GMLP Work Team Goal
To establish Good Machine Learning Practices (GMLP) that will increase enterprise-wide effectiveness and decrease risk to patients, products, and the overall business.
The GMLP Team is bringing the world of AI activity into one place in order to increase the awareness of good work that has already been done, but also to collaboratively further solutions that address challenges related to AI implementation across the industry.
GMLP Problem Statement
The use of machine learning in the pharmaceutical and medical device industries bears the risks of unanticipated outcomes, unintended (and undetected) degradation in time, confusion for users, and incompatibility of results with other software that may use the output of the evolving algorithm. Good Machine Learning Practices will support the ability of organizations to use AI in a responsible and effective way.
GMLP Deliverables
In February of 2022, the efforts of Xavier Health were assumed by the AFDO/RAPS Healthcare Products Collaborative. Because of the important work done before this transition, the Collaborative has chosen to retain documents that have Xavier branding and continue to provide them to the communities through this website. If you have questions, please contact us at info@healthcareproducts.org.
2022
2021
2019
2018
Team Leaders
Pat
Baird
Pat Baird is the Head of Global Software Standards at Philips, where he describes his role as “Policy Engineering” – addressing the unmet needs and challenges of regulators and developers by creating standards, white papers, and training. He is passionate about artificial intelligence in healthcare and co-chairs several AI committees, including those for AAMI, ISO/IEC TC215, CTA, MITA, and MDIC.
Eric
Henry
Eric Henry, Senior Quality Systems and Compliance Advisor at King & Spalding’s FDA and Life Sciences practice, brings 30 years of industry experience. He advises clients on regulatory compliance, quality systems, audits, M&A due diligence, and serves as an expert witness. Previously, Henry led global quality, compliance, and technology organizations for several medical device companies of varying sizes.
Rohit
Nayak
Rohit Nayak leads Electronic Registry Systems and advises early-stage companies. A strategic leader in digital innovation, he’s grown healthcare tech companies from startup to acquisition, including an ePrescribing company bought by Quest Diagnostics. He formed Baxter’s global Digital Health team and at Quest Diagnostics led healthcare analytics P&L growth. His expertise spans digital health, commercial execution, and P&L management across Fortune 500 and emerging companies.
Joining the GMLP Work Team
You have an opportunity to work with your industry and regulator peers to develop solutions that will advance the predictive capabilities of the industry.
The GMLP Team operates virtually from September through August each year, and is led by a structured leadership team toward predefined goals and deliverables.
The team leaders present the outcome of the work during the AI Summit that occurs each August. You will be recognized for your contributions at the Summit and in team publications.
Meeting frequency and duration is based upon what is needed to support progress against the deliverables. Team members volunteer to work on specific aspects based on their expertise.
If you are interested in joining the GMLP Working Team, please note:
- It is expected that you participate in the standing meetings (schedule is determined by each team).
- Plan on a time commitment of 5 hours per month, but this may vary.
