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Google’s DeepMind Rolling Out Bitcoin-Like Health Record Tracking To Hospitals

Posted on May 8, 2017 I Written By

Anne Zieger is veteran healthcare editor and analyst with 25 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. She can be reached at @ziegerhealth or www.ziegerhealthcare.com.

Blockchain technology is gradually becoming part of how we think about healthcare data. Even government entities like the ONC and FDA – typically not early adopters – are throwing their hat into the blockchain ring.

In fact, according to recent research by Deloitte, healthcare and life sciences companies are planning the most aggressive blockchain deployments of any industry. Thirty-five percent of Deloitte’s respondents told the consulting firm that they expected to put blockchain into production this year.

Many companies are tackling the practical uses of blockchain tech in healthcare. But to me, few are more interesting than Google’s DeepMind, a hot new AI firm based in the UK acquired by Google a few years ago.

DeepMind has already signed an agreement with a branch of Britain’s National Health Trust, under which it will access patient data in the development healthcare app named Streams. Now, it’s launching a new project in partnership with the NHS, in which it will use a new technology based on bitcoin to let hospitals, the NHS and over time, patients track what happens to personal health data.

The new technology, known as “Verifiable Data Audit,” will create a specialized digital ledger which automatically records every time someone touches patient data, according to British newspaper The Guardian.

In a blog entry, DeepMind co-founder Mustafa Suleyman notes that the system will track not only that the data was used, but also why. In addition, the ledger supporting the audit will be set to append-only, so once the system records an activity, that record can’t be erased.

The technology differs from existing blockchain models in some important ways, however. For one thing, unlike in other blockchain models, Verifiable Data Audit won’t rely on decentralized ledger verification of a broad set of participants. The developers have assumed that trusted institutions like hospitals can be relied on to verify ledger records.

Another way in which the new technology is different is that it doesn’t use a chain infrastructure. Instead, it’s using a mathematical function known as a Merkle tree. Every time the system adds an entry to the ledger, it generates a cryptographic hash summarizing not only that latest ledger entry, but also the previous ledger values.

DeepMind is also providing a dedicated online interface which participating hospitals can use to review the audit trail compiled by the system, in real-time. In the future, the company hopes to make automated queries which would “sound the alarm” if data appeared to be compromised.

Though DeepMind does expect to give patients direct oversight over how, where and why their data has been used, they don’t expect that to happen for some time, as it’s not yet clear how to secure such access. In the mean time, participating hospitals are getting a taste of the future, one in which patients will ultimate control access to their health data assets.

FDA-Approved Digital Health Should Save $100B+ Over Next Four Years

Posted on June 8, 2015 I Written By

Anne Zieger is veteran healthcare editor and analyst with 25 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. She can be reached at @ziegerhealth or www.ziegerhealthcare.com.

Here’s some research which suggests that a lack of “medical grade” digital health tools is perhaps the final obstacle holding healthcare back adopting them full scale — and reaping the benefits.

Accenture released a study last week concluding that FDA-regulated digital health solutions should save the U.S. healthcare system more than $100 billion between now and the next four years.

The scant number of digital health solutions the FDA has already approved has already had a meaningful impact, generating $6 billion in cost savings last year courtesy of improved med adherence, fewer ED visits and digitally-supported behavior changes, Accenture reports.

But that’s just a drop in the bucket, if Accenture is right. The consulting firm expects our health system to save $10 billion this year thanks to use of such devices. And then, as the FDA approves more digital health technology, the savings figure should make dramatic jumps over the next few years, hitting $18 billion in ’16, $30 billion in ’17 and $50 billion in ’18.

What’s intriguing about these numbers is that they assume each FDA approval will seemingly generate not only more savings, but also a cumulative “whole is greater than the sum of its parts” effect.

After all, in raw numbers, the number of devices Accenture is relying on to achieve this effect is small, from 33 approved last year to 100 by the end of 2018. In other words, 67 devices will help to generate an additional $44 billion in savings.

That being said, what makes Accenture so sure that the ever-so-slow FDA will approve even 70-odd devices over the next few years?

* Provider demand:  At present, about one-quarter of U.S. doctors “routinely” use tele-monitoring devices for chronic disease management, researchers found. As hospitals and medical practices look to integrate such solutions with their core EMR infrastructure, they’ll look to please providers who want digital health tech they can trust.

Reimbursement shifts:  Accenture argues that as value-based reimbursement becomes more the norm, health leaders will increasingly see digital health solutions as a means of meeting their goals. And medical device providers will be only to happy to provide them.

Regulatory conditions: With FDA guidelines in place specifying when wellness tools like heart rate monitors become health devices, it will be easier for the FDA to speed up the process of digital health technologies, Accenture predicts. This should support 30% annual growth of such solutions through 2018, the study found.

