By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    medicare part d benefits
    Everything that You Need to Know About Medicare Part D
    August 15, 2022
    Best Ways to Boost Your Immune System this Winter
    Best Ways to Boost Your Immune System this Winter
    November 15, 2022
    back pain issues
    Ways to Treat Constant Back Pain
    August 21, 2023
    Latest News
    How Probate Planning Shapes the Future of Your Estate and Family Care
    July 17, 2025
    Beyond Nutrition: Everyday Foods That Support Whole-Body Health
    June 15, 2025
    The Wide-Ranging Benefits of Magnesium Supplements
    June 11, 2025
    The Best Home Remedies for Migraines
    June 5, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    More On Wellness Programs To Improve Health and Reduce Costs
    January 25, 2012
    Privatizing Social Security and Medicare: Who Can Defuse Political Dynamite?
    June 12, 2011
    Study: Risk of Death in Elderly Patients with Dementia Doubled with Some Antipsychotic Medications
    February 26, 2012
    Latest News
    How IT and Marketing Teams Can Collaborate to Protect Patient Trust
    July 17, 2025
    How Health Choices and Legal Actions Intersect After an Injury
    July 17, 2025
    How communities and healthcare providers can address slip and fall injuries with legal awareness
    July 17, 2025
    Let Your Lawyer Handle the Work Before You Pay Medical Costs
    July 6, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: FDA Issues Draft Guidance on Cybersecurity
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Policy & Law > FDA Issues Draft Guidance on Cybersecurity
Policy & Law

FDA Issues Draft Guidance on Cybersecurity

Tim Gee
Tim Gee
Share
7 Min Read
SHARE

The FDA sets manufacturer’s expectations on what is expected to address data security threats in medical devices.

This draft guidance (pdf download) applies to conventional embedded system medical devices with embedded software (firmware or programmable logic) and software products regulated as medical devices. Think about that for a few seconds and let the scope of impact become clear in your mind.

The FDA press release hits the high points. Perhaps the biggest is this statement (emphasis mine):

The FDA sets manufacturer’s expectations on what is expected to address data security threats in medical devices.

This draft guidance (pdf download) applies to conventional embedded system medical devices with embedded software (firmware or programmable logic) and software products regulated as medical devices. Think about that for a few seconds and let the scope of impact become clear in your mind.

The FDA press release hits the high points. Perhaps the biggest is this statement (emphasis mine):

More Read

Vaccines in the Developing World
The 7 Preventative Care Appointments You Should Make This Year
Seize the Moment for Patient-Centered Care
Can Crohn’s disease be cured?
PFCD 2011 Year in Review & Looking Ahead to 2012

For the majority of cases, actions taken by manufacturers to address cybersecurity vulnerabilities and exploits are considered “cybersecurity routine updates or patches,” for which the FDA does not require advance notification, additional premarket review or reporting under its regulations.

For many years, manufacturers have shrugged off implementing operating system and security patches — at all or in a timely fashion — because of FDA regulatory requirements. Of course, there are no such regulatory requirements precluding manufacturers from patching their systems, and it is interesting that FDA feels the need to reinforce this in their press release. This is important because FDA clearly states that data security remediation does not have to be reviewed or cleared by FDA — but manufacturers are still required to follow their Quality System. Based on this, I would not be surprised to see increased enforcement discretion regarding this guidance.

Here’s more (again, emphasis mine):

For a small subset of cybersecurity vulnerabilities and exploits that may compromise the essential clinical performance of a device and present a reasonable probability of serious adverse health consequences or death, the FDA would require medical device manufacturers to notify the agency.

This sounds almost like a recall scenario, perhaps even ship-holds by the manufacturer until the vulnerability is mitigated. There have been plenty of medical devices infected by malicious software in the past. The biggest impact to date has been the loss of the use of infected devices until their software is restored rather than patient safety impacts.

Speaking of notifications, the draft guidance does describe notifications to customers:

Section VII describes recommendations for remediating and reporting identified cybersecurity vulnerabilities, including the development, implementation and user notification concerning official fixes, temporary fixes, and work-arounds. Manufacturers should also adopt a coordinated vulnerability disclosure policy. FDA has recognized ISO/IEC 29147:2014: Information Technology – Security Techniques – Vulnerability Disclosure that may be a useful resource for manufacturers.

So customer notifications will be expected by the FDA are described in some detail, and a new standard is highlighted as a benchmark for future 510k submissions.

Another pretty big change is the “recommendation” for manufacturers to work together in some sort of multi-vendor alliance to manage the risks posed by malicious software to medical devices:

Today’s draft guidance outlines postmarket recommendations for medical device manufacturers, including […] the importance of information sharing via participation in an Information Sharing Analysis Organization (ISAO), a collaborative group in which public and private-sector members share cybersecurity information.

Will the HITRUST Alliance extend their franchise to include medical devices, will HIMSS jump in, will a new entity be formed for this purpose, or will this recommendation be ignored by industry?

After an initial quick review, an interesting question is whether a medical device with just a serial port, say a ventilator, should address cybersecurity. The manufacturer is not claiming any network connectivity, but customers are increasingly using third party software (an MDDS from Capsule, or a Bernoulli system) to integrate their ventilators to the enterprise network. Per the guidance, all medical devices with embedded software will be expected to follow this guidance.

A definite cybersecurity red flag is a medical device have a USB connector, regardless of an absence of networking claims.

Implications

FDA guidance are more than just recommendations. In a sense, they are defacto requirements, unless the manufacturer can provide justification as to why the recommendations should not apply to them or their product. Once a guidance is final, subsequent 510k submissions are evaluated with the expectation that relevant guidance will be incorporated in the filing. When expected guidance is not followed, the reviewer looks for suitable justification in the filing for not conforming to the guidance. Should suitable justification not be found (or accepted) the manufacturer will receive questions from the reviewer seeking either suitable justification or compliance with the guidance.

Manufacturers and software developers should start upping their data security game now. While it may take a year or more for the final guidance to be released, data security is not a trivial undertaking and industry should use this time between the draft and final guidance as an opportunity to get things squared away.

Changes like this are always less expensive when done in a considered manner over a reasonable period of time. Rushing things at the last minute to complete a 510k submission is more expensive and results in a less ideal outcome.

Love ’em or hate ’em, the FDA typically does a pretty good job of doing their homework. This draft guidance is another example of FDA taking a topic that’s relatively new to them and the industry, doing their homework, and developing a thoughtful approach to dealing with the issue. While I’m sure there will be some substantive feedback during the comment period, I would not count on this Guidance being drastically changed or watered down.

 

TAGGED:cyber securityFDAmedical devices
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
How IT and Marketing Teams Can Collaborate to Protect Patient Trust
Global Healthcare Policy & Law
July 17, 2025
paramedics in surgical gloves and masks
How Health Choices and Legal Actions Intersect After an Injury
Health care
July 16, 2025
a woman giving a key
How Probate Planning Shapes the Future of Your Estate and Family Care
Health
July 16, 2025
a woman with kinesio tapes on her back arm
How communities and healthcare providers can address slip and fall injuries with legal awareness
Health care
July 16, 2025

You Might also Like

accident injuries healthworkscollective
Global HealthcareHealth careNewsPolicy & Law

Beyond the Fender Bender: Accident Injuries, Actions, and Recovery

July 14, 2017

Consumer Health Revolution On the Horizon? Challenges for mHealth 2012

January 19, 2012

Healthization of Development

March 29, 2012
Image
Public Health

Person-Centered HealthCare: How to Stay Safe While at the Hospital

January 11, 2013
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?