Tag Archives: medical devices

Anatonme – a hand held device for improving patient-doctor communications

From a recent article in Healthcare Global.

Studies suggest that 30-50 percent of patients are likely to give up treatments early.  Microsoft Research has developed an innovative, hand-held medical device called Anatonme to help patients understand their issue and complete their treatment plan more often.

We’ve been doing research and development into private, controlled social networking to reinforce private communications between doctor and patient. It’s gratifying to see Microsoft Research doing work in this area.

Private social networking for doctors and patients provides highly effective secure data sharing between doctors and patients. It allows patient-mediated input of data before visits to the office, making the clinical data more accurate and complete and boosting the trust between doctor/healthcare worker and patient.

A private social network has a controlled 1 to N (doctor to patients) topology and physiological and emotional context, unlike Facebook that has a distracting social graph and entertainment context.

A private social network for doctors and patients also provides powerful information exchange and search:

  1. Capture critical events on a timeline (for example blood pressure, dizziness etc) that enables the doctor to respond in a timely fashion.
  2. Reconciles differences between what the doctor ordered and what the patient did.
  3. Granular access control for sharing of data between doctor, patient and referrals.

If you’re interested in hearing more – contact us.

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Beyond the firewall

Beyond the firewall – data loss prevention

What a simple idea. It doesn’t matter how they break into your network or servers – if attackers can’t take out your data, then you’ve mitigated the threat.

Data loss prevention is a category of information security products that has matured from Web / email content filtering products into technologies that can detect unauthorized network transfer of valuable digital assets such as credit cards. This paper reviews the motivation for and the taxonomies of advanced content flow monitoring technologies that are being used to audit network activity and protect data inside the network.

Motivation – why prevent data loss?

The majority of hacker attacks and data loss events are not on the IT infrastructure but on the data itself.  If you have valuable data (credit cards, customer lists, ePHI) then you have to protect it.

Content monitoring has traditionally meant monitoring of employee or student surfing and filtering out objective content such as violence, pornography and drugs. This sort of Web content filtering became “mainstream” with wide-scale deployments in schools and larger businesses by commercial closed source companies such as McAfee and Bluecoat and Open Source products such as Censor Net and Spam Assassin. Similar signature-based technologies are also used to perform intrusion detection and prevention.

However, starting in 2003, a new class of content monitoring products started emerging that is aimed squarely at protecting firms from unauthorized “information leakage”, “data theft” or “data loss” no matter what kind of attack was mounted. Whether the data was stolen by hackers, leaked by malicious insiders or disclosed via a Web application vulnerability, the data is flowing out of the organization. The attack vector in a data loss event is immaterial if we focus on preventing the data loss itself.

The motivation for using data loss prevention products is economic not behavioral; transfer of digital assets  such as credit cards and PHI by trusted insiders or trusted systems can cause much more economic damage than viruses to a business.

Unlike viruses, once a competitor steals data you cannot reformat the hard disk and restore from backup.

Companies often hesitate from publicly reporting data loss events because it damages their corporate brand, gives competitors an advantage and undermines customer trust no matter how much economic damage was actually done.

Who buys DLP (data loss prevention)?

This is an interesting question. On one hand, we understand that protecting intellectual property, commercial assets and compliance-regulated data like ePHI and credit cards is  essentially an issue of  business risk management. On the other hand, companies like Symantec and McAfee and IBM sell security products to IT and information security managers.

IT managers focus on maintaining predictable execution of business processes not dealing with unpredictable, rare, high-impact events like data loss.  Information security managers find DLP technology interesting (and even titillating – since it detects details of employee behavior, good and bad) but an  information security manager who buys Data loss prevention (DLP) technology is essentially admitting that his perimeter security (firewall, IPS) and policies and procedures are inadequate.

While data loss prevention may be a problematic sale for IT and information security staffers, it plays well into the overall risk analysis,  risk management and compliance processes of the business unit.

