News roundup: DDoS attacks may be ‘smokescreen’, DEA slams Truepill with ‘show cause’, telehealth claims stabilize at 5.4%, Epic squashes patent troll, Cerner meeting exits KC, MedOrbis, Kahun partner on AI intake

Readers won’t get out of 2022 without one last cybercrime…article. DDoS attacks–distributed denial of service–escalated worldwide with Russia’s invasion of Ukraine in February. (Ukraine and military aid is a hot topic this week with President Zelenskyy’s visit to the US and Congress speech.) Xavier Bellekens, CEO of Lupovis, a cybersecurity company and a cyberpsychologist (!), postulates that DDoS attacks, as nasty as they are, may be a smokescreen for far more nefarious and damaging attacks. While IT goes into crisis mode over the DDoS, other attacks and information gathering on systems preparing for future attacks are taking place. Russian cyber groups focus on large organizations and move down the line into the most vulnerable, using both manual and automated approaches. Worth reading given the vulnerability and IT short staffing in healthcare organizations. Cybernews

The fallout from Cerebral and Schedule 2 telehealth misprescribing expands. The Drug Enforcement Agency (DEA) issued a ‘Show Cause’ to online pharmacy Truepill for inappropriate filling of ADHD Schedule 2 medications, including Adderall. A ‘Show Cause’ order is an administrative action to determine whether a DEA Certificate of Registration should be revoked, which could put Truepill out of business. The red flag for the DEA: 60% of  Truepill’s prescriptions–72,000–filled between September 2020 and September 2022 were for controlled substances, including generic Adderall. Truepill was Cerebral’s primary mail order provider, though they also used CVS and Walmart. The company stopped filling Cerebral’s ADHD prescriptions in May 2022.

In the order, the DEA cites that “Truepill dispensed controlled substances pursuant to prescriptions that were not issued for a legitimate medical purpose in the usual course of professional practice. An investigation into Truepill’s operations revealed that the pharmacy filled prescriptions that were: unlawful by exceeding the 90-day supply limits; and/or written by prescribers who did not possess the proper state licensing.”

The company stated in an emailed statement that they were fully cooperating with the investigation. If it does move to a hearing, Truepill’s chances of a successful defense are statistically low.

Truepill also fills prescriptions for Hims & Hers, GoodRx and Mark Cuban Cost Plus Drug Company. It was valued in its 2021 funding round at $1.6 billion. Companies in telemental health and prescribing of Schedule 2 ADHD medications, such as Cerebral and Done Health, are under enhanced scrutiny over their business practices [TTA 1 June]. Mobihealthnews, DEA press release, HISTalk, Digital Health Business & Technology

Telehealth medical claims stabilize. FAIR Health’s latest reports for August and September report that the percent of medical claims coded as telehealth are back up to 5.4%. June and July dropped slightly to 5.2% and 5.3% respectively. Also steady are that the vast majority of claims are for mental health services. In September, they were 66% of diagnoses far ahead of ‘acute respiratory diseases and infections’ at 3.1%. In procedure codes, psychotherapy accounts for over 43%.

A patent troll Epically bites the dust. Back in the early to mid-2010s [TTA’s index here], patent trolls (technically non-practicing entities which have no active business) presented a significant threat to early and growth-stage health tech companies. One, MMR Global (which apparently no longer exists), was notorious for buying up EHR and PHR-related patents and then filing patent infringement lawsuits against both small and large healthcare organizations with similar patents–and their users–that were generally monetarily settled. But NPEs are still active. One in south Florida, Decapolis Systems, used the same techniques as MMR Global had, suing in this case multiple Epic customers for patent infringement. Epic not only defended its customers but also sued Decapolis in the US District Court, Southern District of Florida. The court found that both Decapolis patents were invalid, ending what Epic termed ‘vexatious patent litigation’. Decapolis had successfully sued 24 other entities, including other EHRs, which settled. Owned by an inventor, this company will have to find another line of honest business. Epic release, Thomson Coburg

Oracle’s message to Kansas City: no more Cerner meetings for you. And maybe more. Cerner’s site for its annual customer/partner conference since 2007 has been in Kansas City, attracting about 14,000 visitors. Not only will it be integrated into Oracle CloudWorld in Las Vegas, 18-21 September, it’s been retitled Oracle Health with no mention of Cerner. The loss to local KC business is substantial–estimated to be in the $18 million range. While it’s logical to integrate it into the massive CloudWorld conference, it’s also another message to KC after Oracle’s sudden real estate downsizing that Cerner’s presence there will shrink…and shrink..as it’s absorbed into Oracle Health, and further confirmation that the Cerner name is gradually being sunsetted. KansasCity.com, HISTalk

