News roundup: Cerner goes live at VA, DOD Lovell Center; WebMD expands education with Healthwise buy; Dexcom has FDA OK for OTC glucose sensor; Centene may have buyer for abandoned Charlotte HQ

March 12, 2024 | by

In news other than Walgreens and Optum/Change Healthcare–with more to come out of HIMSS in Orlando this week…

The DOD/VA Cerner EHR went live on Saturday 9 March in the Capt. James A. Lovell Federal Health Care Center (Lovell FHCC), right on scheduled time. This EHR which will serve both active duty service members in the Military Health System (MHS) and veterans through the VA is being watched closely. While MHS Genesis has been rolled out in most military health facilities in the US and overseas, the VA’s has stalled at five. As of now, Lovell is the only VA implementation planned for this year and its functionality and interoperability with MHS is under a microscope. Training has been intensive and VA reports having made many changes from the earlier implementations. The MHS Genesis team from DOD have also been a key part of the training.

VA has shown improvement with no full outages in 300+ days and with the nagging smaller incidents greatly reduced. But the VA’s deputy inspector general reported significant and dangerous faults in the Oracle Cerner Millenium medication record system only last month to the House Subcommittee on VA Technology Modernization [TTA 22 Feb]. While the fixes are in effect in the five VA locations with Millenium, Genesis at Lovell will not have them yet.

Lovell FHCC is located in north Chicago, has a combined DOD/VA staff of 3,200, and serves 75,000 patients per year: 25,000 veterans, over 10,000 TRICARE enrollees, and 30,000 Navy recruits from Great Lakes with a 300-bed main facility and clinics in the Chicago area. Federal News Network

WebMD buys health education developer Healthwise. The company’s patient education assets including content and technology that integrate into care management platforms for both health systems and payers will become part of WebMD Ignite, which was formed last April to unite Krames, also in health education, Mercury Health data analytics, Wellness Network videos, Vitals provider scheduling, in addition to Medscape and WebMD. According to the release, the combination of Krames and Healthwise will reach 650 healthcare organizations, comprising more than 50% of hospitals in the U.S. and 85% of the top 20 payers, which is a dominant market share with limited other competition such as Wellframe, owned by HealthEdge. Transaction cost, surviving name, and management/staff transitions were not disclosed.

Healthwise is unusual in that it was formed as a non-profit in Boise, Idaho in 1975. In the 2024 Best in KLAS Report, Healthwise was ranked first in health education for value-based care. While the education assets are being sold to WebMD, the non-profit will go on, according to Healthwise. Healthcare IT News (Editor’s disclaimer: Donna was a consultant for Krames on marketing projects during 2021-22, prior to Ignite.)

WebMD is also integrating into Ignite personalized medication instructions from First Databank (FDB)’s Meducation through WebMD Ignite’s Krames On FHIR platform. It will then go into prescribers’ EHRs and patient portals. FDB release

Dexcom receives FDA clearance for Stelo, the first over-the-counter (OTC) continuous glucose monitor cleared in the US. Like the prescription version, the biosensor attaches to the arm to monitor blood glucose without skin penetration and connects to a Dexcom phone app. The sensor is the same as the prescription Dexcom G7, with a battery life of about 15 days. Stelo was cleared for use by adults 18+ who have Type 2 diabetes but not on insulin therapy–over 25 million people in the US. Release is scheduled for online-only release this summer as a cash-pay purchase (cost not disclosed), with insurance reimbursement TBD over the next few years. Mobihealthnews, Healthcare Dive

Centene may be close to selling its ‘dream’ Charlotte, North Carolina headquarters building. The now near-complete 800,000-square-foot building in Charlotte’s University City would have been Centene’s East Coast HQ. It was planned by the previous CEO in 2020 to be the center of a campus with over 6,000 employees, 3,200 to be hired locally. The plan was abandoned in August 2022 due to a shrinking office-based workforce primarily in St. Louis with some in plan locations throughout the country. Cushman & Wakefield is marketing the building with word being that a single company is interested in purchase. New Class A space is reportedly relatively rare in Charlotte, though the vacancy rate in the immediate area is at 25%. There is also undeveloped land on the site that has attracted interest from a locally active multifamily developer, although that would require a rezoning. Centene purchased the land in 2020 for $19 million, not including a separate 51-acre parcel purchased later in 2020. In addition to reducing its real estate pattern, Centene has also been reducing its staff with two 2,000-person layoffs in 2023, one in the summer and the second in December.  Charlotte Business Journal, Becker’s

Short takes: Owlet Dream Sock FDA clearance; Best Buy-Mass General partner for at-home care; Amazon offers Prime members deeper One Medical discount

November 10, 2023 | by

Some really good news for Owlet. The Dream Sock finally got to the mountain top and received de novo FDA clearance for pulse oximetry. To date, it is the only over-the-counter medical pulse oximetry device for the baby market. This adds to the device’s Baby’s Live Health Readings, including pulse rate and oxygen saturation level. The platform also provides Health Notifications, which send alerts to a smartphone with lights and alarm sounds if baby’s readings fall outside of preset ranges. Existing and new Dream Sock buyers will be upgraded to the new features by end of 2023. The Dream Sock is for use with infants 1-18 months and 6 to 30 pounds. Pricing observed for the current Dream Sock is in the $300 range. Owlet release

This follows FDA clearance for the prescription BabySat in June [TTA 21 June]. That is scheduled to be introduced later this year in the US only. The non-prescription Dream Duo, which combines the Dream Sock with a baby cam, will continue to be sold. 

Financially, things have improved a lot since last year. The stock as of 11 July was restored to NYSE listing, but it required a reverse split and an 18 month compliance plan, Currently, it’s trading at about $4.80 which is NYSE compliant, up from well below $1 in June. Also in July, they hired a new president and chief revenue officer, Jonathan Harris, from recently acquired air purification system Molekule. In August, they reported a Q2 adjusted EBITDA loss of $4.3 million, narrowed substantially from prior year Q2’s $16.7 million. This was achieved on lower revenue of $13.1 million versus last year’s $18.3 million. Q1 revenue was $10.7 million. Q3 will be reported on 13 November. Release  Having followed them since the ‘telehealth for the bassinet set’ days of 2012-2013, their continued independence, and their focus on baby health, this Editor continues to wish them bonne chance.

