News & Analysis as of

Hackers Data Breach Food and Drug Administration (FDA)

Mintz - Health Care Viewpoints

OCR Proposes Sweeping HIPAA Security Rule Amendments

Last fall at the Safeguarding Health Information: Building Assurance Through HIPAA Security 2024 conference, U.S. Department of Health & Human Services Office for Civil Rights (OCR) promised that before year’s end, it would...more

Faegre Drinker Biddle & Reath LLP

The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - Issue 3, August 2020

The Editors' Note - Welcome to the third issue of Decoded, Spilman's e-newsletter focusing on technology law, including data security, privacy standards, financing technologies, and digital-based means of conducting...more

Holland & Knight LLP

Impact of the New Health Industry Cybersecurity Practices: 2019 Outlook

Holland & Knight LLP on

• The U.S. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - October 2018

Robinson & Cole LLP on

On October 1, 2018, the Food and Drug Administration (FDA) issued its “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” to address continued threats to medical devices that could affect...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - July 2018 #2

Robinson & Cole LLP on

We have previously reported on the ongoing cybersecurity issues with St. Jude defibrillators [view related posts here, here, and here]. On June 29, 2018, the Food and Drug Administration (FDA) classified the required firmware...more

Searcy Denney Scarola Barnhart & Shipley

Hacking Gains New Heights with Threat to Big Pharma

Cyber attacks have broken free from their initial molds of carting off with consumer credit card numbers or stealing someone’s identity. The act of digitally digging into cyberspace has hit the U.S. Department of Health &...more

Polsinelli

Mobile Health Devices and Cybersecurity: Federal Guidance for Management of Threats in Medical Devices

Polsinelli on

New Technology = New Threats - With new technology comes new security concerns. But when that new technology is in the medical field, the cybersecurity vulnerabilities can be particularly devastating. The...more

JD Supra Perspectives

Hacking Your Health: For Healthcare Providers, Risk Analysis Must Be Ongoing

JD Supra Perspectives on

Healthcare providers would be wise to keep in mind that if a patient is harmed by a hacked medical device, Exhibit A in the negligence suit against them may be that provider’s risk analysis, or lack thereof....more

Robinson+Cole Data Privacy + Security Insider

FDA issues first medical device hacking alert

Reportedly for the first time ever, the FDA recently issued a declaration that hospitals should not use a medical device manufactured by Hospira Inc. because of security flaws that could allow hackers to penetrate hospital...more

Patrick Malone & Associates P.C. | DC Injury...

FDA Issues Alert on Preventing Medical Device Hacking

A couple of years ago, we wrote about the vulnerability of certain insulin pumps to outside hackers. Since then, many more many medical devices with embedded computer systems also seem to be vulnerable to cyber security...more

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