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 works at Philips as the Head of Global Software Standards. Baird likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and developers, and developing standards, white papers, and training to meet those needs. His current passion is related to artificial intelligence in healthcare; he is co-chair of multiple AI committees including AAMI, ISO/IEC TC215, CTA, MITA, and MDIC.
Eric
Henry
Eric Henry is a 30-year industry veteran currently serving as Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of the law firm King & Spalding. In this role Henry advises King & Spalding clients on a variety of regulatory compliance matters including Quality System establishment and remediation, establishment of quality organizations, audit and inspection management and response, compliance-related due diligence reviews for M&A, training, and serving as an expert witness during litigation. Before he joined King & Spalding, Henry led global quality, compliance, and technology organizations for several large and medium-size medical device companies.
Rohit
Nayak
Rohit Nayak leads Electronic Registry Systems, Inc., a cancer informatics firm. He also serves as an advisor and board member for various early-stage companies and nonprofits. Nayak is a strategic global leader with expertise in digital innovation, commercial execution, and P&L management across Fortune 500 and emerging growth organizations. He has successfully led a healthcare tech start-up from inception to acquisition by a Fortune 500 company. Previously, Nayak formed Baxter’s global Digital Health team and held key roles at Quest Diagnostics, where he grew a P&L for healthcare analytics solutions. He co-founded an ePrescribing software company, later acquired by Quest Diagnostics.
Joining the 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.
THE MEMBERSHIP FEE FOR 2022 WILL BE WAIVED FOR EVERYONE AS WE TRANSITION TO MANAGEMENT OF OUR AI WORK TEAM PROGRAMS UNDER AFDO/RAPS. ANY MEMBER WHO PREVIOUSLY PAID A 2022 MEMBERSHIP FEE WILL RECEIVE A FREE MEMBERSHIP FOR 2023.
