The U.S. Food and Drug Administration (FDA) recently released “A Working Model v.1.0” for its Software Precertification Program, which is aimed at organizations that design, test and monitor software products used for medical purposes (“Software as Medical Device” or “SaMD” products). The goal of the Software Precertification Program is to encourage innovation in digital health technologies by streamlining regulatory approaches while ensuring patient safety and device effectiveness.
The U.S. Food and Drug Administration (FDA) is increasing its capability to harness the power of big data – or more specifically of the “real world evidence” (RWE) – to assess the safety of medical products that are approved for the U.S. market. To that end, FDA is expanding its Sentinel System so that by the end of 2023 it would represent “a transformative, multi-purpose national data and scientific resource center for evidence generation that a wide array of stakeholders use to inform all aspects of healthcare decision making,” according to the recently released Sentinel System Five-Year Strategy.
Recently, the MITRE Corporation, in collaboration with the U.S. Food and Drug Administration (FDA), announced the release of the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. The Playbook was designed to provide “tools, references, and resources” for Healthcare Delivery Organizations (HDOs) to better prepare for and respond to medical device cybersecurity incidents.
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.
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.
The U.S. Food and Drug Administration has approved the country’s first drug with a digital ingestion tracking system.
Abilify MyCite is a pill that digitally tracks whether patients have taken the medication. The pill contains a sensor that, once ingested, sends a message to a patient’s wearable patch, which then transmits the information to a smartphone application. This voluntary process allows patients, caregivers, and physicians to track this information through a web-based portal if the patient has given consent. Experts believe that such digital devices could have a positive impact on public health by addressing a longstanding problem; in this case, that patients do not take their medicines as prescribed.