Tuesday, December 31, 2019

Top ten healthcare imaging informatics trends for 2020.

Several new trends have emerged over the past five years in the imaging and informatics field. Using the terminology from the Garter hype cycle[1], some of them have not made it beyond the innovation trigger (yet), some ended up at the peak of inflated expectations, others ended up in the trough of disillusionment, and some have emerged to become somewhat mature technologies. I used the hype cycle categorization to show where the top ten trends are right now and where I believe they might end up a year from now.

1.       Augmented reality (AR) – Augmented reality superimposes a computer-generated picture on a user’s view, which is typically on a patient. It has great potential, imagine medical students working on a virtual patient or using a virtual scalpel performing a virtual surgery instead of practicing on a human cadaver. Dissections can be done virtually, and one could even simulate errors similar to what happens with a flight simulator.

There are several start-ups that are working on this technology, but much improvement is still needed. It might take another iteration of a Google glass-like set of goggles to replace the big somewhat cumbersome glass sets I have seen so far. It will also be challenging to replace manual controls with 100 percent voice controls and/or a combination of voice and other bodily controls. This technology is still in its infancy, there are a couple of trial sites, mostly for surgery and we don’t know yet all of the pitfalls, and where it will be used, so this technology is definitely at the beginning of the hype curve.

2.       Artificial Intelligence (AI) – If you attended the recent RSNA tradeshow or are following the literature, you would see that AI is very much in the hype phase right now. I counted more than 100 dedicated AI companies, most of them have not gotten FDA clearance yet for their new algorithms, and the FDA is struggling to deal with these submissions as they don’t know how to deal with an application that is “self-learning” and has a potentially unpredictable future behavior.

There are ethical concerns as well, especially as these algorithms need a lot of data that is currently stored in the archives of many hospitals, and/or in the cloud of the big three cloud providers, which are supposedly being mined in a way that protects patient privacy, but in many cases without their consent. There are also concerns that some of the algorithms were tested on a limited, biased subset of patients and not including all of the various races and cultures with different gene-pools.

Given the momentum, this technology will continue on its hype curve as there will be several new applications being cleared by the FDA. It will take another three years before their first round of financing will run out and they will have to show a realistic ROI and potential to their initial investors. I expect that it will take another few years before it reaches its peak and users will see what it can and can’t do, before it will start to drop down into the valley of disillusionment and eventually mature.

3.       Blockchain (BC) – this technology still gets a lot of attention, but it is closer to its peak as it has become clear what you can do and what you can’t do with it. Blockchain provides a distributed ledger that is public, which makes its application in healthcare limited as most healthcare applications are looking to preserve privacy. The fact that it is immutable, however, provides opportunities with registries as you want those to be widely available and accessible. Occasionally you might hear about a physician practicing without proper licensing in a certain state, which would become a much less likely event if we had a publicly available registry in place.

Another application might be for large public data sets with anonymized patient information that can be used to test new algorithms for AI or healthcare practitioner training. People have become aware that blockchain has limited applications in healthcare and we are waiting for some of those to materialize so we can learn its pro’s and con’s before it matures.

4.       3-D printing – 3D printing is not new; it has been used for more than 25 years to build prototypes and rare parts. Its prerequisite is the presence of a computer-generated model that can be interpreted by the printer and then printed using the so-called additive manufacturing technique instead of the conventional machining, casting and forging process.

What is new is that these printers have become less expensive, 3-D modeling more sophisticated, and the recent standardization for a PACS workstation interface has given this application a boost. Its application is somewhat limited as it is currently used mostly for surgery planning and simulation. A 3D print can provide a visual model especially for complex procedures. There is still a great opportunity for surgical implants and prosthetics assuming that one can print using the right materials. What better use of the technology than replacement of an artificial limb, for example, that matches exactly the other body part in the case of a paired body part or one that fits exactly. Storing and labeling these 3-D models is still somewhat of a challenge especially if one creates many of them. This technology still has to go up toward its peak before it will fall back and become a mature technology.

