Abstract

The COVID-19 crisis has exposed some of the most pressing challenges affecting healthcare and highlighted the benefits that robust integration of digital and AI technologies in the healthcare setting may bring. Although medical solutions based on AI are growing rapidly, regulatory issues and policy initiatives including ownership and control of data, data sharing, privacy protection, telemedicine, and accountability need to be carefully and continually addressed as AI research requires robust and ethical guidelines, demanding an update of the legal and regulatory framework all over the world. Several recently proposed regulatory frameworks provide a solid foundation but do not address a number of issues that may prevent algorithms from being fully trusted. A global effort is needed for an open, mature conversation about the best possible way to guard against and mitigate possible harms to realize the potential of AI across health systems in a respectful and ethical way. This conversation must include national and international policymakers, physicians, digital health and machine learning leaders from industry and academia. If this is done properly and in a timely fashion, the potential of AI in healthcare will be realized.

Highlights

  • The new frontiers of research made possible by artificial intelligence (AI) algorithms based on machine learning (ML) and deep learning (DL) give the technological possibility of using aggregated healthcare data to produce models that enable a true precision approach to medicine [3,4,5,6,7,8]

  • During the first months of 2020, chest computedtomography scans showed the extent of lung damage caused by COVID-19; efforts were established around the world to facilitate data sharing, model training, and scan assessment [10,15]

  • Push Doctor, a company in the United Kingdom (U.K.) that has partnered with the National Health System (NHS), claimed in March that usage of their product had increased by 70% [19]

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Summary

Regulatory Issues and Policy Initiatives

In the last few years, governments have started to promote data sharing [36]. For instance, anonymized benchmarking datasets with annotated diagnoses have been created to provide reference standards [37,38]. Existing examples of data-sharing efforts include biobanks and international consortia for medical imaging databases, such as the Cancer Imaging Archive (TCIA) [39], the Visual Concept Extraction Challenge in Radiology Project [40], the Cardiac Atlas Project [41], the U.K. Biobank [42], and the Kaggle Data Science Bowl [25], the latter of which represents a valuable step in the direction of an openaccess database of anonymized medical images coupled with histology, clinical history, and genomic signatures. Biobank [42], and the Kaggle Data Science Bowl [25], the latter of which represents a valuable step in the direction of an openaccess database of anonymized medical images coupled with histology, clinical history, and genomic signatures Despite those hopeful examples, the amount of data sharing required for widespread adoption of AI technologies across different health systems demands still more efforts.

Legal and Regulatory Framework in EU
Legal and Regulatory Framework in China
Legal and Regulatory Framework in the Russian Federation
Ownership and Control of the Data
The Problem of Anonymization
Data Protection and Cybersecurity Implications
Accountability and Liability
Findings
Conclusions
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