Digital Health Legal

Volume: 1 Issue: 1
(February 2014)


The Health and Social Care Information Centre (HSCIC) will begin extracting patients' data from GP practices across the UK this Spring *[update at the end of the article] as part of its programme, which will see healthcare data in anonymised, pseudonymised or aggregated form sold for secondary use to 'any organisation' which goes through an application and meets the conditions for release. / read more

Rep. D. Matsui and Rep. B. Johnson introduced to the US House of Representatives on 17 December the Telehealth Modernization Act, a bill designed inter alia to provide a working federal definition for telehealth and to create baseline standards for safe telehealth, in order to reduce obstacles to telehealth access created by differing state laws. / read more

The Central Government of India has formed a national e-Health Record System to collect and share the health records of patients that visit any hospital in the country, it was announced by Ravinder Kumar Jain, Additional Secretary of the Ministry of Health and Family Welfare at the 17th National Conference on e-Governance in Kochi, held on 30-31 January. / read more


Pēteris Zilgalvis, Visiting European Union Fellow at St. Antony’s College, University of Oxford, and Head of Unit for eHealth and Well Being in DG Communications Networks, Content and Technology (CNECT) at the European Commission, discusses in this article the importance of innovation in eHealth and Well Being and the importance of the state and private sector in fostering such innovation. / read more

Since the HIPAA Privacy Rule first required compliance in 2003, enforcement of the privacy and security obligations has been very limited. In recent years, enforcement has increased, but there remains only a handful of actions. Now, with the implementation of new HIPAA privacy, security and breach notification requirements, the expansion of HIPAA enforcement authority, the upcoming departure of the head of the primary HIPAA enforcement agency, and potential enforcement ‘competition’ from the FTC, Kirk J. Nahra, a Partner with Wiley Rein LLP in Washington, asks what can we expect in HIPAA enforcement in the years ahead? / read more

Whilst Ireland has a global reputation in pharmaceutical and medical device manufacturing and information technology, in recent years it has lagged behind some of its European neighbours in embracing eHealth. The Irish Government is now seeking to develop the obvious synergies between well established healthcare and technology sectors to position Ireland at the forefront of the delivery of eHealth services with the publication of an eHealth Strategy for Ireland in December 2013 and the publication of the long awaited Health Identifiers Bill 2013. Adam Finlay, Solictor at McCann FitzGerald Solicitors, assesses the recent developments and what he believes is the Government’s primary focus in developing the commercial potential of eHealth, particularly as a potential source of export-based services and jobs, rather than on the rapid implementation of eHealth to overhaul the Irish health system. / read more

From medicine to mobile app to medicine, Anand K. Iyer, President and Chief Operating Officer of WellDoc, a US healthcare company that uses technology to improve disease management outcomes and reduce healthcare costs, presents WellDoc’s story from medicine to mobile app via the US Food and Drug Administration. / read more

With the intention of standardising the collection, management, and sharing of personal health information, and safeguarding the security and privacy of such information in China, the National Health and Family Planning Commission of the People’s Republic of China published a draft version of the ‘Measures on Administration of the Personal Health Information (Pilot Regulation)’ for public comment on 18 November 2013. The enactment of these Draft Measures represents the Chinese Government’s efforts to establish a centralised nationwide system to administrate and protect the personal health information of its citizens, as Sherry Zhang and Vincent Wang of Davis Wright Tremaine LLP, Shanghai, explain. / read more

There is little doubt that social media has transformed advertising and product promotion. However, in the US, pharmaceutical manufacturers have been cautious in embracing these new opportunities. This, in part, is because the regulations and guidance offered by the US Food and Drug Administration (FDA) provides relatively little guidance regarding product promotion through social media. Dena Feldman and Scott Danzis of Covington & Burling LLP, discuss the FDA’s latest guidance and the need for more clarity. / read more

Erik Vollebregt, Founding Partner and EU legal medical technology specialist of boutique life sciences firm Axon Lawyers, explains why he thinks the EU is hindering innovation in the mHealth space and the issues faced by his clients. / read more

In a complaint filed in August 2013, the FTC alleged that LabMD, a Georgia-based company providing clinical laboratory services, had two data security breaches that affected information belonging to 10,000 consumers. René Quashie, Senior Counsel and regulatory specialist on issues related to eHeath and telemedicine in the Washington, DC office of Epstein Becker Green, dissects the LabMD decision and its ramifications. / read more

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has decided to implement requirements for detailed online disclosure regarding the nature and scale of the interactions between industry on the one hand and healthcare professionals and organisations on the other. Marc L. Holtorf and Anne Britta Haas of Clifford Chance’s Healthcare, Life Science & Chemicals sector group, discuss the obligations and challenges. / 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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