Want to attract Google Ventures to your health tech? Look to these seven areas.

The GV Hot 7, especially the finally-acknowledged physician burnout. Google Ventures’ (GV) Dr. Krishna Yeshwant, a GV general partner leading the Life Sciences team, is interested in seven areas, according to his interview in Business Insider (UK):

  • Physician burnout, which has become epidemic as doctors (and nurses) spend more and more time with their EHRs versus patients. This is Job #1 in this Editor’s opinion.

Dr. Yeshwant’s run-on question to be solved is: “Where are the places where we can intervene to continue getting the advantages of the electronic medical record while respecting the fact that there’s a human relationship that most people have gotten into this for that’s been eroded by the fact that there’s now a computer that’s a core part of the conversation.” (Your job–parse this sentence!–Ed.)

Let’s turn to Dr. Robert Wachter for a better statement of the problem. This Editor was present for his talk at the NYeC Digital Health Conference [TTA 19 Jan] and these are quoted from his slides: “Burnout is associated with computerized order entry use and perceived ‘clerical burden’ [of EHRs and other systems]”. He also cites the digital squeeze on physicians and the Productivity Paradox, noted by economist Robert Solow as “You can see the computer age everywhere except in the productivity statistics.” In other words, EHRs are a major thief of time. What needs to happen? “Improvements in the technology and reimagining the work itself.” Citing Mr. Solow again, the Productivity Paradox in healthcare will take 15-20 years to resolve. Dr. Wachter’s talk is here. (more…)

ATA 2017 dispatch: Devices and doom

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/09/Drowning-in-paper.jpg” thumb_width=”150″ /]Bruce Judson, our guest ATA 2017/Telehealth 2.0 reporter, is a bestselling author of books on business and technology issues in the evolving digital era. This is the third and final article this week he’s written from the ATA floor. Mr. Judson writes frequently for The Huffington Post. More on about him may be found in our review of his critique of the RAND telehealth study [25 Mar].

This Editor agrees with his POV that drowning doctors in more and more data, whether previously accessible or not, isn’t a way forward to a successful business model. The current data is overwhelming–and not interoperable with EHRs. More and more data, looking for a home….

Orlando, April 26. Yesterday, I set aside several hours to walk by the booths of the 200+ exhibitors at the ATA show. As I slowly walked the Exhibit Hall, I was struck by the large number of in-home telehealth patient monitoring devices. (Names are omitted to protect the innocent.)

Colleagues had similar reactions. When I asked about exhibitors, the most common response was “I had no idea there were so many new telehealth monitoring devices that are FDA approved or in the process of obtaining approval.”

As I wandered from booth to booth, I was also struck by the failure of so many, if not most, monitoring device manufacturers to focus on the practical uses of their truly revolutionary technologies. At each monitoring device booth, I asked the same question, “How will the data be used?”  All too often, the answer was, “We provide daily patient data for physicians that have never been accessible before, and doctors receive daily graphs.”

My follow-up questions were always, “You believe busy doctors will look at data on their large patient population each day? Why don’t you provide alerts?” Again, there was a frequent answer, which was some variation of “Yes, now doctors can see daily events which will lead to extraordinary improvements in health outcomes, and we don’t want to create alert fatigue” (false positives that suggest a problem where one does not exist).

In my view, monitoring devices without suites of robust predictive analytics will fail. Doctors are already too busy, and anything that adds to their workload is immediately suspect. Moreover, we still live in a fee for service world, and now we are talking about new, uncompensated work.

As Jonathan Linkous said to me on the first day of the ATA show, “the technology is a tool to provide the service,” not the service itself. Patient monitoring device firms must realize they are offering a service. To succeed, their services must provide actionable analysis, not more and more data. If alerts are ready for prime time, then doctors will value the devices: They can rely on the associated algorithms to indicate when an intervention (also to be compensated) is needed.

Moreover, I strongly suspect doctors would prefer a few false alerts, with algorithms biased toward safety and results that can be quickly checked via the underlying data, as compared to wading through charts looking for anomalies.

A fundamental question for anyone is “what business are you really in?” To succeed, many of the ATA exhibitors need to reorient themselves from the business of providing great technology to the business of providing great service enabled by technology.

