Digital Health Legal

Volume: 4 Issue: 5
(May 2017)


The Article 29 Working Party (‘WP29’) published on 28 April 2017 its feedback on the draft mHealth Code of Conduct for Privacy (the ‘Code’) submitted in June 2016 by the Working Group created by the European Commission. The WP29 assessed the Code in regards to both the current EU Data Protection Directive (‘DPD’) and the requirements of the General Data Protection Regulation (‘GDPR’), and specifies a number of areas for improvement for the draft Code: inter alia that the draft Code does not provide sufficient added value to the DPD, and that the draft Code must go further in elaborating on the relationship between the DPD and Member States’ national legislation that implements the DPD. / read more

A number of NHS organisations were affected by the international ransomware attack that occurred on 12 May 2017, which wreaked havoc on IT systems around the world, reportedly resulting in cancelled operations and delayed treatment. WannaCry, ransomware targeting the Microsoft Windows operating system, has been described by Europol as an attack of an unprecedented scale.  / read more

The FDA’s new Digital Health Unit, which will sit within the Center for Devices and Radiological Health, will be established on 1 October 2017, confirmed Associate Center Director of the FDA Bakul Patel at a Medcon conference in Ohio on 4 May 2017. The FDA originally announced its intention to create a Digital Health Unit in the ‘MDUFA Performance Goals and Procedures, Fiscal Years 2018 Through 2022,’ published in February 2016, which explains that the Unit is being set up to ‘promote a culture of quality and organizational excellence’ by improving review consistency of Software as a Medical Device (‘SaMD’) and Software inside of Medical Devices (‘SiMD’), whilst also collecting and analysing results of digital health premarket submissions. / read more


The CNIL’s recommendations for passwords: a hindrance to the development of eHealth? The National Commission on Informatics and Liberty (‘CNIL’) in France has recently set out new guidelines for passwords to ensure digital health companies are adequately maintaining the protection of data and communications. Pierre Desmarais, Lawyer at Desmarais Advocats, shares his opinion on the guidelines and considers the potential adverse effect these guidelines could have on the development of the digital health industry. / read more

Australia has recently made changes to its Privacy Act to implement mandatory notification obligations in the event of an ‘eligible data breach,’ which require organisations suffering such a breach to notify certain authorities, subject to specific exemptions. These mandatory notification obligations become effective by 22 February 2018 and will affect healthcare providers, both private and public. Alec Christie and Sareena Oberoi of EY Law detail what healthcare providers need to know about the new obligations.  / read more

The European Medicines Agency (‘EMA’) in April this year updated its guidance on the implementation of its policy on the publication of clinical data for medicinal products for human use - Policy 70 - following the issuance of the original guidance in March 2016. The April 2017 revisions include a focus on the scope of Policy 70 and the anonymisation of data, and provide an update to certain templates. Here, Dr Christian B. Fulda, Partner at Jones Day, reviews the updated guidance and analyses how the contentious Policy 70 has in substance been amended, and expanded. / read more

Manuel Alonso, Partner at Jausas, reviews in this article recent trends in the mHealth app market, and assesses the reasons behind these developments. Manuel then goes on to focus on mHealth in Spain, reporting on local initiatives to promote mHealth, and explains the legal framework and related initiatives at an EU level that apply. Finally, Manuel provides a number of recommendations for developers in regard to keeping their mHealth apps compliant. / read more

The internet, combined with growing technology capabilities, offers unprecedented access to information, products, and services. At the same time, it makes possible new forms of communication and practices for attorneys that create ethical and legal challenges related to privileged communications, solicitation and security of confidential and privileged client information - including protected health information. In this article, Sheryl Tatar Dacso, Partner at Seyfarth Shaw LLP, focuses on the healthcare attorney’s role and responsibilities when dealing with a rapidly changing digital world. / 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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