Rounding up September’s start: AliveCor’s hyperkalemia detector, Apple’s ECG Watch, Tunstall Nordic’s EWII, steps towards a bionic eye, Philips licenses BATDOK, VistA’s international future

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2017/12/Lasso.jpg” thumb_width=”120″ /]AliveCor gets a fast track for its bloodless hyperkalemia (high blood potassium) detector through the FDA Breakthrough Device program. Working with doctors at the Mayo Clinic, they developed a way to read patterns in electrocardiograms (ECG/EKG) that track increasing potassium levels without drawing blood. While attributed in the CNBC article to AI, it seems closer to machine learning. Hyperkalemia is a condition that is seen in type 1 diabetes, chronic kidney disease, and other kidney related conditions. The device and software is at least one year away from approval including a clinical trial, even on this program which further speeds up the Expedited Access Pathways (EAP) program under the 21st Century Cures legislation. AliveCor currently markets the Kardia Band that reads ECGs.

Meanwhile, the Series 4 iteration of the Apple Watch moves further into the medical device area–and AliveCor’s ECG niche–with a built-in atrial fibrillation-detecting algorithm and an ECG, along with fall detection via the new accelerometer and gyroscope. The Apple Watch will start shipping September 21. Mobihealthnews.

Danish energy and broadband provider EWII has sold its subsidiary EWII Telecare A/S to Tunstall Nordic. EWII Telecare provides telemedicine and telehealth services on a tablet platform dubbed Netcare (video here). The EWII Telecare website is already down. Telecompaper, Tunstall Nordic release

Foundational technology for a bionic eye? The University of Minnesota has developed a method using 3D printing to create light receptors on a hemispherical surface. Printing a base of silver ink, the next layer was photodiodes of a semiconducting polymer which convert light into electricity. ZDNet

Philips Healthcare is licensing the Battlefield Airmen Trauma Distributed Observation Kit (BATDOK) technology for remote monitoring of vital signs by combat paramedics. Terms were not disclosed. BATDOK was developed by the US Air Force Research Laboratory, which sought commercialization. [TTA 6 Sept 17]  Mobihealthnews

What is generally not known about the VA’s eventually departing EHR is that it has for some years an open source version called OSEHRA VistA. Plan VI will expand VistA capability by making it compatible with different languages using Unicode and creating a reference implementation for global use. Working with non-profit OSEHRA are research groups in South Korea, China, and the Kingdom of Jordan. Release

VA moves closer to doing Cerner EHR deal, real Choice for veterans (updated)

The Cerner EHR deal with the VA edges closer to closing. Another VA contractor, MITRE, reviewed the agreement and recommended 50 changes that, according to POLITICO Morning eHealth’s source, address many of the interoperability-related usability features “that irritate EHR users” such as reconciling data coming from outside sources (Home Telehealth, perhaps?–Ed.). VA officially updated the status with Congressional Veterans Affairs staff on Tuesday. The deal could be inked as early as next week, but never bet on this when the Secretary seems doubtful of the agreement date. In any case, it will be a decade before VA is fully transitioned from VistA. Speaking of the Secretary, Dr. Shulkin’s crisis of last week seems to have passed with a White House vote of confidence. He can ‘cashier’ his critics and according to him, everyone’s on board with a clear direction. We’ll see. 

Updated. Well, it’s 2 March and still no word on closing the Cerner contract. Meanwhile, the VA ‘revolt’ continues, with either true or false reports of demands for Dr. Shulkin’s resignation. It’s exhausting, and meanwhile who pays? Staff and veterans. See POLITICO from 1 March here.

Modern Healthcare reported that important reforms in the VA Choice legislation are closer to reality with the Senate Veterans Affairs committee. They are proposing changes, supported by the White House, that would open up VA Choice eligibility to nearly all veterans by “making VA facilities responsible for meeting access standards set by the VA secretary. If a facility can’t, the patient can seek out a community provider if both patient and a VA provider or an authorized provider in the community working closely with VA deem that a better option than a VA facility.” This is a step beyond the earlier proposed access standards which would have given the VA Secretary discretion to relax restrictions to community care provision. Currently the VA Choice program is used by only 1 million veterans who have to prove that they are facing wait times of 30 days or more, or 40-mile travel time to a VA clinic. While the tone in the article is slightly disparaging, firm standards and opening the VA to limited market pressures to this Editor is a good thing–and getting effective care faster to veterans, many of whom live in exurban or rural areas, is beyond all considerations, absolutely necessary. How this affects veterans monitored by telehealth programs–and interoperability of their records–are open questions.