A new (to this Editor) specialty care telehealth company, MediOrbis, is partnering with Kahun for an AI-enabled digital intake tool. This is a chatbot capable of conducting an initial medical assessment. Based on the patient’s answers and Kahun’s database of about 30 million evidence-based medical knowledge insights, it provides a summary for the physician before the telehealth visit and highlights areas of concern. Mobihealthnews  MediOrbis also has partnered with remote care/engagement Independa to add its capabilities to Independa’s HealthHub on their LG TVs.

A mélange of short subjects for Tuesday

ATA accredits American Well, Apple ResearchKit, diabetic contact lenses, Hackermania Falls on Indiana, patent trolls get a haircut, and more

The ATA (American Telemedicine Association) has gained more than 200 applications for their US-only Accreditation Program for Online Patient Consultations [TTA 17 Dec 14]. First past the post in accreditation is American Well’s Amwell virtual visit app, which will shortly be listed on the ATA consumer website SafeOnlineHealth.orgRelease, MedCityNews….Stanford University, one of the five academic centers using the Apple ResearchKit, had a mind-boggling 11,000 signups for a heart health study–in 24 hours. The downside is that they may not be representative of the whole population [TTA 10 Mar, see 11 Mar update] including us Android users. 9to5Mac….The Google-Novartis glucose-measuring contact lens [TTA 17 July 14] for diabetes management just gained some Canadian competition–Medella Health in Kitchener, Ontario, founded by a team of (more…)

Finally a curb on ‘patent trolls’? (US)

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/09/TROLLS-1992-008.jpg” thumb_width=”150″ /] Those nasty patent trolls–those (largely) non-practicing entities (NPEs) which buy up patents to license them. Yet most of their revenue stream comes from pouncing on startup and early-stage companies to challenge their patents and systems, extracting la mordida to avoid further legal action. Now the Federal Trade Commission (FTC) has moved to curb one egregious practice: deceptive demand letters. The FTC issued an order to MPHJ Technology Investments LLC (MPHJ) banning its allegedly deceptive letters to companies which MPHJ considered to be infringing on its scanning technology. MPHJ filed first a draft complaint, and now a legal action against the FTC in the US District Court for the Western District of Texas, alleging violations of the First Amendment on free speech. Under US law, ‘deceptive’ may not be good enough–their letters threatening lawsuits must be shown to be ‘objectively baseless.’ The FTC requested dismissal of MPHJ’s suit this past Monday. Their rejoinder: the suit would disrupt its work.  National Law Review, Law360 (subscription/Lexis Nexis access required).

Previously in TTA on patent troll strategies and how companies defend themselves:  TTA 13 Sep 13, 10 Feb 13. (Also search on ‘patent troll’, ‘MMRGlobal’ and ‘patent infringement’.

Telehealth & IP Soapbox: Hacking through Patent Thickets

Not only do company founders have to deal with patent trolls, but find their way through patent thickets. Patent thickets are overlapping patent rights through which developers must find a safe, defensible space for their technology. This article introduces this concept to our readers and outlines a strategy to deal with it–in early days, and not sticking one’s head in the sand as this Editor has encountered. What may surprise you in reading this excellent article is that the author, Dolly J. Krishnaswamyis not an experienced litigator, but a law student at NYU while working as a Project Manager/Law Clerk, Goldstein Patent Law. She blends law, science, tech and journalism with her prior experience as a journalist for Science magazine, technology work in New York City and in the study of genetics while at Emory University. Enjoy the article.

Many of you are privy to the problem of excessive patents. You have all seen the articles about yet another cellphone company infringing on yet another patent, but what you’re left with are questions of what all this activity means and how to use that information to act in your best interest– whether you are the CEO of a company or the general counsel for one. At the 2013 ABA Annual Meeting held in San Francisco, legal experts tackled this problem, discussing the trends in patent litigation and some potential strategies for companies preparing to introduce products into heavily-patented market segments.

