US Blood Pressure Validated Device Listing
US Blood Pressure Validated Device Listing
Blood pressure measurement devices that have been validated for clinical accuracy as determined through an independent review process.
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High blood pressure (BP) that is uncontrolled is the major cause of mortality and disability. For the diagnosis and treatment of hypertension, reliable blood pressure measurement is critical. If the BP measurement instrument has been validated for clinical accuracy, that is a crucial aspect of correct measurement.
Adapting FDA Regulation for AI and ML in Medical Devices
A Proposed Framework for Safety and Innovation
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The FDA is exploring how to regulate medical devices that incorporate artificial intelligence (AI) and machine learning (ML), acknowledging that their traditional regulatory framework is not fully equipped for the adaptive nature of these technologies. Traditionally, the FDA regulates medical devices through pathways like premarket clearance (510(k)), De Novo classification, or premarket...
What to consider if you shared your DNA data
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Genetic profiling company 23andMe is currently investigating a data scraping incident where private user information was stolen from its website. The confirmation came five days after an...
The Implications and Risks of Unauthorized DNA Data Access
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As DNA testing becomes more commonplace, the information it reveals — from our ancestral roots to health predispositions — becomes a tantalizing target for malicious actors. Beyond the...
With an October 2023 update due to the 23andMe breach
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The internet has made DNA testing a big global business. In the United States and Europe, millions of people have sent samples of their saliva to commercial labs in the hopes of learning something...
Medtronic reported a cybersecurity breach in its Paceart Optima System
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The Cybersecurity and Infrastructure Security Agency (CISA) has announced that Medtronic identified a cybersecurity vulnerability in its Paceart Optima System, a platform that manages cardiac...
Managing privacy, security, and safety as your health information technologies decline
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In the field of archival science, the term 'inherent vice' refers to the internal qualities or elements of certain objects that make them naturally prone to deterioration, regardless of...
With an update from the FTC on a pregnancy app that shared users’ sensitive information
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Abstract from the article titled, "Before Using Birth Control Apps Consider Your Privacy" posted on Wired.com: "Natural Cycles’ privacy policy states that in using...
A new Senate bill introduced in early April 2022 (including legislation in the House) would require medical device developers to be more accountable for the cybersecurity of their products.
Sens. Tammy Baldwin, D-Wisconsin, and Dr. Bill Cassidy, R-Louisiana, have introduced the bipartisan...
According to a survey from The Pew Charitable Trusts, 81%t of adults surveyed favor improved patient and provider access to health information. More than two-thirds of consumers want their clinicians to share health information that isn't presently required by federal data-sharing policies...
Medical devices with networking capabilities are critical technologies in patient care today. This article explains what their potential security vulnerabilities mean for the average consumer.
An article posted in the Journal of the American Medical Association identified that some of the highest-ranking health apps used to assist people with mental health conditions (e.g. depression) and smoking cessation were sharing data with Facebook and Google services and that only a third...