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Healthtech

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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…

Whether your company is new to the digital health space, or enhancing its existing digital health offering in response to COVID-19, here are our top 5 legal issues to bear in mind as you embark on your journey. COVID-19 is accelerating the adoption of digital health solutions by hospitals and medical institutions around the world. Companies are innovating at lightning speed to adapt to new needs: patients are being treated remotely through mobile doctor apps,…

In response to the COVID-19 global pandemic, on March 17, 2020, the Office of Civil Rights (OCR) at the US Department of Health and Human Services (HHS), the agency charged with enforcing the Health Insurance Portability and Accountability Act of 1996 (HIPAA), issued the Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (“Guidance”). On March 20, OCR issued supplemental guidance on provision of telehealth services in the form…

Manufacturers are being urged by governments around the world to expand production to include life-saving medical technology to tackle COVID-19. We’ve produced an alert (here) to help guide manufacturers which are new to this space on key legal challenges. As COVID-19 infections increase globally, health systems face a shortage of life-saving equipment and essential supplies to tackle the virus. Until a pharmacological treatment is developed, ventilators are vital treatment for the minority of COVID-19 patients…

In this episode of Connect On Tech, your host Brian Hengesbaugh is joined by Ben McLaughlin, Global Chair of Baker McKenzie’s Healthcare & Life Sciences Group. Together Brian and Ben discuss healthcare data in the context of mergers and acquisitions. You will hear: An outline of the major players and issues surrounding acquisition of healthcare data.The number one issue keeping healthcare GCs up at night.Details on regulatory restrictions emerging to protect healthcare data. https://open.spotify.com/episode/51ImY8zLWMKH2IWr2z2PCU Related…

A new report provides a bold roadmap for the NHS to maximise the impact of its health data. The report, titled NHS data: Maximising its impact on the health and wealth of the United Kingdom, advocates for the UK government to take action now, before the UK is leapfrogged by other countries in health innovation. The report (available here) is from Imperial College London’s Institute of Global Health Innovation. The report examines some of the…