Data loss prevention for senior executives

There seem to be three schools of thought on this with senior executives:

  1. One common approach is to ignore the problem and brush it under the compliance carpet using a line of reasoning that says “If I’m PCI DSS/HIPAA compliant, then I’ve done what needs to be done, and there is no point spending more money on fancy security technologies that will expose even more vulnerabilities”.
  2. A second approach is to perform passive data loss detection and monitor flow of data(like email and file transfers) without notifying employees or the whole world. Anomalous detection events can then be used to improve business processes and mitigate system vulnerabilities. The advantage of passive monitoring is that neither employees nor hackers can detect a Layer 2 sniffer device and a sniffer is immune to configuration and operational problems in the network. If it can’t be detected on the network. then this school of thought has plausible deniability.
  3. A third approach takes data loss prevention a step beyond security and turns it into a competitive advantage. A smart CEO can use data loss prevention system as a deterrent and as a way of enhancing the brand (“your credit cards are safer with us because even if the Saudi hacker gets past our firewall and into the network, he won’t be able to take the data out”).

A firewall is not enough

Many firms now realize that a firewall is not enough to protect digital assets inside the network and look towards incoming/outgoing content monitoring. This is because: 

  1. The firewall might not be properly configured to stop all the suspicious traffic.

  2. The firewall doesn’t have the capability to detect all types of content, especially embedded content in tunneled protocols.

  3. The major of hacker attacks and data loss events are not on the IT infrastructure but on the data itself.

  4. Most hackers do not expect creative defenses so they assume that once they are in, nobody is watching their nasty activities.

  5. The firewall itself can be compromised. As we have more and more Day-0 attacks and trusted insider threats, so it is good practice to add additional independent controls.


Sophisticated incoming and outgoing (data loss prevention or DLP) content monitoring technologies basically use three paradigms for detecting security events

  1. AD- Anomaly Detection – describes normal network behavior and flags everything else
  2. MD- Misuse Detection – describes attacks and flags them directly
  3. BA – Burglar alarm – describes abnormal network behavior (“detection by exception”)

In anomaly detection, new traffic that doesn’t match the model is labeled as suspicious or bad and an alert is generated. The main limitation of anomaly detection is that if it is too conservative, then it will generate too many false positives (a false alarm) and over time the analyst will ignore it. On the other hand, if a tool rapidly adapts the model to evolving traffic change, then too little alerts will be generated and the analyst will again ignore it.

Misuse detection describes attacks and flags them directly, using a database of known attack signatures and constantly tries to match the actual traffic against the database. If there is a match, an alert is generated. The database typically contains rules for:

  1. Protocol Stack Verification – RFC’s, ping of death, stealth scanning etc.
  2. Application Protocol Verification – WinNuke , invalid packets that cause DNS cache corruption etc.
  3. Application Misuse – misuse that causes applications to crash or enables a user to gain super user privileges; typically due to buffer overflows or due to implementation bugs.
  4. Intruder detection. Known attacks can be recognized by the effects caused by the attack itself. For example, Back Orifice 2000 sends traffic on default port is 31337
  5. Data loss detection – for example by file types, compound regular expressions, linguistic and/or statistical content profiling. Data loss prevention or detection needs to work at a much higher level than intrusion detection – since it needs to understand file formats and analyze the actual content such as Microsoft Office attachments in a Web mail session as opposed to doing simple pattern matching of an http request string.

Using a burglar alarm model, the analyst needs deep understanding of the network and what should not happen with it. He builds rules that model how the monitored network should conceptually work, in order to generate alerts when suspicious traffic is detected. The richer the rules database, the more effective the tool. The advantage of the burglar alarm model is that a good network administrator can leverage his knowledge of servers, segments and clients (for example a Siebel CRM server which is a client to a Oracle database server) in order to focus-in and manage-by-exception.

What about prevention?

Anomaly detection is an excellent way of identifying network vulnerabilities but a customer cannot prevent extrusion events based on general network anomalies such as usage of anonymous ftp. In comparison there is a conceptual problem with misuse detection. If misuse is detected then unless the event can be prevented (either internally with a TCP reset, by notifying the router or firewall) – then the usefulness of the devices is limited to forensics collection.

What about security management?

SIM – or security information management consolidates reporting, analysis, event management and log analysis. There are a number of tools in this category – Netforensics is one. SIM systems do not perform detection or prevention functions – they manage and receive reports from other systems. Checkpoint for example is a vendor that provides this functionality with partnerships.


There are many novel DLP/data loss prevention products, most provide capabilities far ahead of both business and IT infrastructure management that are only now beginning to look towards content monitoring behind the firewall.

DLP (Data loss prevention) solutions join an array of content and application-security products around the traditional firewall. Customers are already implementing a multitude of network security products for Inbound Web filtering, Anti-virus, Inbound mail filtering and Instant Messaging enforcement along with products for SIM and integrated log analysis.