Mass General Brigham’s hospital-to-home and home care programs get a Best Buy boost. Mass General plans to integrate Best Buy’s delivery capabilities for their Healthcare at Home program in several areas. For Home Hospital acute care, Best Buy will supply the Current Health remote patient monitoring program to build out a technology-enabled clinical delivery model that connects patients to nurses, paramedics, advanced practitioners, and physicians. For Home Care, Best Buy will supply Lively Mobile Plus personal emergency response system (PERS) and leverage out capabilities such as Geek Squad to supply Mass General Brigham (MGB) patients with delivery of home-based care and logistics management for the care team. MGB plans to introduce Best Buy as part of Home Hospital in five Boston-area acute care hospitals. The program is for patients with heart disease, chronic obstructive pulmonary disease (COPD) and infections. While their Home Care operation is stated by MGB to be the largest certified provider in New England, the Home Hospital program can presently cover only 33 patients at a time. MGB’s goal is to shift 10% of inpatient care to patients’ homes over the next five years, so expanding capacity and capabilities are critical. FierceHealthcare, Mobihealthnews, MGB release

Get your One Medical now, just $99 per year or $9 a month! It’s an offer hard to refuse for Amazon Prime members. It’s half off the annual membership of $199, with additional members up to five for only $6 a month or $66 annually. What Prime members get is 24/7 virtual care access without further charge through their app that includes video chats with licensed providers plus their “Treat Me Now” service, fast care for common issues like cold and flu, skin issues, allergies, and urinary tract infections. It does not include any One Medical in-office services, if available in the member’s area. The 200 million+ Prime members were briefly offered in February a $144 membership but apparently this new incentive is not only at a deeper discount, but also longer term or permanent.

Time to make that $3.9 billion acquisition pay off. This push is clearly to build up One Medical membership, which stood at only 836,000 members at end of 2022, and build up cash flow. Amazon is not reporting on the success of the earlier discount offer. A question this Editor has–if 1 million Prime members signed up–that’s only a 0.5% rate–does One Medical have the telehealth capacity to serve these patients, especially at peak usage such as cold and flu season?

Prime members are also able to access Amazon Care, which is virtual only, cash-only by medical event asynchronous telehealth services. If a Prime member goes in person to a One Medical practice, they do take insurance. FierceHealthcare, Healthcare Dive, Amazon Prime offer page

Short takes: FDA seeks feedback on home care tech; Japan care homes piloting AI; Author Health’s $115M bet on senior mental health; Alertacall’s Batchelor on ‘right fit’ finance support; Headspace in the wrong (layoff) space again

July 7, 2023 | by

Short takes for a short (US) week

FDA seeks public comment on home care tech–an opportunity for developers and home care. The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has a request for public comment on technologies that could improve home care, both in the traditional sense and in hospital-to-home transitional care. Their two key questions of nine are: “How can the FDA support the development of medical technologies, including digital health technologies and diagnostics, for use in non-clinical care settings, such as at home?” and “What factors should be considered to effectively institute patient care that includes home-based care?” The FDA’s language around this is anodyne as couched in ‘health equity’ but it’s seriously around increasing access to all, supporting innovation, reducing barriers to care, and empowering people to make better decisions around their health. All public comments must be submitted to FDA’s docket (FDA-2023-N-1956), available at Regulations.gov. Important–the public comment period will end on 30 August 2023. Healthcare Dive

In Japan, a nursing home operator/insurer is adopting analytics to track residents and reduce caregiver workload. The operator/insurer is Sompo Holdings (LinkedIn) and the analytics company is Palantir. The jointly designed software platform, egaku, integrates artificial intelligence and analytics with proprietary data on sleep, diet, medical treatment, and exercise. Sompo Care uses minimally intrusive devices such as sensor-equipped beds to evaluate sleep conditions via tracking of body movements, respiration, and heart rate. They are claiming a 15% reduction of caregiver workload in a typical 60-person capacity care facility, saving as much as $60,000 annually. Unfortunately, the FT article is paywalled but a partial citation is available on ACM TechNews   On the Palantir website, there is a fragmentary article on how Sompo used the Palantir Foundry platform to streamline gathering information for care plans by linking local resident data t0 additional care data to create ‘a single source of truth’. Sompo press release

Speaking of seniors, Boston-based Author Health launched at the end of June with a unique mission–reaching out to older adults with serious mental illness and substance use disorders–and with a tidy startup kitty. The company provides specialized physicians, nurses, therapists, and community health workers to deliver a mix of virtual and in-person care. Their first partnership is with Humana Medicare Advantage (MA) plans in Fort Lauderdale and Miami, Florida metros in conjunction with CenterWell Senior Primary Care. Author Health helps to treat conditions such as depression and anxiety, schizophrenia and psychosis, bipolar disorder, Alzheimer’s Disease and other dementias, and substance use disorders. Author is led by CEO Dr. Katherine Hobbs, a psychiatrist and former health insurance executive. The $115 million in initial financing was led by General Atlantic and included participation from Flare Capital Partners. Author Health release, FierceHealthcare, MedCityNews

TTA has previously profiled James Batchelor, CEO and founder of Alertacall. He is an old friend of TTA from early days with Editor Steve and Alertacall is one of the pioneering companies in UK telecare. Most recently (May 2022) Alertacall achieved the Queen’s Award For Enterprise: Innovation. This short interview with him in New Business UK discusses the importance of finding the right fit in long-term funding. If your buyers are in a sector with lengthy, complex sales cycles, it’s vital to find a backer that understands the selling space, which for Alertacall is ‘property management’. Even more important now!

