHealth, mHealth apps, data protection and privacy, electronic patient records, health data security and data breaches, telehealth and telemedicine, medical devices, online pharmacies, social media, standardisation, pharmacovigilance, patient safety, Big Data, health care informatics, cloud services in healthcare, liability, IP rights and HIPAA... /read more

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