The industry has reached the point where the need to simplify and reduce IT security implementation and operational costs becomes a major purchasing driver, perhaps more dominant than any single best-of-breed product.

Perhaps data loss prevention needs to become a network security function that is part of the network switching fabric; providing unified network channel and content security.

Software Associates helps healthcare customers design and implement such a unified network channel and enterprise content security solution today enabling customers to easily define policies such as “No Instant Messaging on our network” or “Prevent patient data leaving the company over any channel that is not an authorized SSH client/server”.

For more information contact us.

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Apps vs. the Web, enemy or friend?

Saw this item on Gigaom.

George Colony, the chairman and CEO of Forrester Research, re-ignited a minor firestorm recently, with a presentation at the LeWeb conference in which he argued that the web is dead, and being replaced by the app economy — with mobile and smartphone apps that leverage the cloud or other services rather than the open web.

I have written here and here about the close correlation between Web application security and Web performance.

I know that Mr. Colony has sparked some strong sentiment in the community, in particular from Dave Winer:

If I can’t link in and out of your world, it’s not even close to a replacement for the web. It would be as silly as saying that you don’t need oceans because you have a bathtub. How nice your bathtub is. Try building a continent around it.

Of course, that is neither true nor relevant.

Many apps are indeed well connected, and the apps that are not wired-in, don’t have to be wired; the app is simply doing something useful for the individual consumer (like iAnnotate displaying a PDF file of music on a iPad or Android tablet).

iAnnotate turns your iPad into a world-class productivity tool for reading, annotating, organizing, and sending PDF files. Join the 100,000s of users who turn to iAnnotate for their PDF annotating needs. We designed iAnnotate to suit your individual workflow.

I became even more cognizant that apps may overtake the open Web over the past 2 weeks when Google Apps was going through some rough spots and it was almost impossible to read email to  software.co.il or access or calendars…except from our Android tablets and Nexus S smartphones.   Chrome and Google Apps was almost useless but Android devices just chugged on.

There is a good reason why apps are overtaking the open browser-based web.

They are simply more accessible, easier to use and faster.

This is no surprise as I noted last year:

The current rich Web 2.0 application development and execution model is broken.

Consider that a Web 2.0 application has to serve browsers and smart phones. It’s based on a heterogeneous server stack with 5-7 layers (database, database connectors, middleware, scripting languages like PHP, Java and C#, application servers, web servers, caching servers and proxy servers.  On the client-side there is an additional  heterogeneous stack of HTML, XML, Javascript, CSS and Flash.

On the server-side, we have

  • 2-5 languages (PHP, SQL, tcsh, Java, C/C++, PL/SQL)
  • Lots of interface methods (hidden fields, query strings, JSON)
  • Server-side database management (MySQL, MS SQL Server, Oracle, PostgreSQL)

On the client side, we have

  • 2-5 languages ((Javascript, XML, HTML, CSS, Java, ActionScript)
  • Lots of interface methods (hidden fields, query strings, JSON)
  • Local data storage – often duplicating session and application data stored on the server data tier.

A minimum of 2 languages on the server side (PHP, SQL) and 3 on the client side (Javascript, HTML, CSS) turns developers into frequent searchers for answers on the Internet (many of which are incorrect)  driving up the frequency of software defects relative to a single language development platform where the development team has a better chance of attaining maturity and proficiency. More bugs means more security vulnerabilities.

More bugs in this complex, broken execution stack means more things will go wrong and as devices and apps are almost universally accessible now; it means that customers like you and me will not tolerate 2 weeks of downtime from a Web 2.0 service provider.  If we have the alternative to use an app on a tablet  device, we will take that alternative and not look back.

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The death of the anti-virus

Every so often my ISP calls us up and asks to speak with the IT manager or the person who is responsible for the network.

This time it was Netvision offering me a special deal on Symantec anti-virus and a $5/month service package for virus updates.

Well, I said “We don’t use Windows, and I have not installed nor used an anti-virus for over 9 years”. The sales person asked me what we use and I replied Ubuntu. Never heard of it, she said. So – I told her – “imagine a free operating system that installs in 15′ with thousands of world-class free software and no need to  run an anti-virus and it looks like a Mac”. She said – wow that sounds good.  Maybe I should check it out.

Who needs an anti-virus? If I have a solid operating system like Ubuntu 11.10, iptables, good control of the services on my notebook and practice safe email, why should I add additional layers of content security and feed the Symantec stock price?

