Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions.  “Ideation” is the part of that process and involves the rapid identification and creation of ideas for digital health solutions, which are then prototyped and tested.  Covington has created a Top 10 Questions for Ideation of Digital Health

On June 10, 2019, the UK Government’s Digital Service and the Office for Artificial Intelligence released guidance on using artificial intelligence in the public sector (the “Guidance”).  The Guidance aims to provide practical guidance for public sector organizations when they implement artificial intelligence (AI) solutions.

The Guidance will be of interest to companies that provide AI solutions to UK public sector organizations, as it will influence what kinds of AI projects public sector organizations will be interested in pursuing, and the processes that they will go through to implement AI systems.  Because the UK’s National Health Service (NHS) is a public sector organization, this Guidance is also likely to be relevant to digital health service providers that are seeking to provide AI technologies to NHS organizations.

The Guidance consists of three sections: (1) understanding AI; (2) assessing, planning and managing AI; (3) using AI ethically and safely, as summarized below. The guidance also has links to summaries of examples where AI systems have been used in the public sector and elsewhere.

Continue Reading UK Government’s Guide to Using AI in the Public Sector

On January 3, 2019, the National Medical Products Administration (“NMPA”) published a draft standalone software appendix of medical device good manufacturing practice (“Draft Standalone Software GMP” or “Draft Appendix”) for public comment (available here).  Comments are due on January 30, 2019.

China revised its medical device GMP in 2014, which apply to all classes of devices regardless of whether they are imported or made in China.  Subsequently, NMPA added various appendices (fulu) to articulate special requirements for certain types of devices, including sterile, implantable, and in vitro diagnostic devices.    The Draft Appendix sets out proposed special requirements for software that falls under the definition of medical device.

In China, the definition of a medical device covers software that either itself constitutes a device (i.e., standalone software) or is an accessory/component of a device (i.e., component software).  The Draft Standalone Software GMP expressly applies to standalone software and it states that it applies, “by reference,” (mutatis mutandis) to component software.  If finalized, the Draft Standalone Software GMP would be effective on an undetermined date in 2020.

The Draft Appendix is a relatively simple document with four main sections:

  • scope and general principles of the Draft Appendix ;
  • special requirements for various aspects of the manufacturing and post-market processes (see below);
  • definitions of key terms; and
  • miscellaneous provisions.

Key features of the Draft Standalone Software GMP include the following:

Continue Reading NMPA Releases Draft Good Manufacturing Practice Appendix on Standalone Software

On 17 October, the UK Government’s Department of Health and Social Care (DHSC) published a policy paper entitled “The future of healthcare: our vision for digital, data and technology in health and care” (the Policy Paper). The Policy Paper outlines the DHSC’s vision to use technology across the health and

Designing data-driven products and services in compliance with privacy requirements can be a challenging process.  Technological innovation enables novel uses of personal data, and companies designing new data-driven products must navigate new, untested, and sometimes unclear requirements of privacy laws, including the General Data Protection Regulation (GDPR).  These challenges are often particularly acute for companies providing products and services leveraging artificial intelligence technologies, or operating with sensitive personal data, such as digital health products and services.

Recognising some of the above challenges, the Information Commissioner’s Office (ICO) has commenced a consultation on establishing a “regulatory sandbox”.  The first stage is a survey to gather market views on how such a regulatory sandbox may work (Survey).  Interested organisations have until 12 October to reply.

The key feature of the regulatory sandbox is to allow companies to test ideas, services and business models without risk of enforcement and in a manner that facilitates greater engagement between industry and the ICO as new products and services are being developed.

The regulatory sandbox model has been deployed in other areas, particularly in the financial services sector (see here), including by the Financial Conduct Authority in the UK (see here).

Potential benefits of the regulatory sandbox include reducing regulatory uncertainty, enabling more products to be brought to market, and reducing the time of doing so, while ensuring appropriate protections are in place (see the FCA’s report on its regulatory sandbox here for the impact it has had on the financial services sector, including lessons learned).

The ICO indicated earlier this year that it intends to launch the regulatory sandbox in 2019 and will focus on AI applications (see here).

Further details on the scope of the Survey are summarised below.

Continue Reading ICO consults on privacy “regulatory sandbox”