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
    risky jobs for lungs
    These Are the 10 Riskiest Jobs for Your Lungs
    November 15, 2022
    house cleaning tips to stay healthy this year
    Crucial House Cleaning Tips to Stay Healthy This Winter
    December 20, 2022
    Treating accidental Spinal Cord Injuries with Technology
    Treating Accidental Spinal Cord Injuries with Technology
    February 28, 2023
    Latest News
    5 Steps to a Promising Career as a Healthcare Administrator
    August 3, 2025
    Why Custom Telemedicine Apps Outperform Off‑the‑Shelf Solutions
    July 20, 2025
    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
  • 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
    The Flu Vaccine: Pros and Cons
    February 10, 2012
    SCOTUS Rules on a Couple of Important Pharma Cases
    June 27, 2011
    Weekend Athlete: Should You Have Sex Friday Night?
    March 8, 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: On Shoshin and Software Security
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 > Technology > On Shoshin and Software Security
Technology

On Shoshin and Software Security

Danny Lieberman
Danny Lieberman
Share
8 Min Read
SHARE

I am an independent software security consultant specializing in medical device security and HIPAA compliance in Israel.  There are over 700 medical device companies in Israel – all doing totally cool and innovative things from My Dario (diabetes management) to Syneron (medical esthetics).

Contents
Medical device security is an adversarial environment very unlike FDA regulatory oversight.Medical device security is about attackers and totally unpredictable behaviorWinning friends and influencing client in the threat analysis

I am an independent software security consultant specializing in medical device security and HIPAA compliance in Israel.  There are over 700 medical device companies in Israel – all doing totally cool and innovative things from My Dario (diabetes management) to Syneron (medical esthetics).

This is a great niche for me because I get to do totally cool projects and  work with a lot of really smart people at Israeli medical device vendors helping them implement cost-effective  security and privacy compliance + it’s fun learning all the time.

One of my insights is that there is very little connection between and FDA medical device risk assessment and a software security risk assessment.   This somewhat counter-intuitive for people who believe in risk management as in banks and insurance companies and law.

More Read

Image
The Growing Trend of Automation in Healthcare
Bay Area Surgical Management Discusses Innovative Healthcare Advancements
Here’s How Technological Innovation Is Transforming Healthcare
5 More Must-Know Emerging Health Technology Trends for Healthcare Innovators
All You Need To Know About Patient Portals

Medical device security is an adversarial environment very unlike FDA regulatory oversight.

FDA medical device regulatory oversight is about complying in a reliable way with standard operating procedures and 20 year old software standards.   Software security is about mitigating the unexpected in a reliable way.

FDA believes that conformance with this guidance document, when combined with the general controls of the Act, will provide reasonable assurance of the safety and effectiveness…

FDA recognizes several software consensus standards. A declaration of conformity to these standards, in part or whole, may be used to show the manufacturer has verified and validated pertinent specifications of the design controls. The consensus standards are:

  • ISO/IEC 12207:1995 Information Technology – Software Life Cycle Processes
  • IEEE/EIA 12207.O-1996 Industry Implementation of International Standard ISO/IEC12207:1995 (ISO/IEC 12207) Standard for Information Technology – Software Life Cycle Processes

Medical device security is about attackers and totally unpredictable behavior

Medical device security is about anticipating  the weakest link in a system that can be exploited by an attacker who will do totally unpredictable things that were inconceivable last year by other hackers, let alone 20 years ago by an ISO standards body.

You cannot manage unpredictable behavior (think about a 2 year old) although you can develop the means for anticipating threats and responding quickly and in a focused way even when sleep-deprived and caffeine-enriched.

For a person like me (an independent security consultant with a graduate degree in physics and a high sense of self-worth), there is an overwhelming temptation to show clients how dangerous their security vulnerabilities are and how much you can add value to their product.

Winning friends and influencing client in the threat analysis

This is not however a strategy guaranteed to win friends and influence people (and win repeat business) – i.e. forcing the client to do the “right” things.

Instead of saying – “that is a really bad idea, and you will get hacked and destroy your reputation before your QA and RA departments get back from lunch“, I have realized that it is better to take a more nuanced approach like:

“I see that you are transferring credentials in plain-text to your server in the cloud.   What do you think about the implications of that?“.   Getting the customer to think like an attacker is better than dazzling and intimidating the client which has short-term ROI for your ego and poor probability of improving the clients’ medical device security.

How did I reach this amazing (slow drum roll…) insight?

About 3 years ago I read a book called Search Inside Yourself: The Unexpected Path to Achieving Success, Happiness (and World Peace) and I learned an idea from Zen Buddhism called – “Don’t take action, let action take you“.    I try to apply this approach with clients as a way of helping them learn themselves and as a way of avoiding unnecessary conflict.  The next step in my Zen Buddhist evolution was getting acquainted with another concept from called Shoshin:

Shoshin (初心) means “beginner’s mind”. It refers to having an attitude of openness, eagerness, and lack of preconceptions when studying a subject, even when studying at an advanced level, just as a beginner in that subject would.

For advanced medical device security consultant like me, this means doing the exact OPPOSITE of what you normally do in the course of a security threat assessment:

  1. Let go of the need to add value – you do not have to provide novel security countermeasures in your threat model all the time. Sometimes, doing the basics (like hashing and salting passwords) is all the value the client needs.
  2. Let go of the need to win every argument – you do not have to provide novel security countermeasures in your threat model and show the client why their RA (regulatory assurance) consultant are making fatal mistakes.
  3. Ask the client to tell you more – you can ask what led the client to a particular design decision.  You may learn something about their system design alternatives and engineering constraints. This will help you design novel security countermeasures for their medical device.
  4. Assume you are an idiot –  this is a corollary of not taking action.   By being neutral, and assuming you are an idiot, you disable your ego for a few moments and you get into a position of accepting new information  which may help you design novel security countermeasures for their medical device….

 

Thank you to James Clear for his insightful post – Shoshin: This Zen Concept Will Help You Stop Being a Slave to Old Behaviors and Beliefs and inspiring the application of Shoshin to medical device security threat modeling.

Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

technology in medical research
The Tools Helping Medical Researchers See the Full Picture
News Technology
August 3, 2025
5 Steps to a Promising Career as a Healthcare Administrator
5 Steps to a Promising Career as a Healthcare Administrator
Health
July 31, 2025
holistic dental
Holistic Dentist Services Are Natural and Safe
Dental health Specialties
July 28, 2025
botox certification
Help Improve People’s Skin Health Via Botox Certification
Skin Specialties
July 22, 2025

You Might also Like

Can Medical PDAs Revolutionize Battlefield Healthcare?

February 29, 2016
HIPAA Breach
eHealthMedical RecordsPolicy & LawSocial MediaTechnology

Social Media’s Effect on HIPAA Privacy and Security

September 6, 2013

Online Addiction: Types and Treatment

May 1, 2018
Medical Appointment
InfographicsMedical Innovations

The Lifecycle Of A Medical Appointment: Streamlining The Patient Journey

December 22, 2024
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?