Apparently in the wrong space is Headspace Health. The Los Angeles-based telemental health company is laying off 181 additional employees, or 15% of its current workforce. This follows on their December layoff of 5% or 50 employees. In the palmy days of mid-2021, Headspace acquired Ginger for a $3 billion valuation at that time [TTA 27 Aug 2021] to enter the enterprise market and acquired Sayana and Shine in 2022. It’s been a struggle ever since though they did not go the SPAC route, stayed private, and now claim 70 million members (actually downloads of their app), both individual and enterprise. Headspace expanded to the UK in January. Too much lookalike/soundalike competition and now a very hard road to that cliché, ‘a path to profitability’. LA Times, Mobihealthnews

Week-end roundup: more House actions on telehealth benefits, VA EHR; Oracle exec moves to FDA digital health; Angle Health raises $58M; layoffs at Akili, Innovaccer, Athenahealth, Mindstrong

February 4, 2023 | by

Has the House in this 118th Congress acquired a propensity for taking fast action? It seems that under the new Speaker, the House on both sides, though divided, is energized and responding to changes that would benefit worker health–and perhaps find a way out of the VA Tower of Trouble that would ultimately benefit veteran care.

The first is a short (four page) bipartisan bill still in draft, the Telehealth Benefit Expansion for Workers Act, that would amend current law in the Public Health Service Act, the Employee Retirement Income and Security Act of 1974, and the Internal Revenue Code of 1986 to allow employers to provide telehealth to employees as excepted benefits. This allows employers to finance an additional benefit not covered under their primary health plan. Examples of excepted benefits are vision and dental plans. Sponsors of the bill are Rep. Suzan DelBene (D-WA) as lead and co-sponsors  Tim Walberg (D-MI), Angie Craig (D-MN), Ron Estes (R-KS), Mikie Sherrill (D-NJ), and Rick Allen (R-GA). This builds upon the Medicare and other plan reimbursement expansions contained in the omnibus budget plan passed in the 117th Congress that extended telehealth in high-deductible health plans with health savings accounts (HSAs). At this point, the bill is not numbered, submitted, or on Congress.gov. HealthcareITNews

Not addressed in this bill or any other is whether the extensions will cover hospital-at-home remote patient monitoring (RPM) that was permitted under waivers during the Public Health Emergency (PHE). With its scheduled 11 May end, the Connected Health Initiative (CHI) believes that CMS will not allow remote monitoring to continue in hospital-at-home programs, under current reimbursement and devices. CHI had sent Congress at the end of January a list of their priorities and they’ve received a hearing, but no action has been taken yet. Healthcare Finance

The second is a House bill that would support solving the issues around the VA implementation of the Oracle Cerner EHR without returning to VistA. This is being proposed by Democrats on the House Veterans’ Affairs Committee. According to FedScoop, which broke the story, this is being worked on as an alternative to Rep. Matt Rosendale’s H.R. 608 which would pull the plug on Oracle Cerner and revert back to VistA [TTA 1 Feb]. Exactly how this bill would solve Oracle Health’s issues with Cerner Millenium and support VA in continuing that EHR implementation after June is not specified. FedScoop’s source told them that “the proposal may have a wider scope than prior attempts at legislative oversight and could involve a complete rethink of how other IT projects are conducted within the agency. This proposal is focused at a higher level than just one program.” The lack of specificity in this broad brush is not precisely reassuring, but a bipartisan ‘game on’ by both parties on Veterans Affairs, perhaps a ‘good cop/bad cop’ treatment, could be an effective ‘nowhere to hide’ approach with Oracle. Becker’s

Oracle’s loss, FDA’s gain. Troy Tazbaz, formerly Oracle’s senior VP heading up their cloud transformation efforts, joined FDA as Director of their Center of Digital Health Excellence. In that capacity, he will be in charge of technology evaluation, policy development and strategic partnerships for safe healthcare use of digital technologies that advance public health. Certainly he is tanned, rested, and ready: Mr. Tazbaz  left Oracle last September and used part of that time to achieve a dream of bicycling from Chesapeake Bay in Maryland to San Francisco Bay over 58 days. FierceHealthcare

Employer insurer Angle Health raised a $58 million Series A. Lead was Portage Ventures, along with PruVen Capital, Wing Venture Capital, SixThirty Ventures, Mighty Capital, and several others. Angle’s angle is to act as a fully digital, full-stack insurance carrier that delivers comprehensive healthcare benefits tailored to startups and technology companies on one platform. Their baseline telehealth offering covers primary care, urgent care and behavioral health, outsourced to Included Health. They bundle this with administrative services and care navigation, and use the First Health and Cigna PPO networks according to their website. Angle recently expanded from Utah into Arizona, Georgia, Indiana, Ohio, Missouri, and South Carolina. Release, FierceHealthcare

Unfortunately, layoffs continue in and out of healthcare as funding and usage go south:

  • Akili Interactive in January cut 30% of staff, or 46 people. Akili has developed cognitive therapies for ADHD and other mental illness, including EndeavorRx, a prescription treatment delivered through a video game. Non-ADHD therapies have been put on hold. They announced going public via a SPAC in January 2022 via a merger with Social Capital Suvretta Holdings Corp. I which closed last August at over $14, and are currently trading at $1.92. Mobihealthnews
  • Innovaccer, a health data analytics company, later in January laid off 15%, or 245 people, in the US and India, to concentrate on their ‘core portfolio’. This is their second layoff round;  90 people or 8% went in September. This was quite a turnaround to their sunny-side up 2021, where they raised Series D and E rounds totaling $255 million backed by Tiger Global, Whale Rock, Mubadala Group, and Microsoft M12, achieving a unicorn valuation over $3 billion.  Mobihealthnews, Inc42.com
  • Athenahealth yesterday released 178, or 3% of its staff, two months after going private. They pointed to overhiring, a sluggish recovery in doctor visits, and inflation. They plan to release or move to less expensive office space in their current cities of Watertown, MA and Austin, TX. Boston Globe
  • In yet another sign that virtual mental health’s boom is deflating sharply, Silicon Valley-based Mindstrong is essentially shutting down. Almost all of its C-suite including the CEO and CFO are gone plus an additional 128 jobs including therapists. It is closing its headquarters and is ceasing patient services as of 10 March, yet is still recruiting on its website. Employees are departing between 24 March and 15 April, when presumably the last one out the door will turn out the lights.  Mindstrong raised over $160 million since 2014 including a $100 million Series C in 2020. Behavioral Health Business

