Medical Device Legal News with Sam Bernstein: Episode 10

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A mobile application developer of ovulation and period tracking software agrees to pay civil penalties and 20 years of independent monitoring for violating the Health Breach Notification Rule for sharing sensitive personal health information without consumer notice or consent; A physician is sentenced to 25 years in prison for reusing single-use devices on patients in more than 1500 procedures; the FDA releases final guidance regarding the content of premarket submissions for device software functions, among other topics.
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