Digital Health Legal

Volume: 2 Issue: 2
(February 2015)


The European Medicines Agency (EMA) launched a public consultation on 21 January into how transparency rules contained within the EU Clinical Trial Regulation will be applied to the new clinical trial database. / read more

A US House of Representatives panel published on 27 January the 21st Century Cures Act, a discussion draft containing proposals to accelerate the approval of medical drugs and devices; the document is the result of an initiative of the House Energy and Commerce Committee. / read more

The European Medicines Agency (EMA) has published a guide to support the implementation of a new international standard for the safety monitoring of medicines in the EU. The so-called ISO ICSR standard aims to establish a format for the reporting on individual cases of suspected side effects in patients due to a medicine around the globe. / read more


The European Commission (‘EC’) published a Summary Report on its Green Paper consultation on mobile health (‘mHealth’) on 12 January, which provides an overview of the responses from stakeholders to issues related to the uptake of mHealth in Europe. Alexander Csaki, Adriano Ros, Emma Drake and Clarissa Junge-Gierse of Bird & Bird assess the responses in brief and further consider the questions of interoperability, data protection and reimbursement in the context of mHealth adoption in Europe. / read more

Dr. Christian B. Fulda, Partner at Jones Day, provides his views on the EMA’s push for the public disclosure of clinical data in the context of the current consultation on the transparency requirements of the Clinical Trial Regulation. / read more

The US Food and Drug Administration (‘FDA’) released on 20 January its General Wellness: Policy for Low Risk Devices: Draft Guidance for Industry and Food and Drug Administration Staff (‘GW Guidance’). This document represents a new approach for the FDA in regard to general wellness products, as the FDA will refrain from enforcement of regulatory requirements on such products. The guidance is of particular note for the mobile health (‘mHealth’) industry, as Yarmela Pavlovic and Blake Wilson of Hogan Lovells explain. / read more

Craig Wentworth, Principal Analyst at MWD Advisors - a specialist advisory firm providing practical, independent industry insights to businesses working to drive change with the help of digital technology - explains how healthcare insurance is being transformed by technology and personal sensor data analytics, drawing comparisons between the motor insurance industry’s use of telematics with the potential development of pay-how-you-live healthcare policies. / read more

Sheryl Tatar Dacso, Partner, and John P. Tomaszewski, Senior Counsel, at Seyfarth Shaw LLP discuss the privacy and security laws proposed by US President Obama against the background of a number of security incidents affecting sensitive health data. / read more

Digital health, a category that was virtually non-existent five years ago, has exploded in recent years and shows the potential to remake the way healthcare is delivered worldwide. By Stephen Graham, Partner at Fenwick & West. / read more

Wearable devices can make the eHealth dream a reality at last, but they also exacerbate privacy concerns. Ezra Steinhardt of Covington & Burling LLP analyses the potential for wearables to deliver eHealth at scale, as well as the challenges they create. / 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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