GAO invites FDA to improve Information Security for medical devices

Pierluigi Paganini October 05, 2012

In the last decade the number of cyber incidents related to technologies that surround us is growth exponentially, the principal concerns are related to all those objects with an “intelligent component” that we daily use and that we expose on internet for different purposes.

This category includes also the Medical devices, elements with increasing complexity that are subject to possible hacking attacks.

Recently the US Government Accountability Office (GAO) has produced a new report highlighting the necessity to secure medical devices such as implantable cardioverter defibrillators or insulin pumps. The recommendation is directed to Food and Drug Administration (FDA) invited to approach the problem seriously considering incidents intentional caused to some devices.

FDA is the federal agency primarily responsible for evaluating the safety and effectiveness of medical devices through its premarket and postmarket efforts. FDA’s regulation of medical devices is intended to provide the public with reasonable assurance that medical devices are safe and effective and do not pose a threat to the public’s health.

Since now one of the main problems is that the experts despite are aware of cyber threats believe that efforts to mitigate related risks may adversely affect the performance of the devices.

“FDA considered information security risks from unintentional threats, but not risks from intentional threats, during its 2001 and 2006 premarket review of two medical devices that have known vulnerabilities. Specifically, FDA considered risks from unintentional threats for four of the eight information security control areas GAO selected for its evaluation/software testing:

  • verification, and validation;
  • risk assessments;
  • access control;
  • contingency planning.

“Information security refers to protecting information and information systems from unauthorized access, use, disclosure, disruption, modification, or destruction in order to preserve their confidentiality, integrity, and availability. These features improve physicians’ ability to treat patients. For example, a physician can now wirelessly access a patient’s defibrillator and make adjustments to the device as necessary.”

This document prepared by GAO identifies the threats that could eploit principal vulnerabilities in medical devices, and resulting information security risks.It’s requested to FDA to condider information security risks analyis in premarket approval (PMA) review process and also the review of all the devices actually on the market. The proposal represents a revolution in the mediacal scenarios with great impact on medical devices manufactures that are obliged to consider information security aspects of their systems and in the design phase have to reach the proper compromise between security and performances.

A famous hack has been demonstrated by the researcher of McAfee security firm, Barnaby Jack, that last year succeeded to alter the administration of the quantity of insulin that a pump delivers.

Majority of such devices use a radio transmission to let the medical staff to maintain it.

The attack exploited a vulnerability in the insulin pump’s radio control and its vibrating alert safety feature, similar incidents could have lethal consequences for patients.

The “hacks” works with different models of insulin pumps produced by Medtronic firm. The FDA hasn’t, until now, focused into intentional attacks and all those aspects related the prevention and response to these type of events but the menace is concrete and the risks have to be managed properly.

Despite the high level of alert haven’t been observed similar intentional attacks, but the GAO has enumerated the following Key Vulnerabilities in Active Implantable Medical Devices:

  • Limited battery capacity
  • Remote access
  • Continuous use of wireless communication
  • Susceptibility to electromagnetic (e.g., cellular) or other types of unintentional interference.
  • Limited or nonexistent authentication process (such as requiring a password) and authorization procedures
  • Disabling of warning mechanisms
  • Design based on older technologies
  • Inability to update or install security patches

The GAO document proposes in the document a series of recommendations to the Secretary of Health and Human Services that have to direct the Commissioner of FDA to develop and implement a plan to enhance surveillance on the security of medical devices.The minimal set of indications that the plan must include are:

  1. increase its focus on manufacturers’ identification of potential unintentional and intentional threats, vulnerabilities, the resulting information security risks, and strategies to mitigate these risks during its PMA review process;
  2. utilize available resources, including those from other entities, such as other federal agencies;
  3. leverage its postmarket efforts to identify and investigate information security problems; and
  4. establish specific milestones for completing this review and implementing these changes.
Which are the main intentional threat addressed by the document?
The document enumerates the following Intentional threat as principal causes
  • Unauthorized access – Unauthorized access could, for example, involve a malicious actor intercepting and altering signals sent wirelessly to the medical device
  • Malware – Malware is a malicious software program designed to carry out annoying or harmful actions. It often masquerades as or is embedded in useful programs so that users are induced to activate it.
  • Denial-of-service attack – A denial-of-service attack could be launched using computer worms or viruses that overwhelm a device by excessive communication attempts, making the device unusable by either slowing or blocking functionality or draining the device’s battery.
The following table proposes the Key Information Security Risks to Active Implantable Medical Devices

Is FDA unique responsible for security of medical devices?

No, there are several agencies responsible for security of the citizens, consider that an attacks against medical devices on large scale could harm national security, due this reason also DHS (Department of Homeland Security) and NIST (National Institute of Standards and Technology) have responsibilities related to mitigating information security risks affecting medical devices.

DHS’s responsibilities include collaborating with public and private entities to analyze and reduce information security threats and vulnerabilities coordinating DHS preparedness activities across critical-infrastructure sectors and the response efforts to information security incidents. The DHS is also responsible of reporting and alerting system of information security risks which include medical devices.

NIST is responsible for developing standards and guidelines to assist federal agencies in providing adequate information security for federal information and information systems.

DHS and NIST also maintain a National Vulnerability Database that allows users to search for information security vulnerabilities pertaining to specific products or technologies.

Since now the possibility of an attacks against medical devices has been ignored due the cruelty of the acts, but the eventuality must be prevented and related risks managed. Medical devices are becoming even more sophisticated, their capabilities to dialogue with external world for maintenance and alerting purposes is increased in impressive way such as the related vulnerabilities.

Let’s consider a MUST Information Security for medical devices.

Pierluigi Paganini

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