5.       FHIR – This new interface standard has skyrocketed in its hype. It is widely touted as the solution to all of the current interoperability problems and has a large support from ONC (Office of National Coordinator) in the US. There are a few, limited applications being introduced on a very big scale, for example, the Apple iPhone has a plug-in allowing you to access your medical record in participating hospitals. I have seen more deployments internationally than domestically, for example, some in western Europe and one in Saudi Arabia where patients can access nationwide scheduling using their phone apps. There are a couple of challenges which will cause it to reach its peak of inflated expectations over the next one or two years.

The biggest issue is the speed of its introduction and corresponding lack of maturity. The first formal, normalized release (R4) was not approved until early 2019. The term “normalized” is deceiving as FHIR is basically a compilation of many individual mini specifications for the various resources of which in R4 there are only 11 in a final, normalized state out of the close to 150 resources. One could therefore argue that less then 10 percent of the spec is stable and ready for implementation as more than 90 percent can and most likely will have substantial changes to its interface.

Also, I believe that the current lack of interoperability in healthcare is not so much the lack of a well-defined interface, despite the issues with HL7 version 2 and the overkill and verbosity of CDA documents, but more due to the siloed architectures of our current EMR’s and other healthcare applications, and resistance by vendors and institutions to share information. It might require the pending “anti-blocking” rule by ONC to get some real teeth, success stories to become more widely known, and the standard to get more mature before it reaches its peak. I am worried about the speed and momentum because the faster you go, the more damaging it will be if you crash. As of now, FHIR is still going full speed ahead and it might take another two or three years before we will see it go past its peak.

6.       Cloud – The cloud right now is beyond its hype and traveling down its negative slope. Using the cloud as a back-up for data recovery has been mature for many years, but the advantages and disadvantages of outsourcing your IT solutions to a cloud platform has become clearer. From a security perspective, most healthcare institutions spend between three percent and six percent of their IT budgets on cyber security and they are becoming aware that it is hard to compete with the thousands of security experts that are employed by the big cloud providers. It also has become clear that you still need to manage your cloud applications well, especially the configuration settings, which became clear after the 2019 Capitol One breach, which is touted as one of the largest breaches ever. There is a lack of trust by the general public on how their data in the cloud is being used by the big cloud providers and whether it is sufficiently anonymized.

The cloud is not always a good solution as there could be a shift from the cloud to edge computing when processing real-time data. A typical response time from the cloud would be about one second which is fine when accessing and retrieving information for human interpretation but when making a split-second decision such as used for remote surgery, the cloud is too slow. The good news is that we typically don’t need to make these fast decisions, unlike self-driving cars that need to avoid potential obstructions. So, the cloud is definitely past its initial hype and next year we’ll discover more of its inflated expectations before we’ll see it mature in a few years.

7.       IOMT – The number of IOMT (Internet Of Medical Things) devices will continue to explode. The problem is that people are becoming highly dependent on these devices as illustrated by the recent data outage of DexCom, a company which allows caregivers to monitor the blood-sugar levels of their kids, parents and others. When this communication suddenly became disrupted, there was a semi-panic among caregivers.

This device is not the only IOMT device that is being introduced, there are intelligent extensions to a person’s handheld device to measure vital signs allowing for a telemedicine consult and wearables that are able to record and communicate with pacemakers, intelligent drug dispensers, a scale and other devices. Challenges with these devices are the unrealistic reliance on these technologies and corresponding immaturity, unreliability and lack of redundancy.

These IOMT devices interface easily with your mobile devices using blue tooth for example, but what about the next step, i.e. how does it get into an EMR? There is a mechanism in any EMR to upload the nurse observations and vitals that are measured by the same nurse, but how about uploading that information from my smart watch when I come into the doctor’s office?

Last but not least, there is a concern about cyber security provisions in this technology as potential weaknesses in pacemakers and IV pumps have been published. All of that makes IOMT still immature and it will take a few more years before it will start to slope up again and get to a plateau of productivity.

