Tag: FDA

New Handbook Provides Guidance to Healthcare Delivery Organizations on Preparation and Response to Medical Device Cybersecurity Incidents

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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.

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US FDA Approaches to Artificial Intelligence

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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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FDA Approves Software Application That Alerts Providers of Potential Stroke in Patients

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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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FDA Approves First Digital Pill

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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.

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New FDA Guidance on Waiver of Informed Consent for Minimal Risk Investigations

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The FDA recently issued new guidance that allows institutional review boards (IRBs) to waive or alter the FDA’s informed consent requirements for certain minimal risk clinical investigations without objection from the FDA.

The statutory basis for the guidance comes from amendments made by the 21st Century Cures Act from late in 2016 (P.L 144-255). This guidance, which took effect on July 25, 2017, is the first step for the FDA on this issue.  The FDA intends to implement subsequent regulations to permit IRB waiver or alterations of informed consent requirements for minimal risk clinical investigations.

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