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…
The health care sector continues to be increasingly driven by technology and electronic environments. Electronic health records (“EHR”) have, in many clinical settings, replaced traditional paper charts. Clinical information systems are consolidating years of patient data, and advances in medical technologies are generating new types of data and data sets that never before existed. The development of health information technology (“HIT”) has led to an unprecedented increase in the volume of health care data. As…