News & Analysis as of

Internet of Things Medical Devices

Hogan Lovells

EU Data Act Series (part 3): medical and health devices and data sharing obligations

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The Data Act Proposal envisages the rights of users of medical devices / health wearables to have access to and to share the data originated from the use of the device with third parties. These access and sharing rights are...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

Robinson+Cole Data Privacy + Security Insider

FBI Issues Notice to Health Industry Highlighting Risks of Unpatched Medical Devices

The FBI issued a Private Industry Notification targeted to the health care sector on September 12, 2022, warning that it has “identified an increasing number of vulnerabilities posed by unpatched medical devices that run on...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

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 3, Issue 5

The Cryptocurrency Revolution and President Biden's Formal Recognition - Out of the ashes of the 2008 financial crisis, Bitcoin sprang up like an insurgency, targeting both the unbridled activity of large financial...more

Robinson+Cole Data Privacy + Security Insider

Health Care IoT Devices Pose Risk to Patient Care

As if health care entities don’t have enough to worry about  during this chaotic and difficult time in the pandemic, a new report released by Cynerio, entitled “The State of IoMT Device Security 2022,” provides a list of...more

Faegre Drinker Biddle & Reath LLP

Smart Medical Devices Open New Treatment and Litigation Doors While Confirming Age-Old Balancing Acts

Telemedicine and telehealth have significantly reshaped how consumers access health care services. Even before the COVID-19 pandemic, online portals were jockeying to replace visits to primary care providers and urgent care...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

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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

Bass, Berry & Sims PLC

Medical Device Dealmaker Perspectives Takeaways

Bass, Berry & Sims PLC on

Bass, Berry & Sims recently presented the latest in its Dealmaker Perspectives series on the medical device industry. Ryan Thomas, Member of Bass, Berry & Sims and Co-Chair, Healthcare Private Equity Team, and Frank...more

Akin Gump Strauss Hauer & Feld LLP

FDA Appoints Acting Director of Medical Device Security, Signaling Increased Commitment to Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) announced that the newly-created post of Acting Director of Medical Device Security has been filled by Kevin Fu, a University of Michigan associate professor and founder of the...more

Porter Hedges LLP

Patent Litigation Considerations For The Internet Of Medical Things (IoMT) COVID-19 Boom

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The COVID-19 pandemic has been a catalyst for medical technology innovation, especially the Internet of Medical Things (IoMT). IoMT generally refers to the use of network and cloud technologies to connect medical equipment...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Patent Prosecution Tool Kit: Medical Device Considerations

Preparing and prosecuting medical device patents can be unique and challenging. Patent owners and practitioners often must consider a wide range of converging technologies from the mechanical, electrical, chemical, and...more

Nutter McClennen & Fish LLP

Code Blue: Cybersecurity Vulnerabilities for Medical Device Makers Require Urgent Care

Q: How is the shift of medical devices moving to the Internet of Things affecting the health care industry? A: Connected medical devices routinely record sensitive health information about a patient. This critical...more

Faegre Drinker Biddle & Reath LLP

As the Popularity of Health Care IoT Rises, So Do Privacy and Security Risks

Internet-connected medical devices are nothing new. From x-ray machines to infusion pumps, these devices have helped push major advancements in clinical care. Increasingly, we see health care technology moving out of...more

Hogan Lovells

[Webinar] Health Care and the Internet of Things: New Regulatory Developments - July 25th, 2:00pm EDT

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Please join the Hogan Lovells Communications and FDA practices on Thursday, July 25th for our webinar, Health Care and the Internet of Things: New Regulatory Developments. We will explore new policy initiatives and...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - July 2019

Robinson & Cole LLP on

DHS Warns Businesses of Risk of Iranian-Backed Wiper Malware Attacks - The tension with Iran has generally increased, and it has been reported that the U.S. has launched a cyber-attack against Iran. In retaliation, the risk...more

Robinson+Cole Data Privacy + Security Insider

Privacy Tip #190 – Internet of Medical Things (IoMT)

These days, pretty much everyone is aware of potential security incidents and the risks involved with Internet of Things (IoT) devices because security was not built into the device during the manufacturing process, but there...more

Jones Day

The FDA and Cybersecurity: How the Agency is Addressing Cybersecurity Risks to Medical Devices

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The Situation: As medical devices become more connected to each other and to the internet, an increasing number of patients are exposed to cybersecurity risks. The Result: Over the last five years, the Food and Drug...more

Burns & Levinson LLP

California Enacts First U.S. Law Requiring IoT Cybersecurity

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“Smart” devices have become common, if not pervasive, experiences of daily life. Parents may monitor a baby’s heart rate and oxygen levels through sensor enabled baby socks. Businesses may equip fleet drivers with smart...more

White and Williams LLP

HHS Issues Voluntary Cybersecurity Guidelines for the Healthcare Industry

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On December 28, 2018, the U.S. Department of Health and Human Services (HHS) released “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients,” a detailed set of voluntary guidelines illustrating...more

White and Williams LLP

OIG Recommendations to the FDA for Medical Device Cybersecurity: Foretelling Additional Regulation and Requirements for Controls?

White and Williams LLP on

With more and more medical devices connected to the Internet of Things (IoT), there is increasing concern over the potential vulnerabilities for cyberattacks against such devices. This vulnerability represents not only...more

Knobbe Martens

Medical Device Market Returns and Recent Industry Activity

Knobbe Martens on

The medical device and related markets have shown some growth recently. For example, IHI, an iShares U.S. Medical Devices ETF, has a total return of about 24% year-to-date in 2018. In the same time period, the S&P 500 has...more

Hogan Lovells

Best practices for managing cybersecurity risks related to IoT-connected medical devices

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Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their...more

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