Open-Source Clinical Machine Learning Models: Critical Appraisal of Feasibility, Advantages, and Challenges

Machine learning applications promise to augment clinical capabilities and at least 64 models have already been approved by the US Food and Drug Administration. These tools are developed, shared, and used in an environment in which regulations and market forces remain immature. An importa...

Full description

Bibliographic Details
Main Authors: Keerthi B Harish, W Nicholson Price, Yindalon Aphinyanaphongs
Format: Article
Language:English
Published: JMIR Publications 2022-04-01
Series:JMIR Formative Research
Online Access:https://formative.jmir.org/2022/4/e33970
_version_ 1797735204831363072
author Keerthi B Harish
W Nicholson Price
Yindalon Aphinyanaphongs
author_facet Keerthi B Harish
W Nicholson Price
Yindalon Aphinyanaphongs
author_sort Keerthi B Harish
collection DOAJ
description Machine learning applications promise to augment clinical capabilities and at least 64 models have already been approved by the US Food and Drug Administration. These tools are developed, shared, and used in an environment in which regulations and market forces remain immature. An important consideration when evaluating this environment is the introduction of open-source solutions in which innovations are freely shared; such solutions have long been a facet of digital culture. We discuss the feasibility and implications of open-source machine learning in a health care infrastructure built upon proprietary information. The decreased cost of development as compared to drugs and devices, a longstanding culture of open-source products in other industries, and the beginnings of machine learning–friendly regulatory pathways together allow for the development and deployment of open-source machine learning models. Such tools have distinct advantages including enhanced product integrity, customizability, and lower cost, leading to increased access. However, significant questions regarding engineering concerns about implementation infrastructure and model safety, a lack of incentives from intellectual property protection, and nebulous liability rules significantly complicate the ability to develop such open-source models. Ultimately, the reconciliation of open-source machine learning and the proprietary information–driven health care environment requires that policymakers, regulators, and health care organizations actively craft a conducive market in which innovative developers will continue to both work and collaborate.
first_indexed 2024-03-12T12:54:39Z
format Article
id doaj.art-81d6c8258ab34b73bf67c386ec0ed676
institution Directory Open Access Journal
issn 2561-326X
language English
last_indexed 2024-03-12T12:54:39Z
publishDate 2022-04-01
publisher JMIR Publications
record_format Article
series JMIR Formative Research
spelling doaj.art-81d6c8258ab34b73bf67c386ec0ed6762023-08-28T21:22:39ZengJMIR PublicationsJMIR Formative Research2561-326X2022-04-0164e3397010.2196/33970Open-Source Clinical Machine Learning Models: Critical Appraisal of Feasibility, Advantages, and ChallengesKeerthi B Harishhttps://orcid.org/0000-0001-9244-7253W Nicholson Pricehttps://orcid.org/0000-0003-0729-290XYindalon Aphinyanaphongshttps://orcid.org/0000-0001-8605-5392 Machine learning applications promise to augment clinical capabilities and at least 64 models have already been approved by the US Food and Drug Administration. These tools are developed, shared, and used in an environment in which regulations and market forces remain immature. An important consideration when evaluating this environment is the introduction of open-source solutions in which innovations are freely shared; such solutions have long been a facet of digital culture. We discuss the feasibility and implications of open-source machine learning in a health care infrastructure built upon proprietary information. The decreased cost of development as compared to drugs and devices, a longstanding culture of open-source products in other industries, and the beginnings of machine learning–friendly regulatory pathways together allow for the development and deployment of open-source machine learning models. Such tools have distinct advantages including enhanced product integrity, customizability, and lower cost, leading to increased access. However, significant questions regarding engineering concerns about implementation infrastructure and model safety, a lack of incentives from intellectual property protection, and nebulous liability rules significantly complicate the ability to develop such open-source models. Ultimately, the reconciliation of open-source machine learning and the proprietary information–driven health care environment requires that policymakers, regulators, and health care organizations actively craft a conducive market in which innovative developers will continue to both work and collaborate.https://formative.jmir.org/2022/4/e33970
spellingShingle Keerthi B Harish
W Nicholson Price
Yindalon Aphinyanaphongs
Open-Source Clinical Machine Learning Models: Critical Appraisal of Feasibility, Advantages, and Challenges
JMIR Formative Research
title Open-Source Clinical Machine Learning Models: Critical Appraisal of Feasibility, Advantages, and Challenges
title_full Open-Source Clinical Machine Learning Models: Critical Appraisal of Feasibility, Advantages, and Challenges
title_fullStr Open-Source Clinical Machine Learning Models: Critical Appraisal of Feasibility, Advantages, and Challenges
title_full_unstemmed Open-Source Clinical Machine Learning Models: Critical Appraisal of Feasibility, Advantages, and Challenges
title_short Open-Source Clinical Machine Learning Models: Critical Appraisal of Feasibility, Advantages, and Challenges
title_sort open source clinical machine learning models critical appraisal of feasibility advantages and challenges
url https://formative.jmir.org/2022/4/e33970
work_keys_str_mv AT keerthibharish opensourceclinicalmachinelearningmodelscriticalappraisaloffeasibilityadvantagesandchallenges
AT wnicholsonprice opensourceclinicalmachinelearningmodelscriticalappraisaloffeasibilityadvantagesandchallenges
AT yindalonaphinyanaphongs opensourceclinicalmachinelearningmodelscriticalappraisaloffeasibilityadvantagesandchallenges