Additional security controls do not necessarily reduce risk.

Installing more security products is never a free lunch and tends to increase the total system risk and cost of ownership, as a result of the interaction between the elements.

Many firms see the information security issue as mainly an exercise permissions and identity management (IDM). However, it is clear from conversations with two of our large telecom customers that (a) IDM is worthless against threats of trusted insiders with appropriate privileges and (b) Since the IDM systems requires so much customization (as much as 90% in a large enterprise network) it actually contributes additional vulnerabilities instead of lowering overall system risk.

The result of providing inappropriate countermeasures to threats, is that your cost of attacks and ownership go up, instead of your risk going down. This is as true for a personal workstation as it is for a large enterprise network.

The question from a security perspective of an individual user is pretty easy to answer. Install a decent personal firewall (not Windows and please stay away from Symantec) and be careful.

For a business, the question is harder to answer because it is a rare company that has such deep pockets they can afford to purchase and install every security product recommended by their integrator and implement and enforce all the best-practice controls recommended by their accountants.

An approach we like is taking standards-based risk assessment and implementing controls that are a good fit to the business.

Our 6 step business threat analysis methodology enables any business  to build a quantitative risk model and construct an economically-justified, cost-effective set of countermeasures that reduces risk in their and their customers’ business environment.

More importantly, a company can execute a “gentle” implementation plan of controls concomitant with its budget instead of an all-or-nothing compliance checklist implementation that may cost mega-bucks.

And in this economy – fewer and fewer businesses have the big bucks to spend on security and compliance.

Software Associates specializes in helping medical device vendors achieve HIPAA compliance and improve the data and software security of their products in hospital and mobile environments in the best and most cost-effective way for your business and pocketbook.

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Killed by code

I think it’s only a question of time before we have a drive by execution of a politician with an ICD (implanted cardiac device).

I’ve been talking to our medical device customers about mobile security of implanted devices for over a year now.

I  gave a talk about mobile medical device security at the Logtel Mobile security conference in Herzliya a year ago and discussed proof of concept attacks on implanted cardiac devices with mobile connectivity.

Mocana, is a company with a pretty impressive line of security products for embedded devices – working at the firmware layer it appears. Mocana secures the “Internet of Things” – the 20 billion non-PC devices that are increasingly connecting to networks across every sector of our economy including Smartphones, Datacom, Smartgrid, Federal, Consumer and Medical. These devices already outnumber workstations on the Internet by about five to one, representing a $900 billion market that’s growing twice as fast as the PC market.

The Mocana Deviceline blog reports that “Alarmed by new research showing the increasing vulnerability of wireless implanted medical devices, two members of Congress have asked for hearings on the security of these devices

Mobile and medical and regulatory is a pretty sexy area and I’m not surprised that politicians are picking up on the issues. After all, there was an episode of CSI New York last year that used the concept of an EMP to kill a person with an ICD, although I imagine that a radio exploit of  an ICD or embedded insulin pump might be hard to identify unless the device itself was logging external commands.

Congress was more concerned about the regulatory issues than the patient safety and security issues:

Representatives Anna Eshoo (D-CA) and Ed Markey (D-MA), both members of the House Energy and Commerce Committee sent a letter last August asking the GAO to Study Safety, Reliability of Wireless Healthcare Tech and report on the extent to which FCC is:

  • Identifying the challenges and risks posed by the proliferation of medical implants and other devices that make use of broadband and wireless technology.
  • Taking steps to improve the efficiency of the regulatory processes applicable to broadband and wireless enabled medical devices.
  • Ensuring wireless enabled medical devices will not cause harmful interference to other equipment.
  • Overseeing such devices to ensure they are safe, reliable, and secure.Coordinating its activities with the Food and Drug Administration.

At  Black Hat August 2011, researcher Jay Radcliffe, who is also a diabetic, reported how he used his own equipment to show how attackers could compromise instructions to wireless insulin pumps.

Radcliffe found that his monitor had no verification of the remote signal. Worse, the pump broadcasts its unique ID so he was able to send the device a command that put it into SUSPEND mode (a DoS attack). That meant Radcliffe could overwrite the device configurations to inject more insulin. With insulin, you cannot remove it from the body (unless he drinks a sugary food).

The FDA position that it is sufficient for them to warn medical device makers that they are responsible for updating equipment after it’s sold and the downplaying of  the threat by industry groups like The Advanced Medical Technology Association is not constructive.