VA’s Shulkin: Cerner rollout start by mid-2019?

An interesting short (free) article on POLITICO Morning eHealth today was an interview with VA Secretary David Shulkin, MD on the Cerner transition, stating that if all went well with negotiations later this year, VA clinicians could be using the Cerner system by mid-2019. “There’s a lot of understandable concern about whether the Cerner EHR will have the same functionality as VistA, which has evolved to the physician’s needs over the past 35 years.” One of the problems with VistA was that it wasn’t one system, it was 130 systems, which is echoed in many EHRs. POLITICO goes on to quote Dr. Shulkin: “I don’t hear as many concerns about that as I do relief about finally making a decision because people felt this was the slow death of a system that they have poured their hearts and souls into. Knowing we’re committed to doing a transition as well as we can is reassuring to people.” Sadly, the rest of the interview is paywalled on POLITICO PRO. Earlier analysis: VA says goodbye to VistA, hello to Cerner. We wonder what the involvement and engagement of the four Home Telehealth winners of the 5-year contract will be.

VA says goodbye to VistA, hello to Cerner for new EHR–and possible impacts (updated)

The new sheriff just turned the town upside down. Veterans Affairs’ new Secretary, Dr. David J. Shulkin, as expected moved quickly on the VA’s EHR modernization before the July 1 deadline, and moved to the same vendor that the Department of Defense (DoD) chose in 2015 for the Military Health System, Cerner. VA will adapt MHS GENESIS, based on Cerner Millenium. The rationale is seamless interoperability both with DoD and with private sector community providers and vendors, which base their services on commercial EHRs. The goal is to have one record for a service member through his or her lifetime and to eliminate the transition gap after discharge or retirement. (Transition gaps are also repeated when reservists or National Guard are called up for active duty then returned to their former status.) Another priority for VA is preventing the high rate of suicide among vulnerable veterans.

Updates: VA confirmed that Epic and Leidos will keep the development of the online medical appointment scheduling program, awarded in 2015 and currently in pilot, to be completed in 18 months. The contract is worth $624 million over five years. Wisconsin State Journal  The House Appropriations subcommittee on Veterans Affairs likes the Cerner EHR change. The Senate Veterans Affairs Committee is meeting Wednesday to discuss the VA budget sans the EHR transition. The EHR numbers are expected to be sooner rather than later. POLITICO Morning eHealth 

Dr. Shulkin is well acquainted with the extreme need for a modernized, interoperable system serving the Veterans Health Administration (VHA), having been on the US Senate Hot Grill for some years as Undersecretary of Health for VA. The foundation for the move from homegrown VistA to Cerner was laid last year during the prior Administration through an August RFI for a COTS (commercial off the shelf) EHR [TTA 12 Aug 16] and in later hearings. “Software development is not a core competency of VA” and it has been obvious in system breakdowns like scheduling, maintaining cybersecurity and the complex interoperability between two different systems. To move to Cerner immediately without a competition, which took DoD over two years, Dr. Shulkin used his authority to sign a “Determination and Findings” (D&F) which provides for a public health exception to the bidding process. The value of the Cerner contract will not be determined for several months.

For those sentimental about VistA, he acknowledged the pioneering role of the EHR back in the 1970s, but that calls for modernization started in 2000 with seven ‘blue ribbon’ commissions and innumerable Congressional hearings since. He understated the cost in the failed efforts on interoperability with DoD’s own AHLTA system, VA’s own effort at a new architecture, and modernizing the outpatient system. This Editor tallied these three alone at $3 billion in GAO’s reckoning [‘Pondering the Squandering’, TTA 27 July 13]. 

It is still going to take years to implement–no quick fixes in something this massive, despite the urgency.

