Information Security

Defending the digital infrastructure


Nick Mankovich: Maintaining health care privacy and security

In the world of health care, the more we value privacy, the harder we work to protect it.

I confess I used to run away from all professional discussions about privacy. I found them murky and contentious: a bit like religion or politics but peopled with lawyers, legislators, and lobbyists! Still, from my comfort zone of managing security controls I wrestled with the notion of privacy, which seemed to be something inside of confidentiality that kept squeezing out through the cracks to be much, much more. Worlds collide when a researcher says, "Well, it's my data about these patients, so I can give you access."

My turning point was purchasing an out-of-print copy of Alan Westin's 1967 book Privacy and Freedom. This prescient, insightful work provided a context for these difficult conversations and prompted me to adopt the following definition: "Privacy is the right of the individual to control information about him or herself." When feeling devilish, I'll throw in "perceived right" just to dangle the red cape and begin a lively discussion among colleagues from different countries.

Beyond giving me a chance to reflect on one of the big questions behind security, that definition essentially provided the driving force for my security work. In my world of health care, the need for security and privacy arose more than 2,500 years ago in the Hippocratic dictum, "All that may come to my knowledge in the exercise of my profession …ought not to be spread abroad, I will keep secret and will never reveal." The more we value privacy, the more we search for the best ways to protect it. Many of us who have worked in health care recognize this relationship as we support people in their efforts to stay and get well, providing the best care with the safest equipment. The high principles of safe, effective, and secure health and wellness allow us to carry on our daily work with a genuine passion. We recognize on a personal level our deep dependence on our industry's products and services during the most vulnerable times in our lives and the lives of our loved ones.

Five years after jumping off the security cliff into the problematic world of privacy, I feel more comfortable tackling the difficult discussions around both of them. They are meaningful discussions but seldom are they easy. That's because they test the limits of what people will tolerate as they meet head-on the life-changing aspects of technology in the 21st century. Many of us are not ready to give up our location every minute or share our innermost thoughts with strangers, but some of us are. How can we help companies and health care organizations navigate this diverse new world? Our seemingly miraculous IT-based devices and services have made the delivery of care much more effective but, unfortunately, very complex. We must reduce the complexity to give people choices and, when we don't know their choices, act conservatively and both secure and keep confidential their personal information.

I have learned that there are many security risk management practices that are transferrable into the world of privacy. As has been noted in these pages over and over again, it's not just a matter of marking off a checklist a set of features, settings or practices. It's about balancing the risks of security or privacy breach consequences with the cost of maintaining security and privacy. The underlying theme is risk management -- really thinking about how risk accrues if we fail to comply with law, regulation, policy, contract, ethical behavior or the choices of the individual. Working under the risk management umbrella led Philips Healthcare and I to manage two global interrelated programs -- one for product and services security and the other for privacy compliance.

Less than five years ago, Brian Fitzgerald of the U.S. Food and Drug Administration called together a diverse mix of health care folks to talk about the harm that was being done from poor networking of medical devices in hospitals. His agency had reports of injury and death as a result of improperly connected networked devices. In that first brainstorming meeting of December 2005, there were biomedical engineers, IT professionals, regulatory specialists, medical device risk management specialists, security professionals, and medical device engineering staff. Brian urged us to organize and do something to help the world avoid this harm. To avoid international mismatches and "not invented here" issues in government regulatory authorities, he suggested this be pursued as a global standard. Five years later, we are very close to the final vote on the first international standard to address the Application of Risk Management to IT-networks Incorporating Medical Devices (IEC-80001-1).

This standard lifts security and privacy risk out of the afterthought category into the mainstream of health care delivery. It does this by building around the principle that decisions in any new device integration project in health care need to be built around some simple concepts. In the parlance of IEC-80001-1, medical IT-network risk management proceeds with a careful examination and understanding of three key properties: (1) safety, (2) effectiveness and (3) data and systems security. By considering all three, we can first "do no harm" while effectively delivering on the organization's health care mission. This is done with careful and explicit treatment of the appropriate level of confidentiality, integrity, and availability.

Of course, today's IT staff and biomedical engineers are skillful at keeping the highest levels of safety and effectiveness. However, with IEC-80001's explicit inclusion of data and systems security breach into its definition of harm, we have paved the way for an open and honest discussion of the C-I-A impacts of an interconnection project or a network change. It allows a consideration of the harm brought to individuals when confidentiality is threatened and, for the first time, consideration of the harm of privacy compromise is an essential part of the IT, biomedical engineer, caregiver, and compliance discussions.

This is an exciting time. I believe that this new risk-based framework for bringing together caregivers, biomedical/clinical engineers, security professionals, and privacy professionals will improve the quality of care. Although not without effort or difficult choices (and some free falling), we now have a framework to discuss and decide on the best way to provide the highest levels of safety, effectiveness, and security.


Nick Mankovich

Title: Senior director of product security and privacy

Company: Philips Healthcare

Credentials: Ph.D., Biological Science, Certified Information Privacy Professional


  • Created a framework for product security that continuously improves the provision of products and services in a secure manner for the global customer base of Philips Healthcare, a $11.1 billion multi-national medical device/system and health care IT organization
  • Created a framework for privacy compliance in all facets of the Philips Healthcare business
  • Participated in the creation of the first-ever international standard for The Application of Risk Management to IT-networks Incorporating Medical Devices, a sea-change in the management of risk associated with medical IT-networks in all types of health care enterprises.
  • Member of core group that created the Medical Device Security Manufacturer's Disclosure Statement (MDS2) within the Medical Device Security Workgroup of Healthcare Information and Management Systems (HIMSS).
  • Created a customer website with clear articulation of security roles and responsibilities in the provision and servicing of medical devices and systems
  • Member of the founding HITRUST Executive Committee


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