Is Your Medical Viewer Diagnostically Approved? You Might Be At Risk.

Posted by P. Varma on Mar 2, 2018 11:00:00 AM

Is your medical imaging viewer diagnositcally approved? If not, you might be at risk.jpegThere’s nothing wrong with using a solution that works for you. That can be a solution that costs thousands of dollars for an annual subscription or one that comes completely free. We support the medical imaging community to use whatever platform and integrations that bring the most value to their business. However, there is a concern. If you are using a viewer that does not have FDA, CE, or other certifications - you might want to think twice before making a diagnosis.

Why it matters

Similar to how a patient would be upset to hear that their physician does not have the appropriate degree to be treating them; they would probably not be too happy to hear that the technology used to make their diagnosis was subpar. Worst case scenario, you miss something when you are looking at the imaging and give the wrong prognosis. If the patient really has a tumor and you saw it as a cyst - that kind of variation can mean the difference between life and death. It can also lead to a malpractice lawsuit. Basically, every physician can minimize the risk of running into this situation by using an approved platform.

Aside from the bad business aspect, it’s also unethical, and in some regions illegal to diagnose a patient off a non-diagnostic viewer.

Why are you using your existing solution?

If you are using your viewer as a storage device, then perhaps all of this talk about diagnostic approval won't matter to you. However, if you are really using it just for storage, be aware that your local workstation was not built with the intention to house an excess amount of data. Consider the Cloud as a safer alternative. This solution is built in with redundancy. So, if one defense goes down, another props up in its place.

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Which leads to another question. Are you using a non-diagnostic platform because it's free? Again, if you find your solution to be working just fine, that's great. However, it is probably a safe assumption to make that if you have read up till now, you are probably looking for a better alternative. Most free DICOM viewers, if they are free, have limited functionality and are not FDA or CE approved. In fact, the only free viewer we recommend is Horos, a truly free, open source product. No advertising, no pop-ups, but full functionality. And, they are currently fundraising to pursue FDA approval. Yet, again, if you are looking for a diagnostically approved solution that won't break the bank, go with the Cloud. You will save more money with this solution than any other; and the benefits far extend a local PACS.

Take note...

1. Terminology matters.

Don’t be the victim of phrases like “Diagnostic Quality”. That statement does not mean that the platform is diagnostically approved.

2. Web based browsers are eligible for diagnostic approval.

Just because your platform is web based or Cloud based, it doesn’t mean that it is not safe. While there are web-based alternatives you should be weary of, we recommend working with a reputable vendor. They will provide you with a Cloud based solution that is in fact appropriate for diagnosis. However, be sure to ask them if your images are diagnostically approved on all devices. Not all web-based viewers are appropriate for tablets or smartphones.

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3. Before you buy, make sure you do your research.

There are certain questions you should always ask your vendor before bringing out your credit card or check books. The biggest favor you can do for yourself is to ensure that certain boxes are checked off. For instance, what (if any) are the accreditations associated with the platform? Is this solution user friendly? Are you on your own when it comes to support, or do you have a dedicated support desk through your vendor that you can call with questions? Is your data secure? If you are treating humans, is sharing secure? Do you have the ability to view images anywhere at any time?

Final Thought

Don’t fall prey to viewers that market themselves as “Diagnostic Quality” and use them for diagnostic purposes. It could result in disability, death, and even a malpractice lawsuit. If you are using a non-diagnostic viewer with your medical imaging to make a diagnosis - stop. You have many options available to you. One of which include the Cloud, a cheaper alternative that offers unlimited storage options as well as premium security for your data.

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Topics: medical image viewer, FDA, diagnostic imaging

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