Healthcare cyberattack latest: NextGen EHR ransomwared by AlphV/BlackCat, back to normal – 93% of healthcare orgs had 1-5 ransomware incidents

January 25, 2023 | by

Cyberattacks on healthcare continue their drip-drip-drip. The latest is on an EHR/practice management platform used by small to enterprise-sized specialty practices, NextGen Healthcare. The hacker group associated with the AlphV/BlackCat ransomware moved into the system on 17 January. For a short time, they reportedly exhibited NextGen information on their extortion site but later took it down. NextGen reported a short-term disruption to operations. A NextGen spokesperson stated that “We immediately contained the threat, secured our network, and have returned to normal operations,” the spokesperson said. “Our forensic review is ongoing and, to date, we have not uncovered any evidence of access to or exfiltration of client data. The privacy and security of our client information is of the utmost importance to us.”  NextGen has also stated to this Editor that no patient data was affected.

NextGen is used by about 2,500 practices in the US, UK, India, and Canada, including over 20 specialties.

The group behind AlphV/BlackCat ransomware has an infamous history. Reputedly, the gang has been kicking around since 2012 and was the same group of charmers that attacked the Colonial Pipeline in 2021, using the Darkside ransomware in May 2021 that dried out gas stations across the US East Coast. Their next ransomware edition, BlackMatter, targeted agriculture during fall 2021. Healthcare IT News, The Record/Recorded Future News

More severe attacks affecting 93% of healthcare organizations. While NextGen contained the attack quickly, both the Censinet/Ponemon Institute and Fortified Health Security’s 2023 Horizon Report tracked 2022 healthcare data breaches and concluded that while the number of incidents didn’t change much, their severity ramped up. More according to SC Media in these reports: 

  • Over a dozen of the biggest incidents in 2022 each impacted well over 1 million records
  • Nearly half of the respondents experienced a ransomware attack in the last two years
  • 93% faced between one to five ransomware-related incidents
  • Outages lasted upwards of 35 days

The common ground with NextGen is danger to patient safety, because electronic record damage can translate quickly into unavailable patient care.

Updated PharmaCare Services, a pharmacy management company based in Texas, is listed as a victim on BlackCat’s extortion site. They were exhibited with NextGen and remained when NextGen’s listing was challenged and then taken down. PharmaCare is staying mum on any ransomware disruptions, according to GovInfoSecurity.

One ray of hope is improved medical device security, included in the ‘omnibus’ budget package approved in late 2022. FDA will be required to enforce new standards for premarket device submissions. One is a software bill of materials, adequate evidence to demonstrate the product can be updated and patched, and a description of security testing and controls. This was before Congress in the Protecting and Transforming Cyber Health Care (PATCH) Act which didn’t go far, but elements of which found their way into the omnibus. A needed change for medical devices and long expected by manufacturers. SC Media

Owlet gets back into the baby zzzzz’s market with Dream Sock and Dream Duo–but now not medical devices!

February 16, 2022 | by

Without a splash or fuss, Owlet reintroduced its baby monitoring sock as the Dream Sock last month. Formerly known as the Smart Sock, Owlet got into FDA Hot Water in October [TTA 4 Dec 21] with their marketing the Smart Sock, which monitored sleep patterns, blood oxygen saturation, and pulse rate, as a medical device that would fall under 510(k) marketing clearance requirements, including premarket approval (PMA). The Smart Sock and Smart Duo were pulled from market on 22 November.

The Dream Sock, according to Owlet’s product page, is all about baby sleep, measuring sleep quality indicators, including wakings, heart rate, and movement. It provides a sleep quality score via a sleep coaching app. The difference between the old sock and app is that the blood oxygen saturation (SpO2) measuring capability is deleted. The SpO2 monitoring and the claims they were making were likely causes of the FDA’s warning.

The web store listing is for $299 for a Dream Sock fitting up to 18 months, with the Dream Sock Plus, which fits 0-5 years, at $359. The Dream Duo adds the Cam video baby monitor to the system for babies up to 18 months for $399. Sales are restricted to the US at this time. The products can also be found on the usual web stores.

On both the home page and on the product pages, the disclaimer statement is loud and clear:

WARNING: Owlet products are not medical devices. They are not intended for use as medical devices or to replace medical devices. They do not and are not intended to diagnose, cure, treat, mitigate, alleviate or prevent any disease or health condition, or investigate, replace or modify anatomy or any physiological process. [snip]

Digging into the website, Owlet states that they are “actively pursuing submitting a medical device application to the FDA to bring the Smart Sock technology to medical and consumer markets in the future.”

Owlet shares (OWLT:NYSE) have taken a massive value drop since it completed its SPAC with Sandbridge Acquisition Corporation and parked in the Unicorn Lot last July. It opened at $8, crested to over $10 in mid-August, then started to drop precipitously before Labor Day. It closed on Tuesday at $1.83. If only for the Cute Factor, one wishes them luck.

Owlet sock pulled from US distribution after FDA warning letter

December 4, 2021 | by

Awwww turning to Owwwww! High-flying Owlet has lost some altitude due to the consequences of a 5 October FDA warning letter. The outcome, at least for now, is that Owlet cannot sell its Smart Sock in the US. The Smart Sock measures sleep patterns, blood oxygen saturation, and pulse rate through pulse oximetry. FDA is now considering it a medical device that falls under 510(k) marketing clearance requirements, including premarket approval (PMA). Effective 22 November, the Owlet app will no longer be downloadable, although current owners who have downloaded the app for the Smart Sock and the Cam will not be affected. There are Owlets in the reseller pipeline, such as Amazon, which have now been rendered non-working. The Owlet Smart Sock can be sold outside the US, but not from the website.