Following the proof of concept attack on ICDs by Daniel Halperin from the University of Washington, Kevin Fu from U. Mass Amherst et al “Pacemakers and Implantable Cardiac Defibrillators:Software Radio Attacks and Zero-Power Defenses”  this is a strident wakeup call to medical device vendors  to  implement more robust protocols  and tighten up software security of their devices.

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Information Security Best Practices

Medical device security

What is more important – patient safety or the health of the enterprise hospital Windows network?  What is more important – writing secure code or installing an anti-virus?

Software Associates specializes in helping medical device vendors achieve HIPAA compliance and improve the data and software security of their products in hospital and mobile environments.

A threat analysis was performed on a medical device used in intensive care units.  The threat analysis used the PTA (Practical threat analysis) methodology.

Our analysis considered threats to three assets: medical device availability, the hospital enterprise network and patient confidentiality/HIPAA compliance. Following the threat analysis, a prioritized plan of security countermeasures was built and implemented including the issue of propagation of viruses and malware into the hospital network (See Section III below).

Installing anti-virus software on a medical device is less effective than implementing other security countermeasures that mitigate more severe threats – ePHI leakage, software defects and USB access.

A novel benefit of our approach is derived by providing the analytical results as a standard threat model database, which can be used by medical device vendors and customers to model changes in risk profile as technology and operating environment evolve. The threat modelling software can be downloaded here.

Continue reading

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Why Microsoft Windows is a bad idea for medical devices

I’m getting some push back on LinkedIn on my articles on banning Microsoft Windows from medical devices that are installed in hospitals – read more about why Windows is a bad idea for medical devices here and here.

Scott Caldwell tells us that the FDA doesn’t rule “out” or “in” any particular technology, including Windows Embedded.

Having said that, Microsoft has very clear language in their EULA regarding the use of Windows Embedded products:

“The Products are not fault-tolerant and are not designed, manufactured or intended for any use requiring fail-safe performance in which the failure of a Product could lead to death, serious personal injury, severe physical or environmental damage (“High Risk Activities”).”

Medical device vendors  that  use Windows operating systems for less critical devices, or for the user interface are actually increasing the threat surface for a hospital, since any Windows host can be a carrier of malware that can take down the entire hospital network, regardless of it’s primary mission function, be it user-friend UI at a nursing station or intensive care monitor at the bedside.

Medical device vendors that use Microsoft IT systems management “best-practices” often  take the approach of “bolting-on” third party solutions for anti-virus and software distribution instead of developing robust, secure software, “from the ground up” with a secure design, threat analysis, software security assessment and secure software implementation.

Installing third-party security solutions that need to be updated in the field, may be inapplicable to an embedded medical device as the MDA (Medical Device Amendments of 1976) clearly states:

These devices may enter the market only if the FDA reviews their design, labeling, and manufacturing specifications and determines that those specifications provide a reasonable assurance of safety and effectiveness. Manufacturers may not make changes to such devices that would affect safety or effectiveness unless they first seek and obtain permission from the FDA.

It’s common knowledge that medical device technicians use USB flash drives and notebook computers to update medical devices in the hospital. Given that USB devices and Windows computers are notoriously vulnerable to viruses and malware, there is a reasonable threat that a field update may infect the Windows-based medical device. If the medical device is isolated from the rest of hospital network, then the damage is  localized, but if the medical device is networked to an entire segment, then all other Windows based computers on that segment may be infected as well – propagating to the rest of the hospital in a cascade attack.

It’s better to get the software security right than to try and bolt in security after the implementation.Imagine that you had to buy the brakes for a new car and install them yourself after you got that bright new Lexus.

It is not unusual for medical device vendors to fall victim to the same Microsoft marketing messages used with enterprise IT customers – “lower development costs, and faster time to market” when in fact, Windows is so complex and vulnerable that the smallest issue may take a vendor months to solve. For example – try and get Windows XP to load the wireless driver without the shell.   Things that may take months to research and resolve in Windows are often easily solved in Linux with some expertise and a few days work. That’s why you have professional medical device  software security specialists like Software Associates.

With Windows, you get an application up and running quickly, but it is never as reliable and secure as you need.

With Linux, you need expertise to get up and running, and once it works, it will be as reliable and secure as you want.

Yves Rutschle says that outlawing Microsoft Windows from medical devices in hospitatls  sounds too vendor-dependant to be healthy (sic) (Seems to me that this would make the medical device industry LESS vendor-dependent, not more vendor-dependent, considering the number of embedded Linux options out there.)