Mr. Judson’s first article, a discussion with ATA’s Jonathan Linkous on business models for telehealth is here. The second article on Mercy Health’s catalyzing telehealth innovation at the hospital level is here.

A ‘top 50’ of 2016 US health tech, med tech conferences

An unusually diverse list of conferences on health/medical technology and medical devices has been compiled by Pannam Imaging, which manufactures complex, mid-to-low volume integrated human-machine interfaces of use in several industries including healthcare technology. Many focus on medical devices, life sciences and biotech (BIO International in June) but some are on cybersecurity–and d.Health Summit (the d. is for disruptive) on 4 May in NYC is new to this Editor. Are all of them worth attending? Depends on your interest and market, but it’s not the usual suspects. Top MedTech Conferences: 50 Conferences on Health Tech, Medical Devices, and Medical Technology Worth Attending in 2016

FDA, new technology approval and the Ossification Tango (US)

When it comes to new technologies–and drugs for that matter–the worst thing that can happen to your invention is to receive a letter from FDA that you have been classified into Class III. Based on regulations passed by Congress in 1976, there are three FDA classes primarily based on device risk. Exception: Class III. Anything not ‘substantially equivalent’ to an existing device is automatically put into Class III, regardless of risk level. Author and health tech legal advocate Bradley Merrill Thompson of Epstein Becker Green takes a comprehensive review at this flawed and outdated system that puts groundbreaking health tech at an extreme disadvantage in his latest article on regulation in Mobihealthnews. (more…)

Medtronic, Covidien and what it might mean for digital health

“This acquisition will allow Medtronic to reach more patients, in more ways and in more places,” Medtronic Chairman and CEO Omar Ishrak

Cover the Earth? While the healthy Medtronic offer ($42.9 billion in cash and stock) for Ireland-headquartered Covidien plc is not a ‘digital health deal’, it does point to Medtronic’s strategy which includes digital health. There is of course the obvious: growth by acquisition and integration. Acquisitions require cash, and the highly controversial change of domicile to Ireland via ‘tax inversion’ will fatten the exchequer in two ways. First is through the lower overall Irish corporate tax versus the 35 percent US tax, one of the highest in the world. Second is much more flexibility in repatriating plentiful foreign earnings at lower Irish corporate rates rather than the high US rates which Medtronic has avoided. Third is increasing dividends, which can drive up stock price and investor interest. Of interest to the latter is also that Covidien adds horizontal (and global) competitive strength to Medtronic in the clinical area–surgical, vascular, respiratory and wound care.

More Ways-More Places. Not just staples and sutures, Covidien has developed its own advanced in-hospital mobile patient monitoring in Vital Sync as well as several hospital monitoring devices in their Nellcor line. In addition to technology collaboration, the next point of integration could then be with Medtronic’s post-acute telehealth devices from Cardiocom, purchased less than one year ago. We noted at the time that it gave Medtronic entreé into the “chronic condition management continuum– not only into telehealth via Cardiocom’s devices and hubs, but also their clinical and care management systems.”

Approval will take time. Both the US and UK, through various regulatory agencies, scuppered the Pfizer-AstraZeneca deal on similar tax domiciling and competitive grounds. If it does go through, there will be a lot of reorganization. But while it digests, this Editor will be watching Medtronic for its usual pattern of making smaller ‘more ways/more places’ deals in the interim with an eye to diversifying past US-taxable medical devices. One pointer is their just-announced partnering with Sanofi to develop drug delivery-medical device combinations and care management services for diabetes patients (MedCityNews).

Related reading: Medtronic hints at more acquisitions following $43 billion Covidien deal (MedCityNews); The Medtronic, Covidien Inversion Deal Is More About Dividends Than Tax (Forbes); Medtronic agrees to buy Covidien for $42.9b in cash, stock (Boston Globe); Medtronic’s $43B Covidien deal—and Irish tax move (CNBC)

 

FDA finally issues proposed rule simplifying medical device classification

The FDA has now published its proposed rule simplifying its medical device classifications as directed by the 2012 FDA Safety and Innovation Act (FDASIA). This permits reclassification by administrative order versus the rulemaking (notice and comment) process. (Presumably this rule, as part of the latter process, sets up the process for the former.)  In the US, the Food, Drug & Cosmetic Act (FDC Act), which FDASIA amends, has three classifications of devices from least restricted (Class I general controls) through premarket approval (Class III).  

