HealthManagement, Volume 7 - Issue 2, 2012 HIT

Data privacy should be seen in a wider perspective of risk management  and governance. Due to recent events (e.g. the financial  crisis), governance and risk management are hot topics for media  coverage, especially within the financial sector. However, these  topics are also high on the agenda in the boardrooms of private  companies in the corporate world, due to earlier scandals like Enron  and Worldcom. Risk management is still in its infancy in healthcare,  even though risks are probably highest, involving human life.  

Responsibilities Regarding Risk Management  

Regardless of the type of organisation, it is the responsibility of  management to manage all risks of the organisation. This is also  the case in healthcare and non-profit organisations. Besides, it  is not only the responsibility of management to manage risk; it  is also the responsibility of the board of directors to supervise  whether risks are adequately managed within the organisation.  

Worse: If risks are not adequately managed and events (accidents)  occur, the directors can be held (legally) liable for this. This is not  just theory, but happens in practice. Members of the board of directors  often do not realise they hold ultimate responsibility the  final responsible and might be held liable in case of serious events.  This is also apparent in healthcare, where directors are often appointed  in an informal way, and where risks relate to human life.  

Many risks, especially in healthcare, cannot be reduced to zero.  Even when precautions are taken events could still occur. Precautions  reduce the probability or the impact of a risk, however,  risks are often not completely eliminated. Therefore, it is important,  in case of such an event, to be able to prove that measures  were taken to manage the risk and that the management  has reflected and taken conscious decisions to manage the  risk. Then, if it happens, at least the management took all possible  measures and cannot be accused of negligent omission.  

Which Risks Should be Managed?  

All risks of the organisation should be managed. There is  a wide variety of risks, the most common categories are:  

  • Medical and patient safety risk;  
  • Operational risk;  
  • Legal & compliance risk;  
  • Financial risk; and  
  • IT risk.  

Risks relate to all activities of the organisation, both on the care  and on the administrative side. Within the above risk categories,  there are many distinct risks that should be managed. For all important  risks, control measures should be taken to prevent them  from occurring and very often, IT plays an important role in this.  

What Does it Mean to Manage Risks?  

Proper risk management implies that:  

  • All important risks within the organisation are known  and assessed; this is typically done in a risk assessment  exercise;  Based on the risk assessment, conscious decisions are  taken to address the risks (or not!); and  
  • Based on these decisions, appropriate actions are taken  and measures are implemented to address the risks.  

A risk assessment is typically performed with the aid of external  consultants, preferably with experience in healthcare. The  main reason for this is that many of the risks are generic and  also present in similar organisations. A good consultant has  sector-specific risk models to conduct the risk assessment.  

The risk assessment is typically performed in two phases:  

  • Identification of all risks: This is typically done in workshops  with management starting from the generic risk  model; and  Evaluation of all identified risks: There are several methodologies  to evaluate risk; in practice both the probability and  impact of the risk occurrence (the event) are evaluated.  

The risk assessment exercise will provide you with an inventory  of all risks and their evaluation. Of course, the highest  risks will be addressed first.  

In a next stage, decisions are taken on how to address the  risks, based on their importance and possible measures. Basically,  risks can be addressed in the following ways:  

  • Reduce the risk by implementing control measures;  
  • Delegate the risk. In practice this is most often done via  insurance;  
  • Avoid the risk, for example by ending the related activities;  and  
  • Accept the risk and take no action.  

Indeed, the decision might be not to take any action. This might be  because the risk is low and the cost is high. Most important is that  these are conscious decisions, by management or even the board.  

The decisions should also be documented, known and supported  by all relevant people. Because, if ‘an accident’ happens, we want  to avoid ‘finger-pointing’ and ‘I thought you were taking care of this’.  Based on the decisions made, an action plan is defined, which  takes into account the priorities defined in the risk assessment.  

What About IT Risks?  

IT often plays an important role in management of risks, especially  operational and financial risks. On the other hand, there  are also the specific IT risks. These are typically categorised  with the acronym CIA:  

  • Confidentiality of information;  
  • Integrity of information; and  
  • Availability of information and systems.  

