scholarly journals Addressing health disparities in the Food and Drug Administration’s artificial intelligence and machine learning regulatory framework

2020 ◽  
Vol 27 (12) ◽  
pp. 2016-2019
Author(s):  
Kadija Ferryman

Abstract The exponential growth of health data from devices, health applications, and electronic health records coupled with the development of data analysis tools such as machine learning offer opportunities to leverage these data to mitigate health disparities. However, these tools have also been shown to exacerbate inequities faced by marginalized groups. Focusing on health disparities should be part of good machine learning practice and regulatory oversight of software as medical devices. Using the Food and Drug Administration (FDA)'s proposed framework for regulating machine learning tools in medicine, I show that addressing health disparities during the premarket and postmarket stages of review can help anticipate and mitigate group harms.

Author(s):  
Hao-yu Liao ◽  
Willie Cade ◽  
Sara Behdad

Abstract Accurate prediction of product failures and the need for repair services become critical for various reasons, including understanding the warranty performance of manufacturers, defining cost-efficient repair strategies, and compliance with safety standards. The purpose of this study is to use machine learning tools to analyze several parameters crucial for achieving a robust repair service system, including the number of repairs, the time of the next repair ticket or product failure, and the time to repair. A large dataset of over 530,000 repairs and maintenance of medical devices has been investigated by employing the Support Vector Machine (SVM) tool. SVM with four kernel functions is used to forecast the timing of the next failure or repair request in the system for two different products and two different failure types, namely random failure and physical damage. A frequency analysis is also conducted to explore the product quality level based on product failure and the time to repair it. Besides, the best probability distributions are fitted for the number of failures, the time between failures, and the time to repair. The results reveal the value of data analytics and machine learning tools in analyzing post-market product performance and the cost of repair and maintenance operations.


2021 ◽  
Author(s):  
Nawar Shara ◽  
Kelley M. Anderson ◽  
Noor Falah ◽  
Maryam F. Ahmad ◽  
Darya Tavazoei ◽  
...  

BACKGROUND Healthcare data are fragmenting as patients seek care from diverse sources. Consequently, patient care is negatively impacted by disparate health records. Machine learning (ML) offers a disruptive force in its ability to inform and improve patient care and outcomes [6]. However, the differences that exist in each individual’s health records, combined with the lack of health-data standards, in addition to systemic issues that render the data unreliable and that fail to create a single view of each patient, create challenges for ML. While these problems exist throughout healthcare, they are especially prevalent within maternal health, and exacerbate the maternal morbidity and mortality (MMM) crisis in the United States. OBJECTIVE Maternal patient records were extracted from the electronic health records (EHRs) of a large tertiary healthcare system and made into patient-specific, complete datasets through a systematic method so that a machine-learning-based (ML-based) risk-assessment algorithm could effectively identify maternal cardiovascular risk prior to evidence of diagnosis or intervention within the patient’s record. METHODS We outline the effort that was required to define the specifications of the computational systems, the dataset, and access to relevant systems, while ensuring data security, privacy laws, and policies were met. Data acquisition included the concatenation, anonymization, and normalization of health data across multiple EHRs in preparation for its use by a proprietary risk-stratification algorithm designed to establish patient-specific baselines to identify and establish cardiovascular risk based on deviations from the patient’s baselines to inform early interventions. RESULTS Patient records can be made actionable for the goal of effectively employing machine learning (ML), specifically to identify cardiovascular risk in pregnant patients. CONCLUSIONS Upon acquiring data, including the concatenation, anonymization, and normalization of said data across multiple EHRs, the use of a machine-learning-based (ML-based) tool can provide early identification of cardiovascular risk in pregnant patients. CLINICALTRIAL N/A


Author(s):  
Shatakshi Singh ◽  
Kanika Gautam ◽  
Prachi Singhal ◽  
Sunil Kumar Jangir ◽  
Manish Kumar

The recent development in artificial intelligence is quite astounding in this decade. Especially, machine learning is one of the core subareas of AI. Also, ML field is an incessantly growing along with evolution and becomes a rise in its demand and importance. It transmogrified the way data is extracted, analyzed, and interpreted. Computers are trained to get in a self-training mode so that when new data is fed they can learn, grow, change, and develop themselves without explicit programming. It helps to make useful predictions that can guide better decisions in a real-life situation without human interference. Selection of ML tool is always a challenging task, since choosing an appropriate tool can end up saving time as well as making it faster and easier to provide any solution. This chapter provides a classification of various machine learning tools on the following aspects: for non-programmers, for model deployment, for Computer vision, natural language processing, and audio for reinforcement learning and data mining.