Yves suggests that instead, the FDA should create a “proper medical device certification cycle. If you lack of inspiration, ask the FAA how they do it, and maybe make the manufacturers financially responsible for any software failure impact, including death of a patient“. (The FDA does not certify medical devices, they grant pre-market approval).

I like a free market approach but consider this:

(Held)The MDA’s pre-emption clause bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA. Pp. 8–17.

Maybe the FDA should learn from the FAA but in the meantime, it seems to me if the FDA pre-market validation process had an item requiring a suitable operating system EULA, that would pretty much solve the problem.

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The ethical aspects of data security

Ethical breaches or data breaches.

I was standing in line at Ben Gurion airport, waiting for my bag to be x-rayed. A conversation started with a woman standing next to me in line. The usual sort – “Where are you traveling and what kind of work do you do?”. I replied that I was traveling to Warsaw and that I specialize in data security and compliance – helping companies prevent trusted insider theft and abuse of sensitive data.

She said, “well sure, I understand exactly what you mean – you help enforce ethical behavior of people in the organization”.

I stopped for a moment and asked her, hold on – “what kind of business are you in”? She said – “well, I worked in the GSS for years training teams tasked with protecting high echelon politicians and diplomats. I understand totally the notion of enforcing ethical behavior”. And now? I asked. Now, she said, ” I do the same thing, but on my own”.

Let’s call my new friend “Sarah”.

Sarah’s ethical approach was for me, a breath of fresh air. Until that point, I had defined our data security practice as an exercise in data collection, risk analysis and implementation of the appropriate technical security countermeasures to reduce the risk of data breach and abuse. Employees, competitors and malicious attackers are all potential attackers.  The objective is to implement a cost-effective portfolio of data security countermeasures – policies and procedures, software security assessments, network surveillance, data loss prevention (DLP) and encryption at various levels in the network and applications.

I define security as protecting information assets.

Sarah defines security as protecting ethical behavior.

In my approach to data security, employee behavior is an independent variable, something that might be observed but certainly, not something that can be controlled. Since employees, contractors and business partners tend to have their own weaknesses and problems that are not reported on the balanced score card of the company, my strategy for data security posits that it is more effective to monitor data than to monitor employees and prevent unauthorized transfer or modification of data instead of trying to prevent irrational or criminal behavior of people who work in the extended enterprise.

In Sarah’s approach to data security, if you make a set of rules and train and enforce ethical behavior with good management, sensing and a dosage of fear in the workplace; you have cracked the data security problem.

So – who is right here?

Well – we’re both right, I suppose.

The answer is that without asset valuation and analysis of asset vulnerabilities, protecting a single asset class (human resources, data, systems or network) while ignoring others, may be a mistake.

Let’s examine two specific examples in order to test the truth of this statement.

Consider a call center with 500 customer service representatives. They use a centralized CRM application, they have telephones and email connectivity. Each customer service representative has a set of accounts that she handles. A key threat scenario is leaking customer account information to unauthorized people – private investigators, reporters, paparazzi etc… The key asset is customer data but the key vulnerability is the people that breach ethical behavior on the way to breaching customer data.

In the case of customer service representatives breaching customer privacy, Sarah’s strategy of protecting ethical behavior is the best security countermeasure.

Now, consider a medical device company with technology that performs imaging analysis and visualization. The company deploys MRI machines in rural areas and uses the Internet to provided remote expert diagnosis for doctors and patients who do not have access to big city hospitals. The key asset transmitted from the systems for remote diagnosis is PHI (protected health information), and the key vulnerabilities are in the network interfaces, the applications software and operating systems that the medical device company uses.

In  the case of remote data transfer and distributed/integrated systems, a combined strategy of software security, judicious network design and operating system selection (don’t use Microsoft Windows…) is the correct way to protect the data.

My conversation with Sarah at the airport gave me a lot of food for thought.

Data loss prevention (DLP technology) is great  and  ethical employee behavior is crucial but they need to work hand in glove.

Where there are people, there is a need to mandate, monitor and reinforce ethical behavior using  a clearly communicated corporate strategy with employees and contractors. In an environment where users require freedom and flexibility in using applications such as email and search, the ethical behavior for protecting company assets starts with company executives who show from personal example that IT infrastructure is to be used to further the company’s business and improving customer service and not for personal entertainment, gain or gratification.