  • Both MHS and VA will be running two systems at once for years (more…)

VA Digital Health Platform proof-of-concept unveiled; new VA head nominated

Back in April 2016, the Department of Veterans Affairs (VA) in Congressional hearings hinted at an end of year preview of a ‘state-of-the-art’ digital health platform which would integrate veteran health information from multiple sources. That debut was revealed this week in analytics vendor Apervita‘s announcement that they are participating in a proof-of-concept of the VA Digital Health Platform (DHP). According to their release, in the first three weeks, they and the DHP partners demonstrated that they could organize and extract insights from veteran data originating from VA, military, and commercial electronic health records, plus e-prescribing, apps, devices, and wearables. The end outcome is to provide a unified view or dashboard that integrates data, implements a care plan, tracks clinical encounters, optimizes medications, responds to patient needs, and more. The prime contractor in DHP is Georgia Tech, which brought on board Apervita, Salesforce (workflow user engagement), and MuleSoft (API). Next steps are not disclosed. Mobihealthnews, Health Data Management

One of the sparkplugs behind the DHP and also interoperability of DOD’s and VA’s badly outdated VISTA EHR is current VA Undersecretary for Health David Shulkin, MD. Today, at an eventful press conference, President-Elect Donald J. Trump nominated him for the VA secretary position. Dr Shulkin was previously CEO of Beth Israel Medical Center in NYC and president of the Atlantic Health System ACO. He will also be, upon Senate approval, the first non-veteran head of the VA. What is apparent is that P-E Trump has not moved one iota from the promise he made during the campaign to move fast on modernizing, improving quality and speeding up veterans health services–and for that he needs an insider.  Health Data Management

VA’s moves spell the end of the homegrown EHR

The Veterans Health Administration (VHA) is formally reaching out to the private sector to explore switching from its current, pioneering EHR system, VistA (also referred to as CPRS, Computerized Patient Record System) to a commercial system. Their ‘feeler’ is an August 5 and 8 notice in FedBizOpps.gov titled 99–TAC-16-37877 * RFI – VHA supporting COTS EHR REQUEST FOR INFORMATION (RFI), Solicitation Number: VA11816N1486. This requests information on business support for transitioning to a commercial-off-the-shelf system (COTS–don’t governments love acronyms?–Ed.) and closes 26 August, which is not a lot of time even for an RFI.

VHA has been under extreme pressure from Congress to modernize its EHR, lately in July hearings before the Senate Appropriations Committee. EHR replacement is also in line with the Congressionally-mandated, now concluded Commission on Care’s recently published recommendations on a total, top-down reorganization of VHA, including a sweeping reorg of their HIT management. The VHA strategy appears to be that while they are walking down the road to replace VistA and have already spent to assess where they are with KLAS and other EHR consultancies (spending $160,000+ on surveys), they are essentially ‘kicking the can down the road’ to the next administration (POLITICO’s Morning eHealth, 14 July).

Current state is to continue to upgrade VistA through late 2018, though the closely related Department of Defense’s Military Health System is in the long process of cutting its homegrown AHLTA over to Cerner-Leidos as MHS Genesis, awarded last August, with a first trial in the Pacific Northwest later this year (HealthcareITNews, Ed. emphasis). Of course, it will take the VHA years to roll it out; there are close to 9 million veterans enrolled in the closed system that is the VHA.  FCW, Morning eHealth 10 August

Love EHRs or hate them, the sheer size of the VHA and its growing concession that VistA won’t do in caring for American veterans makes it clear that the future of EHRs is in private systems from major developers–a field which is winnowing out to The Few (take that, GE).  (more…)

A weekend potpourri of health tech news: mergers, cyber-ransom, Obama as VC?

As we approach what we in these less-than-United States think of as the quarter-mile of the summer (our Independence Day holiday), and while vacations and picnics are top of mind, there’s a lot of news from all over which this Editor will touch on, gently (well, maybe not so gently). Grab that hot dog and soda, and read on….

