In Part 1 of this blog series, I set the stage to understand who owns the machine data generated by medical devices such as CT, MRI, and so on. We also discussed how the restrictions on device data evolved over time and the implications on healthcare providers’ maintenance programs.
In Part 2, I’d like to discuss the approach we could take to resolve the debate. And, also present the legal framework that is in the works in the healthcare industry that may help us navigate this complex debate. Let’s first start by understanding the machine data environment from both manufacturers as well as Provider viewpoints.
How do manufacturers look at the accessibility of machine data?
Typically, manufacturers set a tiered structure to allow different levels of access to the buyer (hospitals, imaging outpatient clinics). Access to view the machine data is gated by a software key or code. The initial level of the tier is an inexpensive key or code that allows the hospital’s maintenance department to access just a few parameters to calibrate a device, for instance. If a higher level of access to information is required, for instance, error codes and recommendation articles to understand machine breakdown, a more expensive key or code is needed to be bought by the hospital. Through this tiered access to data, healthcare provider’s biomedical and clinical engineering teams are locked into manufacturers’ pricing structures by controlling the log data access from the machines.
Healthcare providers look for a way out of the data access deadlock
With multi-tiered services contact in place, over time, manufacturers' service contracts have become increasingly expensive, pushing healthcare providers to turn towards one of three routes: 1) hire independent service organizations (ISOs) to maintain and repair their equipment or, 2) build in-house clinical engineering program to handle maintenance activities themselves, or 3) have a hybrid approach combining best offers from all – manufacturers, ISOs, and in-house staff.
Regardless of any approaches outlined above, innovative healthcare providers have started asking the right questions from manufacturers so that they can access machine data from the machines to allow their ISOs or in-house staff to start mining this data to increase operational effectiveness. Good news is that such negotiations are yielding results. In such instances, manufacturers have divided data into two types, machine data, defined above, and remedial data, which is typically available in the form of knowledge bases provided only by the manufacturer; for example, prescriptive recommendations on how and when to replace the tube under specific error conditions. Such information access is chargeable by the manufacturer.
The division bell has rung
The current debate delineates the delicate line of manufacturers retaining ownership to their proprietary data while on the other hand healthcare providers trying to avoid every repair activity being an R & D project because of lack of access to the underlying machine diagnostic data.
Clearly, remedial data and knowledge bases are the property of the device manufacturer. However, the debate should be put to rest on the accessibility of machine data. Healthcare providers are right in saying that the machine data was logged after they had purchased the device, produced on their premises under their management. Hence machine “log” data belongs to the owners of these machines. Besides, healthcare providers save time, money, and resources if they have diagnostic information to shift unplanned downtimes to planned maintenance windows. In the end, making machine data accessible to all service technicians, whether employed by the manufacturer, ISO, or in-house staff, makes the whole industry more efficient in creating a universal knowledge base on how to become more proactive, predictive and prescriptive leveraging latest analytics and AI/ML tools.
In the final concluding and part 3 of this series, I will tackle the “right to repair” regulation, learnings from other industries such as data center equipment market, and it’s implication on access to machine data for Providers, along with a 5-point action plan for Providers to consider in establishing data ownership while they make their investments, esp. in complex medical devices.
Keep your feedback flowing…
I received enthusiastic responses on part 1 presenting a wide range of views on this debate. Would love to hear what you have to say on this edition of the post, do share your views - firstname.lastname@example.org.
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