Confidentiality of information is much related to data privacy.  A commonly used definition of the confidentiality principle is:  ‘Only authorised people should have access to (view) confidential  information’. Confidentiality risks are related to the  abuse of the information. Typical control measures are related  to the secure protection of confidential information.  

Integrity of information is related to the correctness of the information.  A common definition of the integrity principle is: ‘Only  authorised people should have access to change information.'  Integrity risks are related to unauthorised changes to information.  In healthcare these changes might ultimately lead to inappropriate  medical decisions and actions, such as wrong medication.  Therefore, integrity of information is probably even more  important than confidentiality of information (data privacy) from  a risk point of view. Fortunately, typical control measures are  similar and also related to the secure protection of information.  

A lot of information has been digitalised over recent years,  and a lot of activities have been automated. New technologies  have been adopted, such as the electronic patient file and electronic  prescriptions. As a consequence, dependency on IT systems  has increased tremendously in the last few years, hence  the importance of systems availability. Needless to say what  the impact of unavailability of critical systems might be, fortunately  also non-IT management easily relates to this, which  facilitates decisions on investments to increase systems availability.  Examples are systems redundancy, virtualisation of  CPU and storage, Disaster Recovery Plans (DRP), etc.  

Information Security: Burden or Need?  

In many organisations, recently the focus has been on systems availability  and infrastructure. Less effort has been made on confidentiality  and integrity of information. An important reason for this is that  information security is not a popular subject and often associated with  passwords. End-users do not always see the benefits of this, especially  not in highly operational environments, such as hospitals.  

Therefore, it is important to find the equilibrium between operational  efficiency and security. Identification via badges or biometrics  (eg. finger prints) are examples of efficient and secure solutions.  

Awareness creation on information security is not easy, the  message should be that not only would an unauthorised person  gain access to confidential information (infracting data privacy  laws) and be able to modify critical information, but most important,  that people would believe it was YOU! Indeed, all actions  performed on IT systems are logged nowadays. In case of malicious  events, these logs are investigated and the events will be  linked to you personally.  

And, as earlier discussed, questions will probably also be raised towards  management and the directors on whether all precautions  have been taken to prevent this from happening; and whether sufficient  efforts were made towards information security.  

An Action Plan Towards Information Security  

We have seen that information security is an important element  of risk management. Therefore, it should be no surprise that the  approach to address information security is similar to the approach  on risk management.  

In a first phase, a risk assessment is performed consisting of:  

  • Identification of critical information from a confidentiality  and integrity point of view, starting from an inventory of all  systems and information; and  
  • Evaluation of the identified critical information: The degree  of criticality is determined based on the potential impact of  confidentiality or integrity breach of the information.  

Please note that the aspect of availability can easily be included  in this exercise. It should also be noted that in similar organisations,  critical information is also similar.  

In a next phase, an inventory is made of the information security  measures already in place to protect the critical information. These  measures include security procedures, access controls, passwords,  security settings, access rights, etc.  

Based on the criticality and security measures in place, it is determined  whether additional measures should be taken. What  is sufficient? This is a difficult and subjective discussion. Most  organisations refer to information security standards; the most  common is the ISO27001 standard. However, this standard  consists of 130 security controls to be put in place to comply  with the standard. This is not feasible for most organisations.  

So even when using standards, subjective decisions need to be  taken on what is acceptable and not. These decisions should not  be taken by the IT manager alone; other members of the management  team and often even the Board should be involved.  

Conclusion  

Data privacy should be seen in a wider context of information security  and risk management. Perfect security protection does not exist;  risks can never be completely eliminated. Even in ‘Mission Impossible’,  security was insufficient to keep the hero out of the computer…  

The most important thing is that conscious decisions are  taken based on analysis and that these are formally documented  and appropriate actions are taken. The outcome is  that liabilities are limited and no one should say “Ich habe es  nicht gewüsst .”(“I didn’t know about it”).  

«« Telemonitoring Can Make Cardiac Implant Therapy More Efficient and Cost-Effective


Call for Proposals Challenge 5: ICT for Health »»