Split decision probable for US insurer mergers. The Aetna-Humana and Anthem-Cigna mergers will reduce the Big 5 to the Big 3, leading to much controversy on both the Federal and state levels. While state department of insurance opposition cannot scupper the deals, smaller states such as Missouri and the recent split decision from California on Aetna-Humana (the insurance commissioner said no, the managed care department said OK) plus the no on the smaller Anthem-Cigna merger are influential. There’s an already reluctant Department of Justice anti-trust division and a US Senate antitrust subcommittee heavily influenced by a liberal think tank’s (Center for American Progress) report back in March. Divestment may not solve all their problems. Doctors don’t like it. Anthem-Cigna have also had public disagreements concerning their merged future management and governance, but the betting line indicates they will be the sacrificial lamb anyway. Healthcare Dive today,  Healthcare Dive, CT Mirror, WSJ (may be paywalled) Editor’s prediction: an even tougher reimbursement road for most of RPM and other health tech as four companies will be in Musical Chairs-ville for years.

‘thedarkoverlord’ allegedly holding 9.3 million insurance records for cyber-ransom. 750 bitcoins, or about $485,000 is the reputed price in the DeepDotWeb report. Allegedly the names, DOBs and SSNs were lifted from a major insurance company in plain text. This appears to be in addition to 655,000 patient records from healthcare organizations in Georgia and the Midwest for sale for 151 – 607 bitcoins or $100,000 – $395,000. The hacker promises ‘we’re just getting started’ and recommends that these organizations ‘take the offer’. Leave the gun, take the cannoli.  HealthcareITNews  It makes the 4,300 record breach at Massachusetts General via the typical unauthorized access at a third party, once something noteworthy, look like small potatoes in comparison. HealthcareITNews  Further reading on hardening systems by focusing on removing admin rights, whitelisting and endpoint security. HealthcareDataManagement

Should VistA stay or go? It looks like this granddaddy of all EHRs used by the US Veterans Health Administration will be sunsetted around 2018, but even their undersecretary for health and their CIO seem to be ambivalent in last week’s Congressional hearings. According to POLITICO’s Morning eHealth newsletter, “The agency will be sticking with its homegrown software through 2018, at which point the VA will start creating a cloud-based platform that may include VistA elements at its core, an agency spokesman explained.” Supposedly even VA insiders are puzzled as to what that means, and some key Senators are losing patience. VistA covers 365 data centers, 130 separate VistA systems, and 834 custom installations, and is also the core of many foreign government systems and the private Medsphere OpenVista. 6/23 and 6/24

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2014/01/Overrun-by-Robots1-183×108.jpg” thumb_width=”150″ /]Dr Eric Topol grooves on ‘The Fourth Industrial Revolution’ of robotics and AI. (more…)

EHRs: now safety, info exchange concerns (US, AU, CA)

What’s this? EHRs reducing, not increasing, safety? Reports from both the US and Australia seem to indicate another spanner (US: wrench) in the EHR works, aside from the laggardness in achieving the HITECH Act’s goals [TTA 27 Mar].

  • The Joint Commission, which is the chief US accreditation and certification body for healthcare organizations and programs, and thus to be taken very VERY seriously, released a Sentinel Event (Patient Safety Event) Alert yesterday. It warned of EHR-related adverse events affecting patient health, resulting from incorrect or miscommunicated information entered into EHRs. Interfaces built into the technology can contribute and studies have documented mixed results in the systems’ ability to detect and prevent errors. It identifies eight key factors,led by human-computer interface, workflow and communication and clinical content, that can lead to a sentinel event and three major remedy actions. While the JC does take pains to confirm the positive effects of well-designed and appropriately used EHRs, with strong clinical processes in place, it is the first ‘red flag’ this Editor can recall (more…)

VA, DoD aren’t collaborating on EHR: GAO

Your ‘Dog Bites Man’ item for the weekend (no, it’s not in reverse!) is that the Government Accountability Office (GAO) has determined that Veterans Affairs (VA) and the Department of Defense (DoD) have not yet proved that their current two-system path, having rejected a single EHR, actually will be workable. In February 2013, both agencies abandoned a joint system after $1 billion in spend, and $4 billion in fixes/upgrades to their separate VistA and AHLTA systems. [TTA 15 Dec] By the two agencies going their separate ways, the GAO is mystified on what is going on with interoperability. The answer: not much. And as mentioned in our 15 December article, there was a 31 January deadline for an interoperability plan (or single system) to be implemented by 2016, mandated by the 2014 National Defense Authorization Act (NDAA). Obviously, this deadline has come and gone. FierceEMR article, GAO recommendation (full text PDF)