Consumer health tracking:  Consumer demand for health tracking devices, especially wearables, should continue its rapid expansion, with the number of consumers owning a wearable fitness device to double from 22% this year to 43% by 2020, according to the consulting firm.

While Accenture doesn’t address the impact of digital health tech that doesn’t get FDA approval, there’s little doubt that it too will have a significant impact on both health outcomes and cost savings. Ultimately, though, it could be that it will take an FDA seal of approval to get widespread adoption of such technologies.

HIMSS: The FDA Should Tread Carefully With Health IT Oversight

Posted on November 12, 2013 I Written By

Anne Zieger is veteran healthcare editor and analyst with 25 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. She can be reached at @ziegerhealth or www.ziegerhealthcare.com.

Of late, the FDA has been looking at into how it will regulate health IT generally, and EMRs especially, under the authority of the Food and Drug Administration Safety Innovation Act of 2012.  This, of course, has the vendor community very nervous, as they’re not eager to have an agency as powerful as the FDA breathing down their neck.

In an effort to soften the blow somewhat, the chairman  and CEO of HIMSS  have written a letter to HHS outlining why health IT products, especially EMRs, have unique functions and requirements.

In the letter, they argue that any regulatory efforts that are made should have the following characteristics:

• Holistic Approach: Any regulatory or oversight framework should recognize that health IT is part of a complex patient care ecosystem involving providers, product developers, vendors, a  wide array of use cases, and consumers as patients and caregivers.
• Shared Responsibility: The safety and efficacy of health IT as it fits within the patient care
system can be enhanced through non-punitive surveillance and reporting systems based on mutual trust and shared responsibility by all participants.
• Clear Oversight Direction: Clear and consistent guidance regarding proposed regulatory and/or  oversight activity is essential to ensure that health IT can continue to provide the innovation and tools necessary to achieve the patient safety and quality improvement goals, and cost efficiencies sought by all stakeholders.
• Role of Intended Use/Functionality: Regulation and oversight actions should be based on the  intended purpose and intended user of a particular product or service.

Cutting a nice wide path for EMRs and related clinical data systems, HIMSS argues that health IT products largely used for transmission, storage and management of data should not be considered medical devices. The execs also argue that there’s a big difference between products which are “integral to the functioning of a medical device,” and those that communicate with such devices. (While there’s definitely a move on to integrate EMRs and medical devices, progress has been scant to date.)

We’ll see how successful HIMSS was at shaping the FDA’s expectations next year, when the agency releases a joint report outlining its strategy in cooperation with the FCC and ONC.

In the mean time, the three agencies have formed a workgroup under the ONC’s HIT  Policy Committee which will provide recommendations to the Health IT Policy Committee.  If you’re as worried as HIMSS is, and there’s no reason not to be, the workgroup may offer a chance to make your voice heard. Getting involved, or at least commenting on draft report docs, is probably a good idea.

ONC, FCC, FDA Seek Comment On Pending Health IT Regulations

Posted on June 4, 2013 I Written By

Anne Zieger is veteran healthcare editor and analyst with 25 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. She can be reached at @ziegerhealth or www.ziegerhealthcare.com.

This is big stuff, folks.  The FCC, FDA and the ONC are asking the public for comments they can use in developing a regulatory framework for health IT, according to iHealthBeat.  While the agency alphabet soup doesn’t sound very exciting on the surface, I’d argue that this is a turning point for health IT as a whole, as such a framework is likely to change the way the HIT market does business.

So why go ahead with such a request  now?  iHealthBeat reports that the request for comments cites “a growing need for the federal government to develop a coordinated approach to its oversight of health IT that promotes innovation, protects patient safety and avoids regulatory duplication.”

The report is being executed by a 32-member workgroup, housed under the ONC’s Health IT Policy Committee. It’s being tasked under the authority of the 2012 FDA Safety and Innovation Act, which requires the group to submit a report by January 2014.  One portion of the report will be dedicated to mobile health applications.

According to iHealthBeat, the request for comments covers three key areas:

  • Taxonomy, including what types of health IT the agencies should address in the report;
  • Risk and innovation, including what types of risks health IT poses to patient safety; and
  • Regulation, including what regulatory areas are overseen by more than one of the agencies and what can be done to minimize such overlap.

Commenters are encouraged to offer their in put no later than June 30, but the comment period will remain officially open until August 31.

FCC Says Wireless Health Should Be “Routine” Within Five Years

Posted on September 28, 2012 I Written By

Anne Zieger is veteran healthcare editor and analyst with 25 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. She can be reached at @ziegerhealth or www.ziegerhealthcare.com.

