In last month’s Tech Talk column, Elliot Sloane presented an overview of Integrating the Healthcare Enterprise (IHE) interoperability. While the IHE initiative has been very successful in moving vendors toward better interoperability between medical devices and information systems, there is still significant work that needs to be done by vendors in terms of device interoperability, particularly in clinical areas that have generally not been covered by IHE, or have only recently been added to IHE. As clinical engineers (CEs) and biomedical equipment technicians (BMETs) get more and more exposure to IHE, they become better educated on the interoperability needs of the equipment they support on a day-to-day basis. However, many biomeds have had very little exposure to IHE other than in places like the previously mentioned column. And other hospital staff may have even less exposure to IHE. Nevertheless, interoperability is so vital to successful patient care these days that it cannot be ignored. This is where clinical engineering can provide a valuable service for the hospital, even with limited IHE exposure.

Outlining Data Flow

Before any new equipment is brought into the hospital, relevant parties should decide what data must be provided to that device and what data needs to be exported from that device to any existing devices or systems in the hospital. Given their routine exposure to medical devices, CEs and BMETs often have a good understanding of what data is shared among different existing devices, and also have an understanding of where data needs to be shared. By working closely with clinical staff, biomeds can outline all the data needs of a device in the early stages of the selection process to ensure that these requirements are clearly specified to a vendor as part of a request for proposal or quotation request. This determination can be made whether or not a CE has a good understanding of the IHE initiative or relevant medical data exchange standards.

Certainly it would help if the clinical engineering department could translate specific data requirements into IHE workflows that could be presented to the various vendors. However, even if this is not the case, simply being able to define clearly what data needs to flow where within an organization is critical to ensuring that devices are selected that can meet these workflow needs. Biomeds should not shy away from interoperability planning and discussions merely because they lack significant exposure to IHE or standards.

Generally, the tricky part to interoperability is not determining what standards are applicable, but merely determining what data is needed where. Departments often do not know what data they need or what data they need to send to what systems. Furthermore, this is often a moving target, with requirements changing as departments realize what may be available to them. The clinical engineering department should be able to guide clinical staff through a determination of what data must be sent to/from a new medical device and what data would be beneficial to send to/from the device. It is important that the data requirements be as specific as possible. For example, rather than requiring patient demographics, the department should make the demographics to be included specific, such as name, patient identification, date of birth, allergies, etc. At a high level, a biomed could ask the following, or similar, questions:

  • What patient data is necessary at the time of the study, and is this data available in one or more systems/devices?
  • What study data is necessary at the time of the study, and is this data available in one or more systems/devices?
  • What clinical decision-making data, such as safe dosage ranges and outcomes data, would be necessary at the time of the study, and is that data available in one or more systems/devices?
  • What study data needs to be exported in real time during a study to be monitored on another system/device?
  • What study data needs to be exported to other systems after the study is completed?
  • What data needs to remain secure and/or private during transactions to and from the device?

Over what time frame—once at the start or end of the procedure, hourly, real-time—does a device need to receive, collect, and/or send specific data elements?

Determining Data Requirements

Often a good way to determine answers to these questions is to have clinical staff map out how a patient moves through a department and how any necessary data moves through the department, whether electronically, on paper, or on film.

Obviously, having knowledge of IHE and relevant standards would help a biomed to better question a clinical area as to the type of data they require, but CEs and BMETs should have enough clinical knowledge to be able to work with clinical staff to help them determine their data needs. And in performing this function across different clinical areas, biomeds should become more and more familiar with data requirements and the types of questions to ask, at the same time becoming more familiar with IHE.

Even in cases where a hospital’s information technology (IT) department has an understanding of interoperability initiatives and standards, IT may lack the clinical knowledge to identify specific data needs. A CE or BMET can then act as a liaison between the clinical staff and IT to help pass along specific clinical requirements to IT, which, in turn, can apply these requirements within an IHE framework.

In general, the takeaway message is that just because a biomed does not fully understand the IHE initiative, biomeds can act as a valuable resource in the interoperability process by helping to derive clinical data requirements that an IT resource or vendor can then interpret into IHE workflows.

Ken Olbrish, MSBE, is an enterprise imaging system administrator in the Information Services Department for the Main Line Health System, Philadelphia. For more information, contact .