Generally speaking the use of patents can vary with some people using them for insurance and others using them strategically. From a business standpoint, how a company uses a patent depends on the industry that company is in. For example, in the medical technologies space, all the companies will have patents on their core technologies and be highly cognizant of the patents they have to deal with. With the record number of high patent filings, the continued state of high damages, and the fact that even smaller companies are beginning to see patent infringement lawsuits, it’s clear that patent strategy is a complex matter– further complicated by the presence of patent thickets. (more…)

How startups are being damaged by patent trolls–and turning the tables

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/09/TROLLS-1992-008.jpg” thumb_width=”150″ /]In February and for a few months, this Editor was on a tear about the quaintly dubbed patent trolls–primarily (but not always) non-practicing entities (NPEs) which don’t create or market products, but buy up other people’s/companies’ patents and then seek out opportunities to license them. These NPEs target and challenge vulnerable startups and early-stage companies to defend their patents and systems; the suit for royalties, the financial threat, the papers filed, the attorneys called, the money spent and the eventual settlement (or licensing) is in reality just a form of what’s called in Latin America la mordida. It becomes cheaper to settle than to fight–and the cost can be six or seven figures. 

The shots over the bow were in 2012: Bosch’s February lawsuits against Waldo Health, ExpressMD/Authentidate and MedApps (now Alere Connect) [TTA 16 Feb 2012] and then the strange practice of PHR developer/patent accumulator MMRGlobal [TTA 23 Oct 2012] in sending hundreds, perhaps thousands, of letters out to EHR/EMR users to advise them of possible patent violations and demanding licensing. This Editor observed then and during the spring this year that it was only a matter of time that NPEs would pounce on healthcare tech as investment action accelerated. Yet discussions by this Editor with companies in some public venues indicated a certain level of obliviousness to the threat–that there were not enough assets to go after, thus healthcare startups made poor targets–though side conversations with IP specialist attorneys indicated otherwise.

Well, the trolls have reared their fuzzy heads again, uglier than ever, in this drama-laced article in Wired. (more…)

MMR Global vs. Nehta, Round 2 (US/AU)

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/03/saved-by-the-bell1.jpg” thumb_width=”125″ /]Ding! The Australian reported last week that Nehta (National E-Health Transition Authority) is defending itself against charges by PHR company MMRGlobal that it has not responded to information earlier requested from and supplied by its operating company MyMedicalRecords and its licensee in Australia. MMRG is claiming that Nehta’s planned national PHR system will infringe upon patents held in Australia. According to The Australian article, Nehta’s chief Peter Fleming said that they learned of the claims only on 7 February and that MMRG had “nothing solid” to back them up:  “MMRGlobal has never contacted us at all and indeed our understanding is that they’re investigating a potential claim but have nothing solid” and “we’ve obviously taken a look at their patents, both from an architectural and a legal perspective, and have obviously briefed our lawyers to investigate, but certainly this company has not contacted us at all … We undertook very detailed analysis through third parties who put the standards in place around the world.”  The Australian (access via MMRGlobal website) Robert Lorsch, MMRGlobal CEO, has of course put on a full court PR press to counter this involving Australian singer Guy Sebastian and what appears to be a global awareness program to underscore the importance of a PHR–and their patents/IP–with Australian revenues being directed to a charitable foundation including charities Mr. Sebastian already supports. Guy Sebastian Speaks Out About MMRGlobal Patent Investigation in Australia (MarketWire via NBCNews.com) TTA recent related on MMRG: pre-HIMSS (26 Feb) and lawsuit update (20 Feb).

Telehealth Soapbox: Protecting your IP and patents online

This is the second of an occasional series on US law and intellectual property (IP) as it affects software and systems used in health technology. This article is an overview of the issues surrounding and actions you should take to protect your proprietary website, software and patents. Especially for early stage companies, the last has grown in importance with ‘patent trolls’ demanding settlement fees for claimed infringement.

Mark Grossman, JD, has nearly 30 years of experience in business law and began focusing his practice on technology over 20 years ago. He is an attorney with Tannenbaum Helpern Syracuse & Hirschtritt in New York City and has for ten years been listed in Best Lawyers in America. Mr. Grossman has been Special Counsel for the X-Prize Foundation and SME (subject matter expert) for Florida’s Internet Task Force. More information on Mr. Grossman here.

Imagine if you found a portion of your proprietary software or your website in cyberspace. The only problem was that it wasn’t located at your Internet address. Let’s say that it was smack in the middle of someone else’s website and/or made available for download. You would fume and want justice.