As published yesterday in the Federal Register, the class definitions are being amended to balance the assurance of safety and effectiveness with “the level of regulation necessary to provide such assurance should be closely tailored to the risk presented by a type of device.” The long-awaited changes are seen as highly favorable for mobile health devices and apps which for the most part do not fit neatly into the present Class I-III structure.  (more…)

Biocompatible batteries for ‘sensors of the future’

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2014/03/Dissolving-Battery.jpg” thumb_width=”300″ /] Pointer to the Future. Implantable medical sensors and devices have a main drawback–their power source. Current batteries are bulky and must be manually removed. External power transference means fairly bulky outside and inside devices.

What if the sensor and batteries could simply dissolve harmlessly in the body when no longer needed?

Research from John Rogers at the University of Illinois at Urbana-Champaign and his team first led to biodegradable (in the body) electronics in 2012, and now dissolving batteries (above). (more…)

2014: the year of reckoning for the ‘better mousetraps’

Or, the Incredible Immutability of the Gartner Hype Cycle

From Editor Donna, her take on the ‘mega-trend’ of 2014

This Editor expected that her ‘trends for next year’ article would be filled with Sensors, Wearables, Glasses, Smartwatches, 3D Printing, Tablets and Other Whiz-Bang Gizmos, with splashes of color from Continuing Crises like Healthcare.gov in the US, the NHS’ 3million lives plus ‘whither UK telecare’, various Corporate ‘Oops-ses’, IP/Patent Trolls and Assaults on Privacy. While these will continue to spread like storm debris on the beach, providing continuing fodder for your Editors (and The Gimlet Eye) to pick through, speculate and opine on, what in my view rises above–or is under it all–for 2014?

We are whipping past the 2012-13 Peak of Inflated Expectations in health tech…

…diving into the Trough of Disillusionment in 2014. Crystallizing this certainty (more…)

Dick Cheney’s defibrillator and medical device hacking

The news this week that former US Vice President Dick Cheney and his cardiologist decided to turn off wireless access to his implanted defibrillator (ICD) in 2007 based on fears of radio-based attacks underlines the increased awareness of security threats to wireless interfacing or programmable devices. The fear of ‘death by malicious hacking’ could very well lessen the sales and acceptance of new wireless-dependent designs in pacemakers, diabetes management/artificial pancreas and even medication ingestion tracking (Proteus). One proposal outlined in medical device supplier blog Qmed is interesting: “Since most proposed attacks would take place from a distance, researchers believe that using a patient’s heartbeat signature as a password could offer an adequate level of security. Using a heartbeat signature password, pacemakers and other devices would only unlock when “fed back” an individual’s heartbeat in real time.”  Yet beyond that, an advanced ‘white hat’ hacker like the late Barnaby Jack envisioned bugs in programming which could negate this to create murdering pacemakers as well as killer insulin pumps. (A look back at Barnaby and his still mysterious death in the Daily MailDick Cheney: Heart implant attack was credible (BBC News) Hat tip to TANN Ireland’s Toni Bunting. Previously in TTA: A ‘mobilized’ artificial pancreas breakthrough included the increased awareness of hack attacks in the medical mainstream and Contributing Editor Charles on compromised smartphone apps.

US government takes a pause, medical device tax repeal effort does not

The partial shutdown (except essential services) of the Federal Government due to the missed budget deadline will mean some suspension of services and furloughed people (with the far more important debt limit/default deadline looming in mid-October)–but no year long postponement of the unready-for-prime time Affordable Care Act (ACA). What is surprising is the bi-partisan support, separate from the budget wrangle, for eliminating the medical device excise tax, (more…)

FDA publishes medical device interoperability standards (US)

While FDA is still dithering about issuing draft guidance on mHealth, it looks like medical device manufacturers can break out the champs, because FDA has now recognized 25 standards on medical device interoperability and cybersecurity. According to Bakul Patel of the Center for Devices and Radiological Health at FDA, “Making sure devices are interoperable requires the creation, validation, and recognition of standards that help manufacturers develop products that are harmonious and can “plug and play.” It’s an alphabet soup of industry standard abbreviations–IEEE, ANSI, AAMI, ISO, IEC and ASTM–and it’s purely voluntary, but various groups such as Continua and AAMI (Association for the Advancement of Medical Instrumentation) have praised this ‘first step’, and being published, it is now open for comment.