What is surprising from the FDA letter is that they have had this issue with Owlet for five years. From the letter: “Since 2016, the FDA has corresponded with Owlet that the Owlet Smart Sock meets the definition of a device under the FD&C Act and does not fall under the compliance policy for low-risk products that promote a healthy lifestyle (General Wellness guidance).” The latter is a catch-all that has enabled various tech products to go to market with statements such as “not intended to diagnose, cure, treat, alleviate or prevent any disease or health condition”. It may have been either an escalation of monitoring capabilities, of marketing, or of the FDA deciding after the SPAC that Owlet needed to be treated differently. Owlet came to market in 2013.

Owlet’s letter to customers alludes to the FDA warning letter and that no safety issues were raised. They promise here and on the website that they will “transition to a new app and consumer wellness product that addresses FDA’s concerns”. The website continues to sell the Owlet Cam and Dream Lab, with ‘Coming Soon’ in January for the new Dream Sock and Dream Duo, but with no details. What’s not known are any details on their capabilities, whether they will fall under ‘general wellness’, and whether Owlet has begun the laborious and long process of filing as (likely) a Class II device.

Owlet enjoyed a SPAC during the summer [TTA 23 July] that nabbed it $135 million and a valuation of over $1 billion. It traded then at $8. Today’s close was $3.95. Its market cap is now less than half. It’s disappointing to this Editor that Owlet didn’t file with FDA well before the SPAC. They now have the opportunity to get FDA clearance, but the more likely outcome is that, at least for now, they will market a less capable device that falls under ‘general wellness’. Deseret News, FierceBiotech, CNET, The Verge

Good news! Eight software functions no longer classified as medical devices under FDA.

April 21, 2021 | by

Good news for medical device designers. FDA is amending classification regulations as a result of changes made by the 21st Century Cures Act to the Federal Food, Drug, and Cosmetic Act (FD&C Act). These remove certain software functions from the definition of a device  “including software functions that are solely intended to transfer, store, convert formats, or display medical device data and results, including medical images or other clinical information.” The changes apply to software in the following devices and systems:

Calculator/Data Processing Module for Clinical Use
Continuous Glucose Monitor Secondary Display
Automated Indirect Immunofluorescence Microscope and Software-Assisted System
Medical Device Data Systems
Home Uterine Activity Monitor
Medical Image Storage Device
Medical Image Communications Device
Picture Archiving and Communications System (PACS)

Read more in the Federal Register. Hat tip to HISTalk Monday Morning Update

2021 predictions: telehealth law and if at all possible, stay away from FDA (US)

January 14, 2021 | by

crystal-ballFoley & Lardner rolls out five predictions for telehealth/digital health law and policy in the US:

1. Licensing: More Efforts to Increase Reciprocity and Reduce Barriers. During the current PHE, HHS and states waived many telehealth requirements, including HIPAA and licensing. As the PHE does not look to be ending anytime soon, look for this to continue and eventually be part of Federal policy as soon as the fall. The status quo in Medicare is rural telehealth only–and that restriction is being recognized as absurd. (Related TTA article on the 2021 Physician Fee Schedule [PFS])

2. Modalities: Technology-Neutral State Laws that Prioritize Quality of Care. States are all over the place with telehealth. Currently, changes have been through legislation with others by executive order or regulation. The American Telemedicine Association published a guide to standard practice and terminology language mid-last year (revised in September) to help guide state lawmakers. One can only hope they follow this recommendation from the ATA. 

3. Privacy: Greater Sensitivity to Patient-as-Consumer in Digital Health. Increased privacy regulations will run up against interoperability and data sharing. In this Editor’s view, this will continue to be a battleground, as in data sharing, there’s Gold In Them Thar Hills and Big Tech has its eye on it.

4. Enforcement: OIG/DOJ Will Build on Prior Investigations. This is the area of Medicare overpayment, wrong payment, and fraudulent tele- and TV marketing of medications, genetic testing, and DME. This massive takedown including opioids made headlines last year [TTA 2 Oct] and included $4.5 bn in fake telemedicine claims. It’s kind of a no-brainer that with the expansion of telehealth, this will continue. It’s always been on the Fed’s radar screen.

5. Payment: Continued Expansion of Telehealth Reimbursement. Again, a ‘Captain Obvious’ with the changes in the 2021 PFS plus resistant states like NY and Massachusetts finally on board with parity (ATA on NY and MA). There are some interesting adds that employers will increasingly pay for tele-primary care, behavioral health, and specialty care like fertility, which again is a no-brainer when your workforce is remote and you want to keep them online. Where telehealth needs a permanent boost is in Federal value-based care programs run by CMS, like shared savings and Primary Care First.

So you’re introducing a telehealth platform or device that you’d like to say ‘FDA-cleared’. This may not be the time to deal with FDA.  Bradley Merrill Thompson of Epstein Becker & Green, P.C., well known to be one of the leading lights in telehealth law and advocacy since Ur-Days, makes a very convincing case to avoid the FDA 510(k) process–if you can. 1) FDA is jammed. 2) it’s a long haul, nearly a year as of 2019, probably longer for 2020 and 3) if you are de novo without any predicate device, you have maybe a 50 percent chance of success.  His anecdotal take is that FDA clearance doesn’t lead to a boost in revenue. Mr. Thompson has also studied the fearsome Warning Letters, and the few for 2020 mostly involved exaggerated or unproven claims around COVID-19. None involved unapproved claims for a digital health product. 

In this Editor’s view, customers won’t be hung up on an FDA clearance if you do what you say you’re going to do at the price they want to pay. Investors need to know this. Some markets do require FDA clearance, however. This Editor experienced this working for her first digital health company, Living Independently Group, where GE Healthcare before acquiring insisted that we take the system through an unnecessary Class I (!) approval. In dealing with vital signs monitoring and Federal purchasing, our Class II filing at Viterion was required. His advice is to watch your claims and work on your business model. Much, much more from Mr. Thompson in Mobihealthnews.

The Theranos Story, ch. 61: Elizabeth Holmes as legal deadbeat

October 9, 2019 | by

Did her lawyers expect otherwise? This weekend’s news of Elizabeth Holmes’ legal team at Cooley LLP withdrawing their representation services due to non-payment should not have caused much surprise. Cooley’s attorney team petitioned the court to withdraw from the case, stating that “Ms. Holmes has not paid Cooley for any of its work as her counsel of record in this action for more than a year.”

