Good Machine Learning Practices Team

Artificial Intelligence – Advancing the Pharmaceutical and Medical Device Industries

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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 towards 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:

  • There is an annual participation fee of $100 per team to support Healthcare Products Collaborative’s ability to lead these initiatives.
  • 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.

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 Timothy Hsu, Director of Health Technology Initiatives, at thsu@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. Pat likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and developers, and working to develop standards, whitepapers, 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. He has an M.B.A. and a master’s in healthcare quality and patient safety from Northwestern University.

Jackie Karceski

Chief Technology Officer, CAI

Using financial and operational growth expertise, Jackie specializes in helping migrate from ideation to market success through digital transformation. She has over 30 years of experience in Business Finance, Operations and Strategy, Business Development, Funder and Angel Investment, Business Transformation, and Tech Startups.

As CTO of CAI, Jackie’s key responsibilities will be outlining our technological vision, implementing technology strategies, and ensuring that the technological resources are aligned with business needs.

Rohit Nayak

CEO, Electronic Registry Systems, Inc.

Rohit currently leads Electronic Registry Systems, Inc., a cancer informatics firm that is at the forefront of providing cancer programs nationwide with a valuable foundation of data and insights that provide 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.

Rohit 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, startup, and emerging growth organizations, most recently in healthcare. Notably, he’s led a healthcare technology startup from vision to capitalization to execution and eventual sale / exit to a Fortune 500 company.

Most recently, Rohit 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, Rohit 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.