8.       VNA – Vendor Neutral Archives (VNA’s) used to be the biggest hype in medical imaging two or three years back. Initially it was positioned as the best solution to avoid costly and lengthy data migrations from hospitals that were switching PACS vendors. Each major PACS vendor was scrambling to catch up and replacing their PACS Archive labels with a VNA label, which created confusion in the marketplace about the functionality of a “true” VNA. Subsequently, the VNA became the source for image display for non-radiology physicians requiring web interfaces and connections with a Health Information Exchange using XDS protocols.

As of now, VNA is being repositioned as an enterprise archive with its own set of problems. There is a lack of synchronization of the data between the various PACS systems and VNA, for example, if there is a change in the patient demographics, images have to be deleted, or other adjustments made. Standards exist to address this issue as defined by IHE but there is little uptake on the PACS side for those.

The biggest stumbling block is the lack of a uniform workflow by non-radiology or cardiology specialties and inconsistent access for patient orders and/or encounter information. Also, as institutions are starting to rely on a single VNA to manage images from 100+ institutions, there are some serious concerns and issues around redundancy and scalability.

The VNA is definitely not mature yet, but its pitfalls are identified, it is slowly going up the slope of enlightenment, which will continue for the next two or three years. The concern is also that because most of the independent VNA vendors have been acquired by PACS vendors, their rate of innovation will be slowed down because of the transition and lack of focus.

9.       DR – Digital Radiography (DR) has been replacing Computerized Radiography (CR) for the past several years by being able to capture digital X-ray exposure and convert it directly into an electronic signal producing a picture withing a few seconds, instead of having to scan a CR plate in a reader. However, CR technology is still great for developing countries, whereby they are still converting from film to digital. [MO1] The DR plate technology has been greatly improved, it has come down in price but is still not cheap, plates used to be more than $50k and are now getting closer to $20k. They are now wireless, so you don’t need a cable to connect a plate that is being used for portable X-rays, which can be a safety hazard. As a matter of fact, I heard firsthand from a radiology administrator who had a technologist who tripped over the cable and he had to deal with a worker’s compensation case.

The battery life of the removable plates is getting better, with some lasting up to half a day or more. In addition, the way they are sealed has also improved providing better protection against leakage of bodily fluids. However, most of them are still based on glass silicon so they are heavy and subject to damage if dropped. All of these factors, price, battery life, leakage protection and weight can still be improved, which is why the technology has not reached its plateau of productivity and is still ascending on the slope of technology enlightenment. This will continue for the next few years.

10.   POC Ultrasound – Point of Care (POC) ultrasound has a big potential. It is inexpensive (~ $2k to $6k), portable, and adds value when used correctly. It could potentially become the equivalent of a stethoscope for the physicians. In addition, it can become a tool for non-physicians such as midwives or Physician Assistants.

Because of its low price point, there is a huge market opportunity in developing countries where there are no diagnostic tools at all available in the majority of cases. The factors that will cause it eventually to get over the hill of inflated expectations over the next one to two years are immature hardware and software product features, for example, some of the probes are known to get really warm, and there is still a lack of clinical measurements in the software such as needed for cardiac echo and OB/GYN, and there is no universal architecture yet as some of these devices can use a standard iPhone or Android phone/tablet and some require a company provided proprietary handheld device. Some of the POC devices require a cloud connection which is a problem when working in an area without connectivity and the business models vary between monthly fees and one-time purchase.

Last but not least, acquired images need to be archived, and there is an issue with matching the images with the correct metadata containing the patient information and any other encounter based important information.

In conclusion, the Gartner hype cycle has been criticized for a lack of evidence that every technology actually goes through this cycle, however, in my opinion, it seems to apply to most of the new technologies I have seen developing over the past several decades. Also, note that the ranking of these technologies in this article is my own personal opinion, and I might be wrong, and I promise to produce an update a year from now and admit any assumptions that appeared to have been incorrect. The main purpose of this ranking is to use this as input when making a decision to implement these technologies. It is fine to take a bet if you are a risky person and like to be on the “bleeding edge,” but if not, you might want to think twice about using a technology that is labeled immature or super-hyped. And of course, you can disagree with my ranking; I always encourage feedback and discussion.