This week, the FCC made an announcement which, I think, is likely to have far-reaching implications, including for providers, hospitals, wireless vendors and medical device makers. *So* much is going on in this announcement that I think I’ll have to parcel it out into a series, so stay tuned.

But let’s start with the basics. In the announcement, the FCC said that it plans to implement on the key recommendations made by an independent mHealth task force.

Perhaps the most dramatic news is that the FCC seems ready to push for making mHealth “a routine medical best practice” by 2017.  Despite doctors’ increasing reliance on mobile devices, that’s a tall order — or even a nearly impossible one depending on how comprehensive your definition of mHealth is.  Regardless, this looks like a watershed moment.

The agency has already taken several steps that advance wireless healthcare networking, including:

*  Medical Body Area Networks:  The FCC recently released an order allocating spectrum for Medical Body Area Networks, networks of small sensors attached to a patient that continuously report results.

*  Medical Micropower Networks:  Last year, the FCC adopted rules enabling a next generation of  wireless medical devices used to restore functioning to paralyzed limbs. The MMN is an ultra-low-power wideband network consisting of transmitters, which are implanted in the body to take the place of damaged nerves.

FDA/FCC Partnership:  Since 2010, the FCC has been working in partnership with the FDA to help bring communications-related medical devices quickly and safely to market.

But this is just the beginning, folks. As you’ll see over following installments, the FCC is taking on not only the broad policy goal of “mHealth by 2017” but taking several steps that should help to lay the groundwork to make this happen.

Are they enough?  Let’s talk about it. I’ll get into what some of the proposals are, and how much impact they’re likely to have, in coming HospitalEMRandEHR.com articles.  So don’t turn that channel!

Consumer Health IT Tools Could Allow Self-Prescribing

Posted on March 23, 2012 I Written By

Anne Zieger is veteran healthcare editor and analyst with 25 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. She can be reached at @ziegerhealth or www.ziegerhealthcare.com.

Should patients be allowed to use online questionnaires, patient kiosks or other self-assessment technologies to determine the need for and obtain medications which now require prescriptions?  The FDA is taking up just that question this week in hearings at its DC headquarters.

The FDA is looking at ending prescription requirements for drugs used for several chronic conditions, including diabetes, asthma, high blood pressure, migraines and high cholesterol. It seems that the FDA has been paying close attention to the tech world, including movements like mobile tracking of health and the general trend toward self-assessment and consumer data collection.

According to iHealthBeat, the FDA thinks it might be a good idea to let consumers figure out whether they need certain medications by answering questions posed on a Website (a practice which, it should be noted, has been common on what are now rogue pharmaceutical sites) or perhaps respond to questions at a patient kiosk. I imagine that if enacted, such rules would apply to smartphones and tablets too.

A pharmacist from UC-San Diego quoted in the story argues that while some members of the public will be able to manage the information needed and make good decisions, others won’t. This is definitely a legitimate concern.

As I see it, though, our job in the health IT industry is to study models like these and see what failsafes we can put into to make self-prescribing as bulletproof as taking money out of an ATM machine.

It’s going to take sophisticated logic to get the right questions out there, smart machines to make inadvertent answers almost impossible, and crystal clear UIs to keep consumers oriented, but I think this has to happen.  After all, consumers are adopting health IT more and more each day. The barn door is open and the horse is running around, so let’s saddle it and leverage that energy!

A Taste of This Week’s mHealth Summit Event

Posted on December 5, 2011 I Written By

Katherine Rourke is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she’s served as editor in chief of several healthcare B2B sites.

This week, we’ll be at the mHealth Summit in DC, which should offer quite a deep dive into the emerging and critically important world of mobile health technology.  I suspect we’ll all learn something new at the event, whose keynote speakers include HHS Secretary Kathleen Sebelius, Verizon Wireless COO John Stratton and FCC Chairman Julius Genachowski.

Once in a while,  you get to attend an event which is happening at just the right time and drawing just the right people.  As I see it, this is just such a moment. Not only are EMRs and other health IT migrating to mobile devices in increasing numbers, mobile apps are working their way into mainstream use, and we’ve even seen a few mHealth apps approved for use by the FDA.

As an editor covering the show, I’ve got a lovely ringside view of the event, and I’ve been getting fascinating e-mail from vendors for weeks. A few items that caught my eye include the following:

*  Vendor BoxTone is pitching its Enterprise Mobility Management platform, designed to help IT departments provision, manage and support mobile devices and apps. I suspect hospitals aren’t paying enough to corporate level management of mobile devices yet, and if so, now is certainly the time.

* Dr. Peter Tippett, CMIO with Verizon Connected Healthcare Solutions, is co-presenting on mobility innovation in healthcare. And Verizon press  are promising to provide new healthcare mobility use cases for disease management and outline best practices for integrating identity and access management techniques into mobility strategies. I hope to hear first hand what Dr. Tippett and his colleagues have to say.