According to the Continua LinkedIn group announcement from Executive Director Chuck Parker, the 25 standards can be grouped into three categories:

  1. Risk management standards for a connected and networked environment
  2. Interoperability standards that establish nomenclature, frameworks and medical device specific communications and including system and software lifecycle processes
  3. Cyber security standards from the industrial control area most relevant to medical devices.

As the FierceHealthIT article cited, interoperability failure is a top 10 health technology hazard according to the ECRI Institute.  One can hope the new standards can be applied retroactively to current devices which are not being patched and updated because manufacturers fear running afoul of FDA clearance regulations and counter that ‘discouragement’. [TTA 8 AugAAMI News, Federal Register 6 August, FDA Voice (blog article by Bakul Patel)

Systems sharing data, still behaving badly

A straight-shooting article in Healthcare Technology Online provides a overview of the EHR and Health Information Exchange (HIE) mess in the US. Essentially our major EHR systems (Cerner, McKesson, athenahealth, Greenway, Epic) don’t interchange data well, if at all–and the 600-odd practice EHRs were built on siloed designs, existing software and used proprietary formats, often in a rush to take advantage of Federal subsidy programs in Stage 1 Meaningful Use–as HTO’s EIC Ken Congdon stated, “electronic filing cabinets”–and heavily outsourced. Well, it’s now ‘uh-oh’ time as a key part of Stage 2 MU is interoperability. Basically we now have a set of what this Editor would term ‘paste ons’ and ‘add-ins’ to facilitate data exchange between systems that speak different languages (Editor’s emphasis):

direct protocol (a standards-based method for allowing participants to send authenticated and secure messages via the National Health Information Network), as well as those developed by HL7 (Health Level Seven), a nonprofit global health IT standards organization, provide EHR users with the building blocks for exchanging data. Blue Button, an application developed by the VA that allows patients to download their own health records, is also being adopted and manipulated by EHR vendors and independent developers as a way for providers to exchange data between systems. Moreover, regional and state-run HIEs offer healthcare providers in several parts of the country a network they can join (and technology infrastructure they can leverage) to share health data with other HIE members.

Some systems work well–EHR and pharmacy systems seem to. However, EHR to EHR interfaces are up to the provider and are expensive. Sharing/translation does not mean that all information makes it over without getting ‘bruised’ or having to be reentered manually.  HIEs, acting as a focal point for data exchange, are also generally non-profit; the exchange platforms cost millions to develop and further millions to maintain–and buy-in is low, as the article states. Fixing The EHR Interoperability Mess (free registration may be required)

(Updated 8/7 pm for Editor Donna’s POV) This is what happens when you rush adoption and development processes that should take years in order to gain quick subsidy money, and non-healthcare entities (that is you, the US Government) encouraged this, distorting the process. The private and public waste of scarce healthcare funds is appalling, and the disruption to the healthcare system is unforgivable–especially in practices where doctors and managers in many cases have been sold a bill of goods, and they are revolting by changing EHRs, going back to paper or retiring. And the Government should look to itself first. Look no further than to the multiple failures of two branches of the US government, Veterans Affairs and Department of Defense, which have the responsibility for current and veteran members of our Armed Services. They have failed spectacularly in serving Those Who Have Served not only the integration of their two EHRs but also in updating their basic architecture [TTA 27 July ‘Pondering the Squandering’… and 3 Apr ‘Behind the Magic 8 Ball’ both review the sad details.] The belief that HIEs with limited funding will solve the interoperability problem is Magic Thinking. At least one move in this direction makes sense: the CommonWell Alliance of six EHR heavy hitters to work on ‘data liquidity’ [TTA 5 Mar announced at HIMSS], but this may be another ‘uh-oh’ and face saving.

With basic, necessary health and patient information stuck in systems and getting lost in translation, how can anyone rationally expect that personal data from telehealth devices will be integrated anytime soon, in any meaningful way? Does this mean that parallel, separate systems and platforms will continue to develop–and yet another wave of integration?