Cooley was representing Ms. Holmes in a class-action civil suit in Phoenix brought against her, former Theranos president Sunny Balwani, and Walgreens, charging fraud and medical battery. (When they withdraw, will she seek public representation based on poverty?)

Perhaps Ms. Holmes is the one who’s setting priorities, as the civil suit would be for monetary damages, and no money means there will be none for the plaintiffs to collect. The DOJ charges are a different story. She is on the hook for nine counts of wire fraud and two counts of conspiracy related to her actions at Theranos. Conviction on these could send her to Club Fed for 20 years plus a fine of $250,000 plus restitution for each charge. [TTA 16 June]. 

Last Wednesday, both Ms. Holmes and lawyers for her and Mr. Balwani were in Federal court in San Jose on the wire fraud and conspiracy charges, demanding that the government release documents from the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that allegedly would clear them. After an hour, Judge Davila set 4 November as the next hearing date. 

Defending oneself does not come cheap, but after your company’s value crashes to $0 from $9bn, one might be looking for change in your Roche-Bobois couch and wondering if your little black Silicon Valley-entrepreneur formal pantsuit/white shirt ensembles will last through the trial. CNBC 2 Oct, CNBC 4 Oct, Fox Business, Business Insider

Events coming up soon–and in the autumn: Hunter College 13 May, Aging 2.0 London 21 May; NYeC’s November Gala, Connected Health Summit (16-18 Oct) poster call

May 7, 2019 | by

Health Tech and the FDA: What You Need To Know, Monday 13 May, from 5-7pm is a discussion on what you need to know if your health or medtech service or device needs FDA approval. The main presentation is by Rebecca Wood, Partner at Sidley Austin LLP and former Food and Drug Administration Chief Counsel, and moderated by Charles Platkin, PhD, JD, MPH, the co-executive director of the Hunter College Center for Health Technology. Tickets are free but registration is required here (Eventbrite). Location is Hunter College, 2180 Third Avenue @ 119th Street, Main Auditorium (on 2nd Floor), NYC. Hat tip to Sonia K. Gonzalez in the Health 2.0 NYC Community.

And in London 21 May, conveniently the evening before the Digital Health and Care Congress, warm up at Aging 2.0 London to learn how age-tech “Zebras” (Z) a/k/a businesses, can take advantage of age-tech advances and hear from a panel of five from start ups, investors and government on the opportunities, challenges and realities of the UK tech business. Hurry–the website indicates only 25 tickets left. London, 21 May, 5.30 pm at Google for Startups London Campus, 4-5 Bonhill Street London.

Save the date, and plan ahead! The New York eHealth Collaborative, a regional non-profit organization that promotes the integration of health information through exchanges (HIEs), hosts an annual Gala that is one of the major events on the local New York healthcare business calendar. This year, the Gala will be the evening of 20 November at the Edison Ballroom in Manhattan. Your Editor attended in 2017 (missed 2018) and it was a memorable event. It annually honors three to four national healthcare executives who are also leaders in healthcare technology. If you are at all engaged with healthcare systems and technology in the New York metro area, it’s worth your time and fisc to attend this event to be the company of over 250 C-suite executives, leaders, and policymakers. Gala and Awards website  

Your Editor still misses their conferences, the last of which was one of the best she ever attended in (unbelievably) 2016 [TTA 17 Jan 17]. In 2014, their conference was also the site of an epic Eric Topol/Ezekiel Emanuel ‘face-off’ of radically diverging visions. That was hard to top! Their Executive Director Valerie Gray shares NYeC updates on YouTube including updates on Federal health tech initatives: TEFCA enabling nationwide health information exchange, and two similar proposed rules from CMS and ONC on interoperability, both with comment periods ending in June. 

Call for Poster Abstracts starts 27 May for the Connected Health Conference in Boston 16-18 October. Now a joint presentation of PCHAlliance and Partners HealthCare, the Call for Abstracts for Posters starts on 27 May and ends 27 June. The 2019 theme is Designing for Healthy Habits and Better Outcomes. For more information and application, see here. Winners receive a complimentary registration to the conference for the presenting author and discounted tickets for co-authors. TTA has been a past media sponsor of both the Connected Health Conference and NYeC’s Digital Health Conference.

The Theranos Story, ch. 59: there’s life left in the corporate corpse–patents! And no trial date in sight.

April 25, 2019 | by

You can get blood out of this. Really! The US Patent and Trademark Office (USPTO) awarded five–count ’em, five!–patents to Theranos in March and April. All of them were filed between 2015 and 2016, when the whispers of fraud were getting louder, as were the legal threats.

The five patents are:

1. Systems, devices, and methods for bodily fluid sample collection, transport, and handling
2. Systems, devices, and methods for bodily fluid sample transport
3. Systems and methods for sample preparation using sonication
4. Systems and methods for sample preparation using sonication (cell disruption)
5. Rapid measurement of formed blood component sedimentation rate from small sample volumes

The CB Insights Research article has the details on what they cover, including patent application illustrations. It’s not stated, but looking back to TTA’s many articles, in this Editor’s judgment, the heir to these patents cannot be Elizabeth Holmes or her many investors now feeling the lint in their pockets, but the company holding the last note, the $65 million (not $100 million) loan from Fortress Investment Group LLC, part of Japan’s SoftBank Group [TTA 28 Dec 17]–collateralized by the portfolio of over 70 patents. Hat tip to HISTalk 19 April

If you hunger for a deep dive into the design of Theranos’ blood analyzers that never really worked, and can appreciate that the miniLab was what “one expert in laboratory medicine called “theater … not science”, this Design World article is for you: Schadenfreude for Theranos — and satisfaction in how engineering doesn’t lie

Meanwhile, back in the US District Court in San Jose, California, we learn that the trial of Ms. Holmes (now engaged to William “Billy” Evans, a 27-year-old heir to the Evans Hotel Group, which has three West Coast resort properties and who is also a techie) and former Theranos president Ramesh ‘Sunny’ Balwani has been delayed indefinitely. Originally reported to be summer entertainment with a start date of 8 July, the judge set the next status conference for the case for 1 July, but refused to set a trial date, which means that the trial may not begin till next year. According to the San Jose Mercury News, the defense is seeking materials from the FDA and CMS, which are, according to defense lawyer, lawyer Kevin Downey, are “in many instances exculpatory.”

