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In Healthtech

New Trial Standards for AI Medical Solutions

by 4 Mins Read

New guidelines have been published on clinical trials for AI health solutions. The SPIRIT-AI extension relates to clinical trials protocols, and the CONSORT-AI extension is a new reporting guideline for clinical trial reports. These new guidelines are aimed at addressing some of the chronic issues which often underlie trial standards for AI, including the use of retrospective datasets, poor standards of reporting and lack of transparency. We’ve described these issues below: 1. Retrospective reports do…

In Healthtech

Medical Confidentiality in the UK: 4 Key Changes Proposed to the Caldicott Principles

by 3 Mins Read

The UK’s National Data Guardian for Health and Social Care (NDG) is carrying out a consultation seeking views on proposed revisions to the seven Caldicott Principles. The consultation is open until 3rd September. We’ve set out a summary of 4 key changes proposed in the NDG’s consultation paper. What are the Caldicott Principles? In 1997, Dame Fiona Caldicott chaired a committee which produced a report containing six principles on patient confidentiality after reviewing the transfer…

In Healthtech

Legal Aspects of Citizen Science in Video Games

by 3 Mins Read

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…

In Healthtech

How to get Governmental Funding for Digital Health Apps in Germany

by , and 1 Min Read

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…

In Healthcare & Life Sciences

Delay of MDR Implementation and its Implications on Brexit

by 3 Mins Read

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…

In Healthcare & Life Sciences

Digital health solutions: Top legal issues in the UK, France, Germany, Italy, Russia and Spain

by and 1 Min Read

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.…

In Data Privacy

Ontario Amends the Personal Health Information Protection Act

by and 3 Mins Read

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…

In Artificial Intelligence

New NHS Guidance in the UK: 10 Questions for Hospitals buying AI

by 4 Mins Read

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…

In Data Privacy

OCR Issues Notification of Enforcement Discretion for Business Associate Disclosures

by , and 3 Mins Read

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…

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