Towards Regulatory-Compliant MLOps: Oravizio’s Journey from a Machine Learning Experiment to a Deployed Certified Medical Product

Peer reviewe

Characteristics of medical device software development

This paper aims to describe the software development settings of medical device domain focusing on the demands of the safety critical software processes. Medical device software developers have to adhere to a number of regulations and standards. This paper addresses the most important characteristics of a software development framework that could support medical device software developers in their efforts to comply with these regulations as well as to improve their software development processes

Piloting MDevSPICE: the medical device software process assessment framework

Software development companies moving into the medical device domain often find themselves overwhelmed by the number of regulatory requirements they need to satisfy before they can market their device. Several international standards and guidance documents have been developed to help companies on their road to regulatory compliance but working their way through the various standards is a challenge in itself. In order to help software companies in the medical device domain, we have developed an integrated framework of medical device software development best practices called MDevSPICE®. This framework integrates generic software development best practices with medical device standards’ requirements enabling consistent and thorough assessment of medical device processes. MDevSPICE® can be used by software companies evaluating their readiness for regulatory audits as well as by large medical device manufacturers for selecting suitable software suppliers. The MDevSPICE® framework consists of a process reference model, a process assessment model, an assessment method, and training and certification schemes. The framework has been validated using expert reviews and through MDevSPICE® assessments in industry. In this paper, we describe the MDevSPICE® process assessment framework focusing on its benefits and significance for the medical device manufacturing community as learned from MDevSPICE® assessments conducted to date

IMPLEMENTING ETHICS INTO ARTIFICIAL INTELLIGENCE: A CONTRIBUTION, FROM A LEGAL PERSPECTIVE, TO THE DEVELOPMENT OF AN AI GOVERNANCE REGIME

The increasing use of AI and autonomous systems will have revolutionary impacts on society. Despite many benefits, AI and autonomous systems involve considerable risks that need to be managed. Minimizing these risks will emphasize the respective benefits while at the same time protecting the ethical values defined by fundamental rights and basic constitutional principles, thereby preserving a human centric society. This Article advocates for the need to conduct in-depth risk-benefit-assessments with regard to the use of AI and autonomous systems. This Article points out major concerns in relation to AI and autonomous systems such as likely job losses, causation of damages, lack of transparency, increasing loss of humanity in social relationships, loss of privacy and personal autonomy, potential information biases and the error proneness, and susceptibility to manipulation of AI and autonomous systems

Is my medical software allowed to go to market?

The central importance of software in healthcare practices is highlighted by the increasing regulation of medical software in order to safeguard medical activities and patient’s rights. Medical software suppliers need to meet regulatory requirements from different countries to gain market access and offer necessary compliant solutions. The present report focuses on providing methods and tools to allow software suppliers to evaluate which software products should be sold in which countries. Using design science and behavioral science two artifacts are presented integrating influence of regulatory requirements on market access and product lifecycle management. It is required to present all the regulatory information in an actionable way in order for it to be operationalized by businesses and engineering staff within a company

Clinical risk prediction models: the canary in the coalmine for artificial intelligence in healthcare?

From Europe PMC via Jisc Publications RouterHistory: ppub 2021-10-01Publication status: Publishe

Physician attitudes towards-and adoption of-mobile health

OBJECTIVE: Smartphone apps and mobile devices are an emerging method of healthcare data collection. This study sought to understand how physicians currently view mobile health (mHealth) technologies and use them in patient care. METHODS: A total of 186 physicians affiliated with Washington University School of Medicine in St. Louis, Missouri, USA completed a survey in 2016 regarding their current implementation of mHealth technologies for patient care and support for further development. RESULTS: More than half of respondents were willing to discuss health apps and mobile devices with patients. However, most were not currently recommending them to patients. Apps/devices that encouraged a healthy diet and weight or tracked heart rate received the highest satisfaction ratings. Apps/devices that accessed the EMR (electronic medical record) remotely, provided medication reminders, or enrolled research subjects garnered the most interest despite respondents lacking prior experience. A majority agreed that collected biometrics are useful for promoting a healthy lifestyle (68%), tracking medical treatment (64%), or conducting research (56%); and agreed that proof of accuracy and precision (81%) and the efficient integration of collected data (68%) are necessary improvements. Uploading data automatically and updating physicians in real-time was the most preferred method of data integration into the EMR. CONCLUSIONS: Physicians show interest in using mHealth technologies for patient care but have limited experience, usually with those specific to their specialties. Proof of quality and a method to integrate data into the EMR are necessary for a mainstream role in healthcare