Digital Health Legal

Volume: 0 Issue: 0
(November 2013)


The European Parliament voted on 22 October, on two draft Regulations intended to replace the Medical Devices Directive, the Active Implantable Medical Devices Directive, and the In Vitro Diagnostic Medical Devices Directive. / read more

The botched roll-out of, which went live on 1 October and is designed to allow US citizens to enrol in health insurance plans online - key to the Affordable Care Act (ACA) - illustrates the need for improvements in the US government’s handling of IT projects, particularly in critical areas such as healthcare. / read more

The final Mandate to promote the use of new technology by NHS England was published by the UK Government on 12 November, which includes IT commitments. / read more


Europe's proposed Data Protection Regulation once adopted will have a significant impact on the life sciences and eHealth industries, as William Long, Partner at Sidley Austin LLP explains, especially where the data presents specific risks, such as with health data. / read more

The roll out of the signature project of Australia's eHealth strategy, the Personally Controlled Electronic Health Records (PCEHR), has had a lacklustre start. The vision of the $1 billion PCEHR project was to 'enhance healthcare by enabling access to the right information, for the right person at the right time and right place.' Unfortunately, one year after the launch of the project this vision is far from being realised, as Alec Christie and Jaimie Wolbers of DLA Piper, Australia explain. / read more

Jon Neiditz, Privacy & Information Security Practice Leader at Kilpatrick Townsend & Stockton LLP, summarises lessons learned from eight years of dealing with breach notification laws and managing breach response to attempt to enable legislators, regulators, lawyers and risk managers around the world to be prepared for the misinformation coming their way, with a particular focus on the healthcare industry. / read more

In the first in a series of articles focusing on the regulatory concepts that apply to pharmaceutical companies when engaging in social media activities, Brian Kelly and Grant Castle of Covington & Burling LLP, focus in this first installment on the medicines advertising rules. / read more

In October, cloud-based electronic medical record vendor athenahealth Inc. announced alignment with federally certified Patient Safety Organisation (‘PSO’), Quantros Patient Safety Center (‘QPSC’). Athena's actions are in response to the Office of National Coordinator (‘ONC’) urging vendors to improve patient safety, or risk increased federal regulation. By Laurie Graham, Payer Operations Manager at athenahealth, Inc. / read more

In September, the US Food and Drug Administration ('FDA') issued a long-awaited guidance document: 'Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff' ('Mobile Apps Guidance').The Mobile Apps Guidance outlines the FDA's approach to handling medical apps, including clarifying which apps could be subject to regulation as medical devices in the US and which are likely to fall outside of the FDA's focus. Yarmela Pavlovic, a Partner at Hogan Lovells, Philadelphia, whose practice focuses on the FDA's regulation of medical devices, examines the FDA's guidance document in detail. / read more

Digital-based patient-centred healthcare platforms and services allow patients to actively participate in managing their own care, using personally tailored interactive tools. Such empowerment increases patients' willingness to adopt actions and lifestyles that promote their health, as well as improve follow-up and compliance with treatment in cases of chronic illness. Yossi Bahagon Founder and CEO of Luminox, a company with specialist expertise in the realisation of digital health solutions, and founder of Clalit Health Services (CHS) Digital Health Division, one of Israel’s leading health service organisations, dissects the patient relation management ecosystem in Israel and the keys to its success. / 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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