2020 ◽  
pp. 799-810
Author(s):  
Matthew Nagy ◽  
Nathan Radakovich ◽  
Aziz Nazha

The volume and complexity of scientific and clinical data in oncology have grown markedly over recent years, including but not limited to the realms of electronic health data, radiographic and histologic data, and genomics. This growth holds promise for a deeper understanding of malignancy and, accordingly, more personalized and effective oncologic care. Such goals require, however, the development of new methods to fully make use of the wealth of available data. Improvements in computer processing power and algorithm development have positioned machine learning, a branch of artificial intelligence, to play a prominent role in oncology research and practice. This review provides an overview of the basics of machine learning and highlights current progress and challenges in applying this technology to cancer diagnosis, prognosis, and treatment recommendations, including a discussion of current takeaways for clinicians.


2017 ◽  
Vol 107 (5) ◽  
pp. 476-480 ◽  
Author(s):  
Sendhil Mullainathan ◽  
Ziad Obermeyer

Machine learning tools are beginning to be deployed en masse in health care. While the statistical underpinnings of these techniques have been questioned with regard to causality and stability, we highlight a different concern here, relating to measurement issues. A characteristic feature of health data, unlike other applications of machine learning, is that neither y nor x is measured perfectly. Far from a minor nuance, this can undermine the power of machine learning algorithms to drive change in the health care system--and indeed, can cause them to reproduce and even magnify existing errors in human judgment.


2020 ◽  
Author(s):  
Glen Cheng ◽  
Nischal Chennuru ◽  
Liz Kwo

This chapter will introduce the clinician to the quickly expanding field of musculoskeletal-focused digital apps (MDA), with an eye towards helping the clinician select and recommend MDAs for optimal patient care. MDAs are increasingly being used for physical therapy and rehabilitation, telehealth, pain management, behavioral health, and remote patient monitoring. The COVID-19 pandemic has vastly accelerated the adoption of telehealth and digital health apps by patients and clinicians, and the digital health field will only continue to expand as developers increasingly harness artificial intelligence (AI) and machine learning (ML) capabilities, coupled with precision medicine capabilities that integrate personal health data tracking and genomics insights. Here we begin with an overview of several types of MDA, before discussing the epidemiology of musculoskeletal conditions and injuries, clinical considerations in selecting a digital health solution, payor reimbursement for digital apps, and regulatory oversight of digital health apps.


2019 ◽  
Vol 21 (3) ◽  
pp. 280-290 ◽  
Author(s):  
Jenifer Sunrise Winter ◽  
Elizabeth Davidson

Purpose This paper aims to assess the increasing challenges to governing the personal health information (PHI) essential for advancing artificial intelligence (AI) machine learning innovations in health care. Risks to privacy and justice/equity are discussed, along with potential solutions. Design/methodology/approach This conceptual paper highlights the scale and scope of PHI data consumed by deep learning algorithms and their opacity as novel challenges to health data governance. Findings This paper argues that these characteristics of machine learning will overwhelm existing data governance approaches such as privacy regulation and informed consent. Enhanced governance techniques and tools will be required to help preserve the autonomy and rights of individuals to control their PHI. Debate among all stakeholders and informed critique of how, and for whom, PHI-fueled health AI are developed and deployed are needed to channel these innovations in societally beneficial directions. Social implications Health data may be used to address pressing societal concerns, such as operational and system-level improvement, and innovations such as personalized medicine. This paper informs work seeking to harness these resources for societal good amidst many competing value claims and substantial risks for privacy and security. Originality/value This is the first paper focusing on health data governance in relation to AI/machine learning.


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