Ms. Holmes’ lawyers are also seeking information on the communications between John Carreyrou of the Wall Street Journal, the FDA, and CMS. In a motion filed last week, they accused Mr. Carreyrou under the guise of investigative journalism of “exerting influence on the regulatory process in a way that appears to have warped the agencies’ focus on the company and possibly biased the agencies’ findings against it.” Stat

The bubbly Ms. Holmes and Not-So-Sunny Balwani are facing Federal charges of two counts of conspiracy to commit wire fraud and nine counts of wire fraud. They each face a maximum of 20 years in prison and up to $2.7 million in fines.

A selection of short digital health items of potential interest

February 8, 2019 | by

Editor Charles has taken time off recently from assessing mHealth apps to give us a selection of short news items and event notifications.

CE and FDA certification

This editor recently stumbled over the first list he’s ever seen of approved digital health medical devices. As of today there are some 151 products on there which is hugely impressive. One of the reasons for the relatively poor showing of CE certifications on the list is that there is no official list yet: latest forecasts for Eudamed, which will provide this, are Spring 2020 amid much uncertainty about whether enough Notified Bodies will be approved to certify to the MDR in time. Immediately spotted as a CE certification missing is Walk with Path’s Path Finder device for helping people with Parkinson’s to avoid a freezing of their gait (though CE certification is well hidden on their website) and doubtless there are others. Clearly the list points up potential benefits were it ever possible to harmonise the approval process across the Pond.

Longevity 

The first Longevity Leaders event took place on Monday, perhaps the first large event in the UK on that topic. Based on the enthusiasm of attendees, clearly it won’t be the last. Doubtless in due course it will fragment into a myriad of specialist topics though currently it is a fascinating combination of almost every medical/pharmaceutical and digital discipline, plus housing and a range of other considerations. Timescales varied widely too – for example I talked about the immediate benefits of digital health including keeping people in their own homes, thus minimising sarcopenia from being confined to a hospital bed and avoiding exacerbating dementia by a change of environment, whereas others spoke of how best to make DNA immortal and whether the first person destined to live to 1000 had already been born.

Clinical  Homecare

From the sublime (last item) to the The National Clinical Homecare Association‘s conference on 31st January, where this Editor also spoke on how digital health could help people to be treated in their own homes. Notable was the absence of any Twitter handle for the Association, no hashtag for the conference and just two people it seemed out of 250 using social media. Clearly there are huge opportunities here for digital health suppliers, particularly as so much of what was said by other speakers, and what was being shown in the exhibition was very much manually-intensive stuff: join the NCHA and start a revolution in clinical homecare! 

Recent developments in AI

Since this editor stopped active involvement in conference organisation for the Royal Society of Medicine it is encouraging to see that the younger generation has picked up the baton and is running even harder, such that the above event, on 26th February, has proved so popular that it has been moved to the largest (300 seater) lecture theatre at the Society, and on current sign-up rate will sell out.  Speakers from Babylon, Ada Health, DeepMind, Kheiron Medical, BenevolentAI, UCL Life Sciences & Alan Turing AI partnership, and many more will ensure that delegates gain a comprehensive understanding of how AI is being used across healthcare. Book here to experience the delights of the new RSM all-new website which makes signing up for an event so much easier than in the past. Fear not though: the RSM’s legendary low ticket costs are maintained!

Wayra and Novartis

A most exciting event this week was the announcement of the joint Wayra and Novartis health call now looking for their next cohort of remarkable start-ups to join their new programme called The Health Hub. This is built together with their new partner Novartis, one of the leading pharma companies. Their focus is on how healthtech can be used drastically to innovate long-term disease management. Apply here, by February 17th. Hat tip to Professor Mike Short for this item and other observations in this post .

Rewired Pitchfest

Early health tech entrepreneurs should consider taking part in the Rewired Pitchfest at the Digital Health Rewired Conference and Exhibition, Olympia London on 26 March. Sponsored by Silver Buck, this provides the opportunity for early stage digital health start-ups to showcase their disruptive ideas and prototypes to NHS IT leaders. Applicants will compete before a judging panel featuring investors and successful start-up founders. It’s a great way to gain significant exposure and make connections with a diverse range of UK digital health leaders…and the winner will be announced, and congratulated, by Matt Hancock himself! There is also the chance of winning a mentoring programme with the experts on the judging panel and PR features in Digital Health News. (Disclosure: this editor is on the Programme Committee of Rewired, as well as being a Pitch judge)

Punning headlines

It’s rare that a single item is worthy of its own paragraph on TTA these days however an exception must surely be made for one of the few punning headlines to be found in digital health, especially as it’s for such an old – and until now undelivered – idea: “Smart toilet seat is flush with possibilities to monitor patients’ health”

The Theranos Story, ch. 52: How Elizabeth Holmes became ‘healthcare’s most reviled’–HISTalk’s review of ‘Bad Blood’

July 5, 2018 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2018/07/holmes-barbie-doll-1.jpg” thumb_width=”125″ /]A Must Read, even if you don’t have time for the book. During the brief Independence Day holiday, this Editor caught up with HISTalk’s review of John Carreyrou’s ‘Bad Blood’, his evisceration of the Fraud That Was Theranos and The Utter Fraud That Is Elizabeth Holmes. Even if you’ve read the book, it’s both a lively recounting of how the scam developed and the willingness–nay, eagerness!–of supposedly savvy people and companies to be duped. The reviewer also reveals that Mr. Carreyrou wasn’t the first to raise questions about Theranos after raves in the press and kudos from the prestigious likes of Eric Topol. Mr. Carreyrou’s first article was in October 2015 [TTA 16 Oct 15] whereas Kevin Loria wrote the first exposé in Business Insider on 25 April 15 which raised all the fundamental questions which Theranos spun, hyped, or otherwise ignored–and Mr. Carreyrou eventually answered. (Our blow by blow, from him and other sources, is here.)

