Digital Health Legal

Volume: 4 Issue: 11
(November 2017)


The UK Department of Health (‘DOH’) published the 2017/18 Data Security and Protection Requirements (the ‘Requirements’) on 30 October 2017, which set out the steps all health and care organisations will be expected to take in order to demonstrate that they are putting into practice the ten data security standards recommended by the National Data Guardian in the ‘National Data Guardian for Health and Care’s Review of Data Security, Consent and Opt-Outs.’ / read more

The U.S. Food and Drug Administration (‘FDA’) published on 30 October 2017 the final version of its guidance, ‘Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request’ (‘Guidance’), clarifying that the FDA’s requirements do not prevent manufacturers of medical devices which store inputs from healthcare providers regarding a patient’s status and ongoing treatment, or that record information about usage, alarms or outputs, from sharing patient-specific data recorded by the device with the patient diagnosed by or being treated with that device. “This is a circumstance in which the FDA is clarifying a question on which it has not previously provided guidance. The purpose of the Guidance is to facilitate sharing of data with patients when that is requested by the patient, but only if the manufacturer already has access to the information and does not need to alter the device in order to obtain the requested information,” explains Yarmela Pavlovic, Partner at Hogan Lovells. / read more


On 14 September 2017, the UK Government announced the publication of the Data Protection Bill (‘the Bill’). The key purposes of the Bill are to implement and supplement the EU General Data Protection Regulation (‘GDPR’); repeal and replace the existing Data Protection Act 1998 (‘DPA’); outline where and how the UK will exercise its right to derogate from certain GDPR provisions; and update and strengthen UK law to make the shift to the GDPR (and the UK’s transition out of the EU and, potentially, the EEA) as simple and as smooth as possible for businesses and individuals operating within the UK. Marcus Vass, Partner and Co-head of the Digital Health Group, and Jane Whitcombe, Senior Associate, at Osborne Clarke LLP, analyse the Bill in the context of digital health. / read more

With the introduction of new regulations and initiatives such as the Startup India campaign, and more recently the new Medical Device Rules 2017 (GSR 78E) - set to take effect from January 2018 - the Indian Government has made significant steps towards streamlining the development processes that impact digital health. Dr Milind Antani, of Nishith Desai Associates, provides his analysis of the changes taking place, and the impact that they will have going forward. / read more

The EU-funded project My Health My Data (‘MHMD’) looks to introduce a new way of sharing medical information and empowering their primary owner, the patient, using encryption solutions and the blockchain. Here, Rocco Panetta and Lorenzo Cristofaro of P&A | Panetta & Associati, who have been involved in the MHMD project since its initial proposal to the European Commission, explain the aims and value of the MHMD project. / read more

In October 2017 the UAE Government used a cabinet reshuffle to appoint its first minister for artificial intelligence (‘AI’). This development highlights the seriousness with which the UAE is taking the fields of AI and robotics, which have seen increasing demand, including within the health sector, in the Middle East. Hamish Clark, Rasha Saleh and Siham Awada of PwC detail how AI and robotics are transforming healthcare and their adoption so far, and assess some of the questions to be addressed as this development continues. / read more

Despite being a world leader in the development of digital health technologies, developers in the US are often apprehensive about the often long and detailed process of the Food and Drug Administration’s (‘FDA’) premarket certification review. The FDA’s new Digital Health Software Precertification (Precert) Program (‘Precert Program’), announced in August 2017, seeks to pilot a ‘fast-track’ process for software as a medical device (‘SAMD’) developers that the FDA trusts to produce consistently high quality, safe and secure products, removing the necessity to undergo the full review process for each product produced. Jeffrey K. Shapiro, Director at Hyman, Phelps & McNamara, provides background to and discussion of the FDA’s review processes and its new Precert Program, and considers the impact the Precert Program may have on the digital health market. / 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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