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IBM Works To Avoid FDA Oversight For Its Watson Software

Posted on October 25, 2017 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

I live in DC, where the fog of politics permeates the air. Maybe that’s given me more of a taste for political inside baseball than most. But lest the following story seems to fall into that category, put that aside – it actually involves some moves that could affect all of us.

According to Stat News, IBM has been lobbying hard to have its “cognitive computing” (read: AI) superbrain Watson exempt from FDA oversight. Earlier this year, eight of its employees were registered to lobby Congress on this subject, the site reports.

Through its Watson Health subsidiary, IBM has joined the crowded clinical decision support arena, a software category which could face FDA regulation soon.

Historically, the agency has dragged its heels on issuing CDS review guidelines. In fact, as of late last year, one-third of CDS developers were abandoning product development due to their uncertainty about the outcome of the FDA’s deliberations, according to a survey by the Clinical Decision Support Alliance.

Now, the agency is poised to issue new guidelines clarifying which software types will be reviewed and which will be exempt under the provisions of the 21st Century Cures Act. Naturally, IBM wants Watson to fall into the latter category.

According to Stat News, IBM spent $26.4 million lobbying Congress between 2013 and June 2017. While IBM didn’t disclose how much of that spent on the CDS regulation issue, it did tell the site that it was “one of many organizations, including patient and physician groups, that supported a common sense regulatory distinction between low-risk software and inherently higher-risk technologies.”

IBM also backed a bill known as the Software Act, which was opposed by the FDA office in charge of device regulation but backed enthusiastically by many software makers. The bill, which was first introduced in 2013, specified that health software would be exempted from FDA regulation unless it provided patient-specific recommendations and posed a significant risk to patient safety. It didn’t pass.

Now, executives with the computing giant will soon learn what fruit their lobbying efforts bore. The FDA said it intends to issue guidance documents explaining how it will implement the exemptions in the 21st Century Cures Act during the first quarter of next year.

No matter what direction it takes, the new FDA guidance is likely to be controversial, as key regulatory language in the 21st Century Cures Act remains open to interpretation. The law includes exemptions for advisory systems, but only if it’s they allow “health care professional to independently review the basis for such recommendations.”  Lawyers representing software makers told Stat News that no one’s sure what the phrase “independently review the basis” means, and that’s a big deal.

Regardless, it’s the FDA’s job to figure out what key provisions in the new law mean. In the meantime, waiting will be a bit stressful even for giants like IBM. Big Blue has made a huge bet on Watson Health, and if the FDA doesn’t rule in is favor, it might need a new strategy.

Virtual Reality Offers New Options For Healthcare Data Analysis

Posted on September 21, 2017 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

I don’t know about you, but I’ve always been interested in virtual reality. In fact, given my long-time gaming habit, I’ve been waiting with bated breath for the time when VR-enabled games become part of the consumer mainstream.

Until I read the following article, however, I hadn’t given much thought to how VR technology could be used outside of the consumer sphere. In the article, the author makes a compelling case that VR tools may be the next frontier in big data analytics.

The author’s arguments include the following:

  • VR use allows big data users to analyze data dynamically, as it allows users to “reach out and touch” the data they are studying.
  • Using an approach known as immersive data visualization, coupled with haptic or kinesthetic interfaces, users can understand data intuitively and discover patterns.
  • VR allows users to view and manipulate huge amounts of data simply by looking at them. “VR enables you to capably stack relevant data, pare it and create visual cues so that you can cross-refer instantly,” the author writes.
  • With VR tools, users can interact naturally with data. Rather than glancing at reports, or reviewing spreadsheets, they can “manipulate data streams, push windows around, press buttons and actually walk around data worlds,” the article says.
  • VR makes multi-dimensional data analysis simpler. By using their hands and hearing, you just can pin down the subject, location and significance of specific data sources.

Though these concepts have been percolating for quite a while, I haven’t found any robust use cases for VR-based big data analytics either in or outside of healthcare. (They may well exist, and if you know of one above to hear about it.)

Still, a wide range of healthcare-related VR applications are emerging, including both inpatient care and medical education. I don’t think it will be long now before smart health IT leaders like yourselves begin to apply this approach to healthcare data visualization.

Ultimately, it seems likely that some of the healthcare data technologies are in play will converge with VR applications. By combining immersive or partially-immersive VR technologies with AI and big data analytics tools, healthcare organizations will be able to transform their data-guided outcomes efforts far more easily. And future use cases abound.

Hospitals could use VR to model throughput within the ED and, by layering clinical and transactional data over traffic statistics, doing a much better job of boosting efficiency.

I imagine health insurers combining claims records and clinical performance data, then using VR to as a next-gen tool predict how value-based care contracting play out in certain markets.

We may even see a time when surgeons wear VR glasses and, when perplexed in mid-procedure, can summon big data-driven feedback on options that improve patient survival.

Of course, VR is just set of technologies, and it can’t offer answers to questions we don’t know to ask. However, I do think that by people using their intuition more effectively, VR-based data analysis may extract new and valuable insights from existing data sets. It may take a while for this to happen, but I believe that it will.

AI Making Doctors Better Is the Right Approach

Posted on September 6, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

This summer Bertalan Meskó, MD, PhD posted 10 ways that AI (Artificial Intelligence) could make him a better doctor. Here are his 10 ways:

1) Eradicate waiting time
2) Prioritize my emails
3) Find me the information I need
4) Keep me up-to-date
5) Work when I don’t
6) Help me make hard decisions rational
7) Help patients with urgent matters reach me
8) Help me improve over time
9) Help me collaborate more
10) Do administrative work

This is a great list of ways that AI can make doctors better. No doubt there are even more ways that we’ll discover as AI continues to improve. However, I love this list because it looks at AI from the appropriate point of reference. AI is going to be something that improves the doctor, not replaces the doctor.

I know that many people have talked about how technology is going to replace the doctor. The most famous of which is Vinod Khosla. However, you have to remember that Vinod is an investor and so he needs to drum up companies with ambitious visions. I believe his statement was as much about finding companies that will push the bounds of healthcare as much as it was his prediction for the future of healthcare. However, it no doubt created a lot of fear for doctors.

The reality is that some aspects of what a doctor does will be replaced by technology, but as the list above illustrates, that can be a very good thing for doctors.

AI is coming to healthcare. In some ways, it’s already here. However, the AI that’s coming today isn’t about replacing the doctor, it’s about making the doctor better. Honestly, any doctor that can’t embrace this idea is a doctor that shouldn’t have a medical license.

Should doctors be cautious in how quickly they adopt the technology and should they take the time to make sure that the AI won’t have adverse impacts on their patients? Absolutely. However, there’s a tipping point where not using AI is going to be much more damaging to patients than the risks that are likely to make headlines and scare many. Doctors need to be more driven by what’s best for their patients than fear inducing headlines.

AI will make doctors lives better in a wide variety of ways. It won’t replace the doctor but will enhance the doctor. That’s exciting!