Digital Health Legal

Volume: 1 Issue: 2
(March 2014)


News

Following revelations that Hospital Episode Statistics (HES) data has been sold to an insurers’ body and PA Consulting by its predecessor the NHS Information Centre (NHS IC), the Health and Social Care Information Centre (HSCIC) outlined on 6 March how it will ‘improve the transparency of its decision-making and build public trust in its actions’ in regards to the care.data programme. / read more

Senators D. Fischer and A. King introduced the Preventing Regulatory Overreach To Enhance Care Technology Act 2014 (‘PROTECT’) on 10 February, aimed at creating a more specific regulatory framework for health IT and clarifying the regulatory focus of the Food and Drug Administration (FDA) to include only ‘high-risk’ products. / read more

A new version of the ‘Medical guidelines for advertising regulated health services’ introduced by the Medical Board of Australia, which will take effect on 17 March, has caused concern over requirements that practitioners actively pursue the removal of unsolicited testimonials online. / read more


Features

In January 2014 Greece assumed its six-month Presidency of the European Union; the country presented its priorities in the eHealth area at the beginning of February. Christina Papanikolaou, Secretary General for Public Health of the Hellenic Ministry of Health, and Zoi Kolitsi, a Senior Policy Advisor at the Office of the Secretary General for Public Health, discuss the Presidency’s eHealth agenda and the challenges ahead for accelerating progress. / read more

Information sharing has been the less considered part of the compliance agenda for the NHS in recent years. The reality has been that all health organisations have been able to negotiate the basis and reasons for sharing personal data with few major catastrophes. It’s not that sharing has always been legal or that incidents have not occurred but none have rivaled the problems that engulfed NHS England’s lead information project. By Robin Smith, Chair of Health 2.0 Nottingham think-tank. / read more

One of the most significant barriers to telehealth in the US has been state-based medical licensure requirements. At present, if a physician treats a patient located in Michigan, he/she needs to be licensed by the state of Michigan. This raises issues when remotely treating patients from out-of-state. A number of approaches have been tried to address this issue. The Federation of State Medical Boards, in 1996 published a Model Act to regulate the Practice of Medicine Across State Lines that proposed a telemedicine licence, but the Act did not ‘catch on.’ The National Council of State Boards of Nursing have seen greater success with the Nurse Licensure Compact, which now has 24 States participating in mutual recognition of licensure, including for telehealth, as Anthony T. Pavel and Eric J. Knickrehm of Morgan, Lewis & Bockius LLP explain. / read more

For eHealth providers targeting France’s market, understanding the relevant data protection regime can be challenging. By Ariane Mole, Partner, and Lorraine Maisnier-Boché, Associate, at Bird & Bird, France. / read more

The National Audit Office launched an audit on eHealth implementation in Estonia. The National Audit Office is of the opinion that the Ministry of Social Affairs should deal with the development of the eHealth system more forcefully, as the initially planned objectives have not been achieved. Despite the initial plans, data in the eHealth system cannot yet be fully used for treatment purposes, national statistics, registry keeping or supervision, as Tiik Madis, Senior Adviser at Sitra, a Finnish innovation fund, explains. / read more

On 15 January 2014, the Office of the Privacy Commissioner (‘OPC’) in Canada issued a Report of Findings (‘Report’) on a complaint filed by an individual with sleep apnea, alleging that health information collected from his online browsing activity was improperly used to deliver targeted ads on websites served by Google’s Ad Sense service without his consent. By Christin S. McMeley, Partner, Elizabeth A. Drogula, Associate, and Adam H. Greene, Partner, at Davis Wright Tremaine LLP. / read more

Manoj Vaghela, product liability expert and Partner at Pinsent Masons LLP, looks at the uncertain regulatory framework that applies to mHealth in the EU and the considerations for mHealth app developers. / read more

The European Committee on Civil Liberties, Justice and Home Affairs (LIBE) amendments to the draft EU General Data Protection Regulation could severely restrict the use of identifiable personal data in medical research, as Valerie Surgenor of MacRoberts law firm explains. / read more

The Federal Court, the highest civil court of Germany, has decided that, under certain conditions, an advertisement for a drug does not need to cover the ‘essential information.’ This ruling enables pharma companies to use Google AdWords in the advertising of over-the-counter (‘OTC’) drugs to the general public1. By Jana Grieb, Counsel at McDermott Will & Emery Rechtsanwälte Steuerberater LLP, Munich. / 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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