Artificial Intelligence (AI) can be employed in a health care setting for a variety of tasks, from managing electronic health records at a hospital, to market research at a benefits management organization, to optimizing manufacturing operations at a pharmaceutical company. The level of regulatory scrutiny of such systems depends on their intended use and associated risks.
In the U.S., for medical devices using AI, one of the key regulatory bodies is the Food and Drug Administration (FDA), especially its Center for Devices and Radiological Health (CDRH). CDRH has long followed a risk-based approach in its regulatory policies, and has officially recognized ISO Standard 14971 “Application of Risk Management to Medical Devices.” That standard is over 10 years old now, and therefore is currently undergoing revisions – some of which are meant to address challenges posed by AI and other digital tools that are flooding the medical-devices arena.
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On February 13, 2018 FDA approved a software application with clinical-decision support capability, in this case alerting providers of a potential stroke in patients. The system, “Viz.AI Contact,” is developed by a US/Israeli company named Viz.ai, which uses artificial intelligence and machine deep learning for analyzing medical images. Earlier in January, this system also received a CE Mark from the European authorities.
Stroke is caused by an interrupted blood supply to the brain; for example, due to a blood vessel’s rupture. Stroke is among leading causes of mortality and long-term disability in the U.S. and other countries. The Viz.AI Contact system analyzes brain computed tomography (CT) scans, identifies a suspected large vessel blockage, and sends a text notification to the health care specialist.
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The Partnership for Public Service has issued a report that examines how artificial intelligence (AI) is being used by federal and state authorities in a variety of areas.
The research for the report, “The Future Has Begun: Using Artificial Intelligence to Transform Government,” was performed in collaboration with the IBM Center for The Business of Government and includes four case studies. The first case study involved using AI techniques originally created at the University of South Carolina to fight crime more effectively. The software was originally used to fight domestic terrorism by helping federal and state officials determine potential targets and make recommendations on randomizing patrol routes, security schedules for police officers, boat patrol routes, and assigning air marshals to flights. In a later application of the same software, the same system was given to wildlife rangers in Africa to assist in making decisions on which wildlife areas to patrol on any given day to protect both animals and plants. This was in response to presidential Executive Order 13648 issued in 2013 to have the Agriculture, Treasury and State Departments assist in combating wildlife crime.
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