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Protected Health Information Data Security Medical Devices

Gardner Law

Navigating HIPAA and State Privacy Laws for Drug and Device Manufacturers

Gardner Law on

The Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 22, Number 9. Privacy Briefs: September 2022

Report on Patient Privacy 22, no. 9 (September, 2022) - More than 92% of patients believe privacy is a right and their health data should not be available for purchase, according to a survey from the American Medical...more

Spilman Thomas & Battle, PLLC

The PATCH Act: Protecting Medical Devices from Cyber Attacks

In a previous issue of Decoded, we discussed the alarming fact that many medical devices, including those implanted in patients' bodies, are leaving the manufacturers with known cybersecurity flaws. Due to these known flaws,...more

Health Care Compliance Association (HCCA)

Securing Problematic 'Legacy' Devices: Be Part of Procurement, Push for Info

Report on Patient Privacy 22, no. 3 (March, 2022) - Typically a “legacy” describes the lasting impact of an influential person or movement, most often in a positive sense. Not so with medical devices. When legacy is applied...more

Health Care Compliance Association (HCCA)

2022 Outlook: More Dangerous Ransomware Coupled With Inadequate Security Practices

Report on Patient Privacy 22, no. 1 (January, 2022) - As the COVID-19 pandemic enters its third year, real “security fatigue” with pandemic-related issues will combine with cybercriminals’ increasingly sophisticated...more

Reveal

There Are More Challenges in Managing Discovery in Healthcare Than You Probably Realize

Reveal on

A few months ago on this blog, I wrote about using Artificial Intelligence (AI) to keep up with the “alphabet soup” of compliance. An important area to address from a compliance standpoint is health data and at least two of...more

BakerHostetler

Life Sciences: Connected Medical Devices in the Cloud During COVID-19

BakerHostetler on

The Pandemic has fast-tracked the use of telehealth services. Hussein Akhavannik discusses how medical device companies are looking to add to or expand remote monitoring capabilities. However, some capabilities raise legal...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

Shook, Hardy & Bacon L.L.P.

Emerging Trends In Surgical Robotics Product Liability Litigation

Over the last decade, robotics have revolutionized healthcare. Surgical robots are rapidly making their way into many of our nation’s operating rooms, and are being used in a wide variety of surgeries ranging from...more

Perkins Coie

Commission Holds FTC Unfairness Claim Does Not Require “Probable” or Tangible Injury in LabMD Data Security Case

Perkins Coie on

The Federal Trade Commission unanimously (3-0) ruled on July 29, 2016 that LabMD’s data security practices were “unfair” under Section 5 of the FTC Act, reversing a decision of its Administrative Law Judge (ALJ). As we...more

Morgan Lewis

International Life Sciences Data Transfers After Schrems

Morgan Lewis on

With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....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

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