*The Continua Health Alliance is offering some interesting lectures, including one on the future of wearable mHealth apps, devices and sensors. I’ve always been surprised that these technologies aren’t more widely deployed already, but maybe I’ll learn on Tuesday at the lecture.  I’m also interested to hear what Continua folks have to say about standards in mHealth are shaking out — seems like a conversation worth having, no?

* SAP will be talking about its recently-launched mobile EMR app and its mHealth strategy generally. I’m eager to see how SAP’s existing strategy plays in this arena, which calls for fleetness of foot rather than having armies of developers at your command. Can a giant like SAP compete with nimble little mHealth app shops?  Trust me, I’ll ask.

So, folks, no mere blog item could cover the explosion of mHealth activity gearing up in DC this week, so I’ll leave you with these tidbits. I think this is going to be an exciting show.

Centricity Gets FDA 510(k) Clearance for Mobile Radiology App

Posted on December 2, 2011 I Written By

Katherine Rourke is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she’s served as editor in chief of several healthcare B2B sites.

There’s lots of interesting things doctors can do when they can access medical data on the road — and the number of options has increased rapidly over the past year or two. Until recently, though, mobile imaging apps were uncommon, for reasons that had as much to do with corporate inertia as technology.

Now, the FDA has approved another such app,  Centricity Radiology Mobile Access 2.0, for DiagnosticCT and MR Image Review. Centricity Radiology Mobile is one of the  first radiology apps to get FDA (510k) clearance. (According to mobihealthnews.com, the first radiology app to get FDA clearance was Mobile MIM, which was cleared in February.)

The newly-approved app, which  available for Android and iOS devices, comes on the heels of GE’s release of the Centricity Advance Mobile app. Centricity Advance Mobile, released this summer, is an iPad EMR app aimed at small-practice primary care docs.

Not surprisingly, Centricity Radiology Mobile works hand in glove with the Centricity PACS system, which stores one-fifth of U.S. radiology exams according to the vendor.

The app’s design makes it practical to view even complex, large images, something that’s held back remote radiology image use. And it’s a commonsense fix. Rather than fill up the mobile device’s data storage device, he system allows users to browse images remotely without having to download the data onto their phones.

Having cleared apps like these is likely to give Centricity a new edge, as few EMR vendors have gotten to this point. While Centricity has the good luck to be part of GE,  a major medical device maker thoroughly familiar with FDA regs, few of its competitors will know how to work with FDA reps or how to keep the process moving. For now, smaller EMR  vendors with no FDA clout may simply be left behind (which is something of a shame, but that’s another story).

Rest assured that we’ll be grilling EMR vendors at the upcoming mHealth Summit (Dec. 5 to Dec. 7) about their plans for new mobile apps.  We’ll let you know what we find out.

Industry Does Too Little, Too Late On HIT-Related Safety Issues

Posted on November 11, 2011 I Written By

Katherine Rourke is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she’s served as editor in chief of several healthcare B2B sites.

This week, a pair of HIT organizations — including a HIMSS-backed group and an alliance focused on HIT safety — came together to help track HIT-related patient safety problems. The two groups have broad-based vendor support, and they seem to have the right goals. Unfortunately for them, though, the HIT safety ship may have already sailed.

Participants in the current linkup include the iHealth Alliance, part of the  EHR safety group EHRevent.com run by the publishers of the Physicians’ Desk Reference, and the HIMSS EHR Association, a collection of 44 EHR vendors working together to work on key industry issues.

The safety group, which offers a quick form allowing people to report EHR-related safety concerns, is an official, federally-certified Patient Safety Organization. That gives providers the chance to report such events in a privileged, confidential manner.

That being said, regulators seem to have gotten the jump on the software folks. As some of you may know, regulators are already preparing to begin, well, regulating HIT safety results. The FDA, which issued draft guidance on mobile medical apps this summer, may cast its eye on EHRs at some point.

Another possible angle comes from the Institute of Medicine, which recently issued a report recommending that HHS create a new watchdog agency investigating health IT safety issues.  National Coordinator for Health IT Farzad Mostashari recently told reporters that his agency, the ONC, has already begun developing an EHR safety and surveillance plan which should be out within the next 12 months.

(If you want this process to be as painless as possible, you’d better hope that the IOM gets its way; vendors, you don’t want to face the kind of FDA struggles pharmaceutical companies do, right?)

Honestly, someone who’s watched regulators do their thing for decades, I’m betting this latest industry effort will be too little, too late.

Folks, as I see it the only way you’ll get the agencies off your back is to start reporting on safety issues with EMRs/EHRs and other health IT tools aggressively. But given that many organizations aren’t even at the stage where their EMR installation is stable, good luck!