It’s the simple things in life that count.

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Why outlawing Windows from embedded medical devices is a good idea

In a previous post The Microsoft Monoculture as a threat to national security, I suggested that the FDA might consider banning Windows as an operating system platform for medical devices and their accompanying information management systems.

One of my readers took umbrage at the notion of legislating one monoculture (Microsoft) with another (Linux) and how the Linux geeks are hooked on the CLI just like Windows users are hooked on a GUI.

The combination of large numbers of software vulnerabilities,  user lock in created by integrating applications with Windows,  complexity of Microsoft products and their code and Microsoft predatory trade practices are diametrically different than Linux and the FOSS movement.

One of the biggest threats to medical devices in hospitals is the widespread use of USB flash disk drives and Windows notebooks to update medical device software. With the infamous auto-run feature on Microsoft USB drives – flash memory is an easy attack vector for propagating malware via Windows based medical devices into a hospital network. This is one (and not the only) reason, why I am campaigning against use of Windows in medical devices.

This  has nothing to do with the CLI or GUI of the operating system and personal preferences for a user interface.

This has everything to do with manufacturing secure embedded medical devices that must survive in most demanding, heterogeneous and mission critical environment one can imagine – a modern hospital.

I never advocated mandating Linux by law for medical devices.

It might be possible to mandate a complex set of software security requirements instead of outlawing Windows in embedded medical devices as a more politically-correct but far more costly alternative for the the FDA and the US taxpayer.

Regardless of the politics involved (and they are huge…) – if the FDA were to remove Windows from an approved list of embedded medical device operating systems – the costs to the FDA would decrease since the FDA would need less Windows expertise for audits and the threat surface they would have to cover for critical events would be smaller.

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Medical device security in a hospital network

Medical devices are everywhere today.  In your doctors office measuring your blood pressure, at your cosmetician (for hip reduction…) and in the hospital for everything from patient monitoring to robot-assisted surgery.

The people that develop embedded medical devices based on Intel platforms know that Windows is vulnerable.

Lacking embedded Linux know-how, medical device developers often end up adopting Windows and Visual Studio as a default. Using Windows is a security-blanket for developers who grew up in the Microsoft Windows monoculture and are scared of the Linux command line.

But – make no mistake using Windows in networked embedded medical devices is a mistake.
This is big mistake #1.

The top 2 threats to a medical device are software defects and software updates.
Consider the implications of updating patient monitoring devices in a hospital with an infected USB stick or an infected Windows notebook.

In product development (and medical device are  no exception),  the support and version update process  is often something  left for the end of the project. At that point, when the product manager asks how are we going to update the software in the field – the hands raise in favor of  USB memory stick updates as an “interim” solution.

It is crucial to use threat analysis on systems of networked medical devices in order to arrive at the right, cost-effective countermeasures (apropos the management challenge of large number of VLANS…). Threat analysis must be an integral part of the SDLC (software development life cycle) – done early in the process and validated from time to time whenever there are significant design, configuration or environmental changes.

Threat analysis enables a medical device vendor and the hospital security team to have an objective discussion on balancing the need to protect the hospital network asset with protecting the availability of the medical device  itself and concomitantly – the safety of patients that are dependent on the device – patient monitoring is the first example that comes to mind.

Unfortunately many device vendors and their hospital customers use a system management model based on Microsoft Windows and business IT management practices. This is big mistake #2.

Medical device vendors need to assess their software security and not assume that an embedded medical device running Windows XP   is no different from any other Windows PC on the network running Office 2007.

To use an analogy from the world of real time embedded systems – consider avionics as key to safety of the pilot and success of the mission. Avionics are not managed like a network of Windows PCs and neither should medical devices on the hospital network.

A medical device in a hospital network – whether it monitors patients, assists in surgery or analyzes EEGs – is an embedded device in a extremely heterogeneous and hostile environment that should simply not be vulnerable to Microsoft Windows malware.

Embedded medical devices should be based in embedded Linux – and not a stock version of Red Hat – but rather built ground up from the latest Linux kernel, with the minimum set of services and software (Qtk etc…) needed to run the application.  The software update process should be part of the design – not something bolted on after the implementation.

Developing for embedded Linux is not copy and paste from Windows. It requires expertise to setup the basic infrastructure.  But – once that infrastructure is up, the medical device developer and it’s hospital customer can be confident that they are standing on a secure platform and not a house of glass built on a foundation of sand.

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