One way to overcome the interoperability problem and too much in the EHR? Get rid of those pesky backlogged patient records! The Daily Caller uncovered a VA whistleblower’s complaint to the VA’s Inspector General and their office of special counsel, plus Congress, that VA officials in Los Angeles intentionally canceled backlogged patient exam requests going back more than one year–and that the delay on exams went back 6-9 months. The deletions started in 2009. There is a wrongful dismissal (of said whistleblower) suit and other joy. Article, audio (02:21) Updates 3-4 March:  according to Under Secretary for Health Robert Petzel, the Daily Caller report was ‘scurrilous’. He stated that about 300 records were closed but not deleted after administrative review, generally for old imaging requests, and there was no effort to delete records to boost performance.  According to FierceHealthIT, the backlog is about 400,000. Also Military Times. According to EHR Intelligence, both DoD and the VA agree with the GAO recommendations; GAO will update its findings once the agencies have taken action. Also iHealthBeat.

EHR interoperability redux for VA, Department of Defense (US)

Back in late February, the US Department of Defense and Veterans Affairs announced that they would not achieve their goal of a single EHR by 2017, and would stick with their creaky AHLTA and VistA systems for the foreseeable future [TTA 3 April]–along with the general lack of interoperability–eyes rolled at the $1 billion down the drain, but seemingly not much else budged. (And this does not include the $4 billion spent on failed updates and fixes in both systems–TTA’s ‘Pondering the Squandering’, 27 July) To this Editor’s utter shock, the 2014 National Defense Authorization Act (NDAA), agreed to by the House and Senate this week, mandates a plan for either interoperability or a single system by 31 January–about 6 weeks from now–and to adopt it by 2016. Moreover, both systems must be interoperable with private providers based on national standards by 1 October 2014. A close reading of the NextGov article indicates that the bill adds levels of complexity and perhaps unworkability. Getthereitis, anyone?–or does this sound like Healthcare.gov, redux? FierceMobileHealthcare

And it takes a grad student to find a major info security flaw in VistA.  (more…)

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?  

Pondering the squandering of taxpayer money on IT projects (US)

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2013/02/gimlet-eye.jpg” thumb_width=”150″ /]The Gimlet Eye has been in Observation Mode this week. But this handful of Dust-In-Eye necessitates a Benny Goodman-style Ray on another US governmental ‘fail’. When it comes to IT, the government admits…

Agencies Have Spent Billions on Failed and Poorly Performing Investments

Exhibit #1: FierceHealthIT summarizes five big ones out of a 51-page Government Accountability Office (GAO) report focusing on the inefficiency of agency IT initiatives–just in healthcare.

  1. Veterans Affairs (VA) VistA EHR system transitioning to a new architecture: terminated October 2010 at a cost of $1.9 billion
  2. VA-Department of Defense (DOD) iEHR integration: as previously written about, it collapsed under its own weight for another $1 billion [TTA 8 March]
  3. DoD-VA’s Federal Health Care Center (FHCC). Opened in 2010 as a joint facility under a single authority line, but somehow none of the IT capabilities were up and running when the doors opened. ‘Jake, it’s ChiTown.’ Only $122 million.

  4. DoD’s own EHR, AHLTA (no VistA–that’s VA’s) still doesn’t work right; speed, usability and availability all problematic. A mere $2 billion over 13 years.
  5. VA’s outpatient system is 25 years old. Modernization failed after $127 million over 9 years before the plug was pulled in September 2009

You’ll need Iron Eyes to slog through the detail, but it is a remarkable and damning document. PDF (link)

but…there’s more. Excruciating, hair-hurting, and would be amusing if not so painfully, and expensively, inept. Malware Removal Gone Wild at Commerce(more…)