Healthcare stakeholders

The institute has set out quite clearly the data it wishes to see presented in a submission from a stakeholder. For each of the three main groups of stakeholders, patient/carer groups, healthcare professional groups, and manufacturers and sponsors, there is a separate set of guidelines. These may be accessed via the NICE website and should be essential reading for all those involved in the preparation of a submission. 

In this chapter, we briefly discuss the market framework that supports the pharmaceutical industry. We argue that what is needed is a reformulation of pharmaceutical stakeholder obligations through the creation of a new framework - a different mental model that commits all the components of the global healthcare system to addressing the health needs of the developing countries. 

The term stakeholders in patient data access is in common use. In the future of medicine, all stakeholder classifications and definitions will need to be tightened up for data security purposes. Clinical messaging systems will ship patient information only to the stakeholders authorized to have access to that information, the main users, the practitioners, patients, policy makers, and payers who are the target populations for a clinical messaging system, and definitely not the maintenance staff, venture capitalists in healthcare, and outside investors. More specifically, the system would be set up as follows. Patients communicate with practitioners about healthcare needs, follow-up of chronic conditions, learning the results of tests, and the like Practitioners... 

Security services will be provided for applications to apply appropriate business rules for access control of records based on the identity, roles, and purposes (i.e., business functions), in addition to distributed security services for authentication, authorization, confidentiality, integrity and nonrepudiation, to protect the best interests of stakeholders. Later in this book we will discuss the notion of a stakeholder in healthcare. It suffices here to say that these are the people legitimately involved in healthcare such as the patient, physician, and emergency medical staff. In some definitions stakeholders are the only people who can access the patient record. There are usually a special provisionings for the emergency care staff to access the patient data without an explicit informed consent in the event that the patient is unconscious. 

There are three key requirements for the security services of the new healthcare system in terms of these stakeholders (1) protection of privacy for individual stakeholders to manage their consent, under their direct control, for other stakeholders access to their personal information (2) security that includes identification, authentication, authorization, data confidentiality, data... 

So how does this dilemma translate into HIT and CRM Suppose au organisation knows that an HIT system has a particular defect which introduces a degree of clinical risk. Are the stakeholders involved not duty bound to fix the issue immediately whatever the risk If a patient was to die or experience serious harm as a direct or indirect consequence of the issue would the manufacturer and/or healthcare organisation be immediately negUgent To take this to its logical conclusion, any risk associated with an HIT solution is surely intolerable. 

Note that in discussing availability and performance one needs to make reference to the stakeholders responsible for hosting the system. In practice this could be the healthcare organisation, software manufacturer or a third party. The principles of fault tolerance and resilience remain the same irrespective of which party takes commercial responsibility. However the stakeholder responsible for implementing controls will vary as will the information available to safety case developers. In this... 

A key purpose of the safety case and the associated hazard log is to formally communicate those controls which other stakeholders are required to implement. In many cases, this translates into a natural boundary between the supplier of a HIT system and the healthcare organisation who implements it. Safety cases frequently demarcate the scope at this convenient level and also make it possible for the parties developing safety cases to mirror the commercial contract. 

In many projects the conttols of most significance are those which traverse organisational boundaries. In other words where one party (often the software manufacturer) establishes that to mitigate the risk to acceptable levels another party (often the healthcare organisation) is reqnired to put in place certain measures. These external controls provide an ideal starling point for downstream stakeholders to begin to build their assurance strategy on top of the safety work done by the manufacturer. 

Objectively documenting a CRM assessment for a significant fault is a powerful tool in gaining stakeholder buy-in and effecting its resolution. This is particularly the case when a healthcare organisations needs to escalate a fault to the manufacturer. 

When patients and families are included in gatherings of patient safety stakeholders, their primary contributions have been to share stories of preventable injury in healthcare and their impact on patients lives. We are gratified to have made this contribution. The voice of patients and families who have suffered preventable medical injury is a powerful motivational force for healthcare providers across the globe who wish, first, to do no harm. 

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