Good Machine Learning Practices Team
AI Working Teams > GMLP
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.
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.
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:
* 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.
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.
Team Leaders
Pat Baird
Regulatory Head of Global Software Standards, Philips
Pat Baird works at Philips as the Head of Global Software Standards. He likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and developers, and working to develop standards, white papers, and training to meet those needs.
Past roles have included software developer, engineering manager, project manager, lead engineer, and most recently he was the Director of Risk Management at Baxter Healthcare. Drawing on 20 years’ experience in product development, he has published and presented over 50 papers regarding product development. Baird has an MBA and a master’s in healthcare quality and patient safety from Northwestern University.
Eric Henry
Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
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
CEO, Electronic Registry Systems, Inc.
Rohit Nayak currently leads Electronic Registry Systems, Inc., a cancer informatics firm at the forefront of providing cancer programs nationwide with a valuable foundation of data and insights for the best cancer care for every patient. He also serves as an Advisor/Board Member for several early stage companies and not-for-profit organizations.
Nayak has a successful track record as strategic global leader and change catalyst, leveraging digital innovation, commercial execution, and P&L management skills across Fortune 500, start-up, and emerging growth organizations, most recently in healthcare. Notably, he’s led a healthcare technology start-up from vision to capitalization to execution and eventual sale / exit to a Fortune 500 company.
Most recently, Nayak led the formation of the global Digital Health team at Baxter with responsibilities to drive innovative software-enabled solutions, leveraging their med device portfolio. Prior to Baxter, he had several roles with increasing responsibilities at Quest Diagnostics where he was responsible for successfully developing and growing a P&L delivering customer-facing healthcare analytics solutions across the ambulatory, acute, and payer markets. He previously co-founded and led an ePrescribing healthcare software company that was subsequently acquired by Quest Diagnostics.