Digital Health Legal

Volume: 1 Issue: 3
(April 2014)


The European Commission (EC) launched a consultation on its Green Paper on mobile Health (mHealth) on 10 April, which seeks views from across healthcare on the barriers and issues related to mHealth. / read more

The US Food and Drug Administration (FDA), the Office of the National Coordinator for Health IT and the Federal Communications Commission published on 3 April their ‘FDASIA Health IT Report’ to Congress, mandated by the FDA Safety and Innovation Act (FDASIA) 2012; the Report proposes that the FDA will not extend its regulation of health IT. / read more

Simon Hughes MP, Minister of State for Justice and Civil Liberties, announced at the Data Protection Practitioner Conference, hosted by the UK’s Information Commissioner’s Office (ICO) on 3 March, that the Ministry of Justice plans to introduce legislation to extend the ICO’s powers of compulsory audit to NHS bodies. / read more


Former Senator Thomas A. Daschle (D-SD), Senior Policy Adviser at DLA Piper, LLP (US), co-leads the Alliance for Connected Care with former Senator Trent Lott (R-MS), Senior Counsel at Patton Boggs LLP, and former Senator John Breaux (D-LA), Senior Counsel at Patton Boggs LLP. Senator Daschle explains the importance of Connected Care for improved and more cost-effective care, the legal and regulatory barriers to innovation and the aims of the Alliance for Connected Care, a nonprofit organisation that was formed to create a statutory and regulatory environment in which every provider in the US is able to deliver and be reimbursed for safe, high quality care using Connected Care technologies, regardless of the type of technology and location of the patient. Members of the Alliance include Verizon, WellPoint, CVS Caremark, Walgreens, Teladoc, HealthSpot, Specialists On Call, Doctor on Demand, Welch Allyn, MDLIVE, Care Innovations, Cardinal Health, and GlobalMed. / read more

Matthew Godfrey-Faussett and Helen Austin of Pinsent Masons LLP present a snapshot of how developers of medical and health-related apps can gain access to the lucrative EU market, and how they can ensure compliance with regulations once they get there. / read more

Recently revised EU pharmacovigilance rules aim at collecting all possible relevant information concerning adverse reactions to medicinal products by strengthening the obligations on marketing authorisation holders and competent regulatory authorities. Numerous initiatives have been launched recently both in Europe and in the US to construe an efficient and reliable medicines surveillance system. Vincenzo Salvatore, Senior Counsel at Sidley Austin LLP and former head of the legal service at the European Medicines Agency, explains why only an integrated communication system, including eHealth patient records, will make marketing surveillance fully comprehensive and efficient. / read more

Mention Bring Your Own Device (‘BYOD’) and the Internet of Things (‘IoT’) to a hospital CIO and you’ll be greeted with a tired, almost defeated look that speaks volumes about the headaches created by trying to find a secure way for healthcare data to keep up with the times. These trends are not new, but with hospitals still trying to figure out how to navigate the security concerns that come hand in hand, it begs a closer look at the core issues and needs. By Dr. Andrew Litt, Chief Medical Officer at Dell. / read more

One of the most significant eHealth developments that Singapore has undertaken in recent years is the construction of the National Electronic Health Records (‘NEHR’) system. In line with the vision for ‘One Singapore, One Health Record,’ the NEHR system aims to establish an integrated health record system, allowing patients to move seamlessly across healthcare establishments in the country. In this article, Benjamin Gaw and Shawn Ting of Drew & Napier LLC provide an overview of the NEHR system. / read more

In recent years, Africa has demonstrated a strong and genuine will to supplement its lack of infrastructures via the massive development of telecommunications infrastructures. Africa has been in perpetual evolution with the implementation of more and more infrastructures and powerful networks, such as the ACE (African Coast to Europe) submarine communications cable, which allows broadband access for better connectivity. This evolution opened the door to new means of communication: Information and Communication Technologies (‘ICT’) in particular, through the widespread use of mobile phones/smartphones. The penetration rate of mobile phones in Africa in 2012 was 65% - 650 million mobiles. The networks’ capacity combined with this unprecedented use of mobiles has inevitably been favourable to the development of a new market: mobile services. By Christophe Fichet, Counsel at Simmons & Simmons LLP, Paris. / read more

Sinikka Salo, Deputy Mayor for the City of Oulu, Finland, the city chosen to lead the Future Health program in Finland, explains why Oulu is leading the way in the innovation of healthcare and how citizens have been empowered to manage and take ownership of their own health data. / 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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