The review also picks out from the book the scabrous bits of Ms. Holmes’ delusions; her makeover to become the blond Aryan female Steve Jobs mit Margaret Keane-ish waif eyes–something she took far too literally; the affair between her and Sunny Balwani, certainly in violation of the usual ethics–and her Hitler in the Bunker, April ’45 behavior as Theranos collapsed around her. 

The review concludes by telling the healthcare community something we need said plainly, often, and written in 50-foot letters:

Theranos is a good reminder to healthcare dabblers. Your customer is the patient, not your investors or partners. You can’t just throw product at the wall and see what sticks when your technology is used to diagnose, treat, or manage disease. Your inevitable mistakes could kill someone. Your startup hubris isn’t welcome here and it will be recalled with great glee when you slink away with tail between legs. Have your self-proclaimed innovation and disruption reviewed by someone who knows what they’re talking about before trotting out your hockey-stick growth chart. And investors, company board members, and government officials, you might be the only thing standing between a patient in need and glitzy, profitable technology that might kill them even as a high-powered founder and an army of lawyers try to make you look the other way.

In other words, what you (the innovator, the investor) is holding is not a patient’s watch, it could be his heart, lungs, or pancreas. (Musical interlude: ‘Be Careful, It’s My Heart’)

The Theranos Effect is real in terms of investment in small companies out there on the ‘bleeding edge’. The cooling is mostly salutory, and we’ve been seeing it since late last year (see here). But…will we remember after it wears off, after the fines are collected, the prison time is served?

The Theranos Story, ch. 46: “F for Fake.” SEC’s fraud charges force Elizabeth Holmes out (finally).

March 15, 2018 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]Our New Year’s 2018 prediction (after December’s $100 million loan from Fortress Investment Group): “Ms. Holmes will be removed and replaced, then the company will be reorganized and/or renamed.”

Fortress did not have to wait long or get their hands dirty. Today, the Securities and Exchange Commission (SEC) charged both founder and now former CEO Elizabeth Holmes and past CEO/president Ramesh ‘Sunny’ Balwani with securities fraud. While Mr. Balwani will fight the charges, Ms. Holmes escaped trading her black turtleneck for an orange jumpsuit by agreeing to pay a penalty of $500,000 to the SEC, give back 18.9 million shares to the company, give up her uniquely Silicon Valley perk of super-voting equity rights, and is now barred from serving as a public company director or officer for 10 years. From the Theranos release: “As part of the settlement, neither the Company nor Ms. Holmes admitted or denied any wrongdoing.”

This penalty may seem puny in the light of other securities fraud cases, but it appears that Ms. Holmes took little salary out of the company, with most of her long-gone billions in presently worthless remaining stock. 

The exact meaning of fraud, as determined by the SEC in cases like these, is not casual. We can say that we never believed the Edison or miniLabs would work despite the press hype. We can observe that patients and doctors were misled in test results, resulting in major human cost (our Ch. 22).  The fraud here is directly tied to representations made to investors that enabled Theranos’ massive funding, in multiple rounds, of over $700 million between 2013 to 2015. These misleading representations included demonstrations, reports on the functioning of its analyzers, inflating its relationships such as with the DOD, and its regulatory status with the FDA.

It also does not matter that all the funds were privately raised. The SEC in its statement firmly stated that it will treat private equity as it does public when it comes to investments (pay attention, health tech companies): (more…)

Breaking: FDA approves the first drug with a digital ingestion tracking system

November 14, 2017 | by | 1 Comment

Not many drug approvals warrant an FDA press release, but this one did and deservedly so. The US Food and Drug Administration (FDA) approved a version of the psychiatric drug Abilify (aripiprazole) equipped with the Proteus Digital Health ingestible tracking system. Abilify MyCite has been approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. It is the first approved commercial version of a drug equipped with the Proteus Discover system, which tracks the ingestion of the pill from a sensor in the tablet activated by gastric juices to a patch worn by the patient and then to a smartphone app. The patient, caregivers, and physicians can track medication usage (timing and compliance) through the app, adjusting dosage and timing as needed.

The Proteus press release states that the rollout is gradual through select health plans and providers, targeting a limited number of appropriate adults with schizophrenia, bipolar I disorder, or major depressive disorder. It is contra-indicated for pediatric patients and adults with dementia-related psychosis.

Abilify, developed by Japan’s Otsuka and originally marketed in the US with Bristol-Myers Squibb (BMS), has been generic since 2015. This Editor finds it interesting that Proteus would be combined with a now off-patent drug, creating a new one in limited release. Proteus’ original and ongoing tests were centered on combining their system with high-value (=expensive) drugs with high sensitivity as to dosage times and compliance–for instance, cardiovascular and infectious disease (hepatitis C, TB). Here we have a focus on managing serious mental illness and treatment. 

Editors (Steve and Donna) first noticed Proteus as far back as September 2009. Looking back at our early articles, Proteus has come a long way from ‘creepy’ and ‘tattletale’. With nearly half a billion dollars invested and a dozen funding rounds since 2001 (Crunchbase), approvals were long in coming–nine years from submission of patch and tablet sensor to the FDA (2008), seven years from the patch approval (2010), five years from the tablet sensor approval (2012), to release of a drug using the Proteus system. The only thing this Editor still wonders about is what happens to the sensors in the digestive tract. They contain copper, magnesium, and silicon–copper especially can be toxic. If the sensors do not dissolve completely, can this be hazardous for those with Crohn’s, colitis, or diverticulitis/diverticulosis?  Hat tip to Bertalan Meskó, MD, PhD, via Rob Dhoble, on LinkedIn.

Also, if you can stand it, a lengthy article from the New York Times with lots of back and forth about the existential threats of monitoring drugs, potential coercion (preferable to injected Abilify), how some with schizophrenia already manage, and Proteus as a ‘biomedical Big Brother’. (Some commenters appear to have the very vapors about any digital trackers, including AiCure and etectRx.)