80 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE JULY/AUGUST 2004

Clinical Notes

security: a new clinical engineering paradigm

Security is the new mantra.Particularly since the tragic eventsof 9/11, the world has becomepreoccupied with security. The

United States creates a cabinet post and anew mega entity called the Departmentof Homeland Security. The resources ofa countless number of government, pub-lic, and private organizations are nowfocused on security issues. Security top-ics are addressed regularly on televisionand in nearly every conceivable type ofmagazine, newspaper, journal, and con-ference. Security-related businesses andconsultants seem to be proliferating andpermeating every aspect of our businessand personal lives.

The world’s preoccupation withsecurity seems justified when we arecontinually confronted with soberingreports as to our vulnerability to attack.There are reported threats involving theuse of weapons of mass destruction,attacks to or involving the use of ourtransportation systems (e.g., air, rail,ship, and truck), biocontamination ofour water supplies and mail, and cyberattacks to our information systems.

The healthcare system is not immuneto the variety of threats that exist.Clinical engineers are increasinglybeing called on to address the securityvulnerabilities of medical technologythat has become integral to the deliveryof care. The need to address these secu-rity issues requires that clinical engi-neers adopt what will be for most a newparadigm. That paradigm, as it turnsout, effectively addresses not onlythreats associated with malfeasant actsbut any threat or risk that would com-promise the efficacy or availability ofthe medical technology that clinicalengineers typically manage.

The New ParadigmRather than focusing on the manage-ment of discrete devices as has been

the practice of traditional clinicalengineering services, the new “secu-rity” paradigm requires adoption of asecurity process that includes thefollowing:1) identifying and rating the technolo-

gy systems in terms of criticality ofthe information these systems main-tain or transmit (i.e., informationacquired through diagnostic systemsor acted on by therapeutic systems)

2) determining vulnerabilities the infor-mation is subject to and the proba-bility of information compromise foreach identified vulnerability

3) identifying existing security mea-sures in place to protect (e.g.,reduce the vulnerability of) infor-mation and any additional measuresthat would be necessary to achievean acceptable level of risk

4) developing a mitigation plan toimplement additional security mea-sures and establishing plan priori-ties based on information criticalityand the probability of compromise

5) testing and monitoring the effec-tiveness of the security process andmodifying the process to improvethat effectiveness as necessary.

Note that the emphasis in the securityprocess is on information. Medicaldevices must acquire, process, and/oract on information. Information is the“blood” sustaining the “body” that isthe healthcare process. Medical tech-nology serves as the vessel for thatinformation.

Clinical engineers need to developan understanding of the securityprocess and how that process must beapplied to preserve the integrity, avail-ability, and confidentiality of informa-tion. Failure to safeguard informationleads to the malfunction of medicaltechnology and the breakdown of thatportion of the healthcare process thatmedical technology supports. The con-

sequences to the patient of this break-down can range from injury to inappro-priate or delayed treatment to the lossof privacy. Conversely, an effectivesecurity process that successfully safe-guards the integrity, availability, andconfidentiality of information caninsure that medical technology is avail-able and applied in a manner that sup-ports the timely and effective deliveryof quality healthcare.

Some of the more common threats tothe integrity, availability, and confiden-tiality of information maintained or trans-mitted by medical technology include:➤ data accessed or modified (i.e., tam-

pering) by unauthorized personnelor processes (locally or remotely),including computer viruses andworms

➤ device or component failure➤ device/system errors (e.g., “out of

calibration”) ➤ device/system user misuse/abuse➤ electromagnetic interference (EMI)

or other adverse environmentaleffects

➤ erroneous data input (by processesor personnel)

➤ interruption of required utilities(e.g., power outage), services, orsupplies

➤ physical assault (e.g., fire, flood,theft, vandalism, accident)

➤ procedural violations by device/sys-tem users.

Once identified, threats must be evalu-ated as to their criticality and probabili-ty. Based on that evaluation, the clinicalengineer needs to develop a plan wherepriority is given to mitigating the mostcritical and most probable threats.Examples of safeguards to consider inthe mitigation process include:➤ antivirus software with regular

updates

Stephen L. Grimes

(continued on page 82)

82 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE JULY/AUGUST 2004

Book Reviews (continued)

The end of each chapter includes a con-clusion and a list of references. Thebook also includes a very helpful list ofsymbols that are widely used in severalchapters. This list does not include sym-bols that have been defined and intro-duced only in a limited section of thetext. The authors state that the book isaimed at graduate students in the physi-cal sciences and engineering and even

to undergraduate students in medicalphysics and “physics-literate” physi-cians. However, undergraduate studentsor interested physicians might not beequipped with the appropriate back-ground to comprehend all the material.Readers who are generally interested inan introduction to medical ultrasonicsbut lack a background in physics willface many challenges comprehending

the material. This book can be an excel-lent textbook for a graduate course inmedical ultrasonics and a valuable deskreference for researchers in the field.

—George Demiris, Ph.D.Director of the Health Informatics

Graduate ProgramDepartment of Health

Management and InformaticsUniversity of Missouri-Columbia

Clincal Notes (continued from page 80)

➤ device operating environment withappropriate physical safeguards(e.g., maintaining environmentalconditions and incorporating appro-priate protection against potentialphysical damage or loss)

➤ inventory of replacement compo-nents (to effect repairs) and devices(to provide backup systems)

➤ operating areas for device/systemthat are only accessible to and/orviewable by authorized personneland patients

➤ physical safeguards and alarmsintegrated with the device/system

➤ policy/procedure restricting or con-trolling use of EMI-generatingdevices in areas where this deviceis operated

➤ processes to insure timely updating,upgrading, or replacement of bio-medical devices/systems, whichincludes consideration of securityissues

➤ a program that insures adequatescheduled maintenance and calibra-tion of the device/system

➤ a program that insures security

updates for device operating systemare current

➤ routine data backups (with backupsstored in secure and accessiblelocations)

➤ secure data so as to be accessible toonly authorized personnel (e.g.,encryption, secure private net-works, virtual private networks,firewalls, lock and key, password,biometrics)

➤ secure operating controls so as tobe accessible to only authorizedpersonnel (e.g., lock/key, pass-words, biometrics)

➤ user education on measures neces-sary to prevent, detect, and addressdata (integrity, availability, confi-dentiality) problems associatedwith device/system

After applying appropriate safeguards,clinical engineering needs to test andmonitor the security process, modifying itas necessary to improve its effectiveness.

ConclusionSecurity has become a universal con-cern. It is time for clinical engineering

to get up to speed and recognize thebenefit an effective security process canbring to medical technology manage-ment. The security paradigm appropri-ately focuses on insuring the integrity,availability, and confidentiality ofinformation maintained and transmittedby medical devices rather than on themanagement of discrete devices. It isworthwhile noting that this process willsoon be required for US healthcareproviders. The U.S. Department ofHealth and Human Services has estab-lished a Security Rule [1] (part of theHealth Insurance Portability andAccountability Act’s AdministrativeProvisions), which will require theadoption of such a security process by21 April 2005.

References[1] U.S. Department of Health and Human Services,

“Security standards; Final rule,” Federal Register,

vol. 68, no. 34, 45 CFR Pts. 160, 162, and 164, Feb.

20, 2003. [Online]. Available: http://www.cms.

hhs.gov/hipaa/hipaa2/ regulations/security/03-

3877.pdf