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For some time now, start-ups, health care and tech companies have been experimenting with smaller video games to have people around the world help with categorizing or analyzing big data sets that typically take months or even years to analyze. The idea is that if everybody invests only a few minutes, the work could be done in days or weeks instead of years. A player who participates has to solve a few simple matchmaking or…

The Digital-Supply-Act (Digitale-Versorgung-Gesetz, “DVG”), which aims to further promote digitization in the German health care system, entered into force on 19 December 2019 and regulates, inter alia, the prescription of Digital Health Apps by HCPs (including the cost bearing by statutory health insurance). Patients insured with statutory health funds are eligible for reimbursement of Digital Health Apps. As of this August, prescription for Digital Health Apps will be available, according to statements made by the…

Delay of MDR Implementation and its Implications for Brexit The recent postponement of the Medical Device Regulation 2017/745 (“MDR”) means its full application will now fall beyond the end of the Brexit transition period. This could have a huge impact on the UK’s legal framework for medical device regulation after Brexit. Background The MDR repeals the existing Medical Device Directive 94/32/EEC (“MDD”). The MDR came into force on 25 May 2017, and originally, approved medical…

Are you developing a digital health solution with cross-border reach? Whether your company is new to the digital health space, or enhancing its existing digital health offering in response to COVID‑19, we’ve got you covered on the top legal issues. Take a look at our survey covering key markets like the UK, France, Germany, Italy, Russia and Spain. COVID‑19 is accelerating the adoption of digital health solutions by hospitals and medical institutions around the world.…

On March 25, 2020, Ontario enacted significant amendments to the Personal Health Information Protection Act (PHIPA). The changes create a more robust enforcement mechanisms and increased regulation of the use of electronic health records. Some amendments took effect immediately upon enactment, while others will come into force on a day to be proclaimed by the Lieutenant Governor. Notable changes to PHIPA that took effect immediately upon enactment include: a new enforcement regime allowances for the…

NHS AI Lab has released a short buyer’s checklist to guide organisations through procuring AI solutions. It’s been published in light of COVID-19 – the pandemic presents a huge opportunity to accelerate the uptake of innovative digital solutions at scale. In the UK, healthcare organisations are receiving multiple proposals for AI healthcare applications. This could ease the burden on hospitals facing enormous demands on time and clinical resource. The guide focuses on providing assurance that…

Further to our March 25th update and the guidance issued by the Office of Civil Rights (OCR) in late March, OCR has issued an additional Notification of Enforcement Discretion, allowing for enforcement discretion regarding additional uses and disclosures of protected health information (PHI) for public health and health oversight activities during the COVID-19 pandemic. Under the Health Insurance Portability and Accountability Act (HIPAA)’s Privacy Rule, business associates are generally only permitted to use and disclose…

NHSX, the technology and digital unit of the UK’s National Health Service (NHS), recently published its draft Digital Health Technology Standard. The Standard aims to accelerate how digital health technologies (DHTs) are reviewed, commissioned and scaled for use across the wider health and care system, and provides guidance to support digital health technology developers. The Standard is in draft form at the moment, and NHSX are seeking feedback via a short survey until 22 April (although…

In this episode of Connect On Tech, your host Brian Hengesbaugh is joined by Amy de La Lama, a partner in our Chicago office. Amy and Brian discuss a top of mind topic: telehealth, and the changes to US privacy regulations or enforcement priorities that evolve in response to the COVID-19 pandemic. You will hear: A summary of the current regulatory environment in the US regarding to privacy and telehealthHow US authorities taken steps to…