No License to Steal
The Internet, like many technologies, promises substantial consumer benefits and, at the same time, invites fraud and deception. The technology is such that it’s all too easy to steal software or a whole website with a mere click.
For businesses and consumers to continue to fuel the growth of the Internet we must aggressively address the protection of intellectual property (IP) rights online. Any good business plan maps out a strategy to maximize opportunity and to handle calculated risk. So protecting your IP rights must be a core part of your business plan.
You should consider taking the following steps to minimize your company’s risks. (more…)

PHRs, ‘meaningful use’ and patent infringement (US)

MMRGlobal CEO Robert Lorsch’s interview by HIStalk today is a fascinating follow-up to our recent stories in several areas. First is the story of how he came to found MMRGlobal, and how this personal health record (PHR) stores both electronic ‘hard copy’ and user-entered health history data which is generally accessible. It is a little different than Microsoft Health Vault or the late and unlamented Google Health, with access based on a 10-digit telephone number ‘lifeline’ and a subscription model. MMRG claims 750,000 members to date. While MMRG’s legal track record has raised quite a few health tech industry eyebrows almost to the hairline, your Editor has to admit their actions are quite different from your usual non-operating ‘patent troll’ which preys on vulnerable early-stage companies [TA 10 Feb].  MMRG’s big legal actions are to hook ‘big tunas’–Walgreens, WebMD–plus ‘investigations’ of the Australian and Singapore Governments, based on its seven US and international patents building up in their portfolio since 2005. They have also announced similar scrutiny of Microsoft and AARP for their projected joint PHR. [TA 10 Feb, 20 Feb]

But…there’s more. Mr. Lorsch proceeds to draw the proverbial line in the sand for hospitals and practices which intend to achieve Stage 2 Meaningful Use (MU) compliant EHRs this year into 2014. Stage 2 MU has at least five core measures that depend upon patient access, one of which requires a patient-facing portal that permits viewing, downloading and transmitting their own health information.  (Useful bite-sized explanation by Dr. Rowley at HITECH Answers.) MMRGlobal is taking the stance that they believe that any of these portals which store information, or are full PHRs, infringe on their patent portfolio:

If somebody complies with that Stage 2 Meaningful Use, we believe that they will infringe on one of seven patents that we have issued in the US Patent Office an additional patents that we have issued in 12 additional countries around the world. What we have done is we’ve gone to the hospitals, providers, vendors, laboratories, and we’ve said, “Look, if you’re going to comply with Stage 2 Meaningful Use or you’re going to offer products and services that enable healthcare professionals to meet Stage 2 Meaningful Use, they’re probably going to infringe on one of our patents.”

We’re suggesting that they license those patents at very reasonable license fees, such that whatever they decide to do to comply with Stage 2, Stage 3 Meaningful Use, they have a license – a safe harbor — that they’re grandfathered in, where they never have to be concerned about infringement on any of our patents or other intellectual property. If those same hospitals say, “Are there any other ways to address this?” they could also use our products — our MyMedicalRecords products, our professional products — which are embedded with licenses for the technology.

The interview then proceeds to the money points: how hospitals, especially non-profits, and associations can ‘reasonably’ (again) pay to MMRG (or negotiate on behalf of members) those licensing fees, or simply buy the MMRG PHR.

Which leaves this Editor with a question: these systems are supplied by major companies: Cerner, Epic, McKesson, GE. The hospitals and large practices are only system users, albeit with considerable user HIT customization. If the PHR is part of the Epic, Cerner (etc.) system, and the hospital buys the system, isn’t the true source of the patent infringement the supplier, not the end user? Or is this MMRGlobal’s strategy to avoid being a snack for some very large and aggressive sharks? It remains….fascinating. HIStalk Interviews Robert Lorsch, CEO, MMRGlobal  Hat tip to reader Vince Kuraitis via Twitter.  Also to be noted are the on-fire comments under the article which clarify many of the US patent issues, and possible defense strategies which hospitals and associations/groups may follow.

Update 28 Feb: The latest MMRGlobal pre-HIMSS press release announces ‘going mobile’ with their own wellness app, built with MyVitaLink (note that website indicates a restructuring) that ties into their PHR, and their collaboration with Alcatel-Lucent. Second graph puts mobile companies on infringement notice.