This is the seventh of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: are healthcare providers involved, and what questions should be considered for collaborations?
Ideation Question #6: What Are the Limits on How the Data Can Be Used and Disclosed?
This is the sixth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: what are the limits on how the data can be used and disclosed?
Ideation Question #5: Who Will Pay for the Offering?
This is the fifth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: who will pay for the offering?
Ideation Question #4: What Data Will Be Needed to Substantiate the Offering?
Ideation Question #3: Who Will Supply the Data?
This is the third of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: who will provide the data used in the offering?
Ideation Question #2: Who Will Provide Aspects of the Offering?
This is the second of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: who will provide the various components of the offering?
Top 10 Questions During Ideation of Digital Health Solutions
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…
UK Government’s Guide to Using AI in the Public Sector
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.…
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NMPA Releases Draft Good Manufacturing Practice Appendix on Standalone Software
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:…
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UK Government publishes new policy paper outlining vision for digitizing health care and becoming a global leader in healthtech
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…