Digital Health Legal

Volume: 2 Issue: 12
(December 2015)


The first extraction will take place from GPs in December of opt-out requests from patients who opted-out of the initiative or from their data being shared with third parties by the UK’s Health and Social Care Information Centre (‘HSCIC’), following the Government leaflet campaign about the initiative in January 2014. According to HSCIC, all objections are set to be implemented in January 2016. / read more

The IEEE Standards Association (‘IEEE-SA’) published in a press release on 4 November details of the Biometrics Open Protocol Standard (‘BOPS’), alongside two standards development projects - a Draft Standard For Enabling Mobile Device Platforms To Be Used As Pre-Screening Audiometric Systems and a Draft Standard For Bio-CAD File Format for Medical Three-Dimensional (3D) Printing - all of which look to support interoperable communications on eHealth devices. / read more

The US Food and Drug Administration (‘FDA’) released a Social Media Policy on 13 November, which defines processes and expectations for FDA employees using social media. / read more


The Dutch Data Protection Authority (College bescherming persoonsgegevens, hereinafter ‘CBP’) published a report on 11 November following an investigation into Nike’s fitness app, the Nike+ Running app. The CBP found several violations of data protection law, according to its nearly hundred-page report. The report is interesting in that it provides detailed insight into how the Dutch Data Protection Authority views personal data concerning health and the thought processes behind the concept of health data, as Sofie van der Meulen and Erik Vollebregt of Axon Lawyers explain. / read more

At the end of October Hungary finished the IT development for its National Health Information Technology (eHealth) System, which will now be subject to a test phrase, while the legal framework underpinning the System is constructed. The System will enable medical documentation relating to patients to be available, with the patient’s permission, to medical practitioners at any time and in any place, while patients will themselves be able to access their documentation through a governmental website. Márton Domokos, Senior Counsel at CMS Cameron McKenna LLP describes the status and aims of the System and the regulatory environment in which it exists. / read more

In August 2013 the US Federal Trade Commission (‘FTC’) filed an administrative complaint against medical company LabMD on the basis of alleged failings in regards to the security of personal information of patients on LabMD’s computer network. In the latest development, on 19 November an Administrative Law Judge at the FTC dismissed the case against LabMD, in a move that has surprised some. Patricia Wagner, Member at Epstein Becker Green, discusses the background to the decision and the Judge’s findings of fact. / read more

Alexis Gilroy, Cristiana Spontoni, Colleen Heisey and Indra Bhattacharya of Jones Day review the regulation of telemedicine applications in the EU and the US, and how medical device regulation underpins this. / read more

In the UK, the Caldicott review summed up the challenge: “When it comes to sharing information, a culture of anxiety permeates the health and social care sector [...]. This state of affairs is profoundly unsatisfactory and needs to change.” In the US, the issue of interoperability has reached a critical point, particularly as new organisational structures such as accountable care organisations (‘ACOs’) and patient-centred medical homes (‘PCMH’) have effective information sharing built into them. This is reflected in government policy and industry initiatives to address technical and governance challenges. In parallel, as health data digitisation continues to mature, we see the growing adoption of analytics (also referred to as business intelligence, ‘BI’) across healthcare organisations. Analytics are being used to help improve the quality and experience of care, improve efficiency and reduce costs at both a macro and micro level. Usage cases include optimising medicines management and supply chain and improving and tailoring clinical decision support. / read more

On 9 November the White House published a final set of Privacy and Trust Principles intended to guide the Precision Medicine Initiative in the US. These Principles are essentially broad guidelines to assist in balancing the value of sharing the huge amount of data the Precision Medicine Initiative is set to generate with the need to protect the privacy and security of research participants. The Principles are set down along six themes, which include governance, transparency and integrity. Barbara Cammarata, Counsel at Sidley Austin LLP, analyses the Principles and the intentions behind them. / read more

In its latest report, the Health IT Knowledge Institute (Nictiz) suggests that eHealth in the Netherlands is still realising its potential. Recognising this the Dutch Ministry of Health, Welfare and Sport is taking steps to accelerate eHealth adoption and has formulated three goals, to be reached by 2019. Hylke Kingma, Senior Manager at Deloitte, discusses the Ministry’s three goals. / 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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