When it comes to new technologies–and drugs for that matter–the worst thing that can happen to your invention is to receive a letter from FDA that you have been classified into Class III. Based on regulations passed by Congress in 1976, there are three FDA classes primarily based on device risk. Exception: Class III. Anything not ‘substantially equivalent’ to an existing device is automatically put into Class III, regardless of risk level. Author and health tech legal advocate Bradley Merrill Thompson of Epstein Becker Green takes a comprehensive review at this flawed and outdated system that puts groundbreaking health tech at an extreme disadvantage in his latest article on regulation in Mobihealthnews. (more…)
Avoiding the FDA health IT-medical device regulatory trap for general IT companies (US)
If you are an IT company in the US or internationally with services which could be useful to healthcare companies or practitioners, it’s easy to be overly specific and stray into FDA-regulated territory. The always-informative Bradley Merrill Thompson of the Epstein Becker Green law firm delineates the fine regulatory line that general purpose IT companies must observe when working with healthcare customers. First there is intended use, based on how the manufacturer intends its customer to use the product; if the customer uses it for the diagnosis or treatment of disease or other conditions, FDA will regulate it as a medical device. This is less clear than it seems, and Mr Thompson explores where a general IT company can, in the old PR adage, ‘say it safely’ and avoid falling into the unwanted medical device trap by avoiding medical feature and advice claims, and keeping the context away from medical use. The Journal of mHealth (August)–online version, optional PDF download. Hat tip to Mr Thompson via the Continua LinkedIn group. Other articles of interest in the JMH are: Scottish company HCi Viocare and its ‘smart insole’ pressure sensors for foot ulcer detection following, Northwestern University’s research around patterns of smartphone usage detecting depression (page 19) and a lengthy article on transforming patient data into actionable insights (page 34).
Pharma company ‘breaks the Internet’ with Kim K, gets FDA testy
But it may break them…well, give them a fracture. Or a good hard marketing lesson. Specialty pharma Duchesnay thought it had hit the jackpot with negotiating a promotional spokeswoman endorsement from pregnant celebrity Kim Kardashian of its morning sickness drug Diclegis. The Kardashian Marketing Machine cranked up. Kim (and mom Kris Jenner) took to Instagram, Facebook and Twitter in late July with (scripted) singing of Diclegis’ praises to their tens of millions of followers. The Instagram posts linked to an ‘important safety page’ a/k/a The Disclaimers. That wasn’t near enough for the Federal Drug Administration (FDA) which governs the acceptable marketing of all drugs in the US. On August 7th a tartly worded letter arrived at Duchesnay’s Pennsylvania HQ cited multiple violations of marketing regulations, notably risk information, and told Duchesnay to cease these communications immediately or withdraw the drug, which would be highly unlikely as it is successful. They also were require to provide “corrective messages” to the “violative materials”.
Our takeaway:
* Duchesnay reaped a bounty of free media (see below), on top of the (undoubtedly expensive) Kardashian endorsement. Yes, they did pay the cost of a FDA nastygram and a legal response, and the warning will live on in their file. However, a lot of target-age women now know Diclegis and others know about the relatively obscure Duchesnay.
* This was a calculated marketing risk that tested the boundaries of social media and celebrity endorsement. (more…)
Smartphone and sensors the latest ‘medic’ for diagnosing battlefield TBI
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/07/Ahead-200.jpg” thumb_width=”150″ /]Finally a more reliable device for combat medics to screen for TBI in the field. The US Department of Defense, before its EHR bombshell (so to speak) yesterday, issued this short Armed With Science article on a sensor-smartphone for quick field diagnosis of TBI. The FDA-cleared BrainScope Ahead 200 marries an Android smartphone with a headset and disposable sensors to measure brain electrical activity, The app in the smartphone then analyses the brain data using algorithms to correlate them to elements relating to TBI. Currently, most combat-related TBI tests are subjective, based purely on symptoms such as headaches, nausea and light sensitivity. The only ‘objective’ test would be a CT scan in a medical facility well off the front lines, which means time wasted in a definitive diagnosis. This is being implemented by the Army Medical Research and Materiel Command at Fort Detrick, Maryland.
Do startups truly threaten the ‘healthcare establishment’?
Or are successful startups fitting into their game? Chris Seper in MedCityNews paints the picture of one side of a quandary. The ‘healthcare establishment’ fundamentally and to its detriment does not understand and is threatened by the startup and innovation process. A startup may begin with an idea which is, in his words, ‘almost always flawed, sometimes deeply’. If the founders are smart, they will test their ideas, validate them and change them appropriately. If not, they will fail. But it is easier for the Establishment to point at the most egregious of the bad ideas and use them to rationalize the status quo.
But being congenital contrarians, we paint the house on the other side of the street. Has the Establishment caught up with–or in some cases, co-opted startups, making them and their funders ‘do their diligence’ and be more cautious before emerging? This Editor would argue yes, and largely for the better.
**The ‘Wild West’ days are over. A few years ago, a truly bad or deeply flawed health tech idea or could easily find funding, because it was all blank slate, new and ‘transformative’.The sexiest hooks were Quantified Self, sleep, employer health incentives, interactive coaching, genomics, app prescribing and (last) wearables. A lot of founders imagined themselves as the Steve Jobs of Healthcare, down to the black turtleneck. Now there is a history of success and failure. The railroads reached the dusty frontier towns.
**There’s now a ‘Startup Establishment’. National accelerators (more…)
‘Separating the wheat from the chaff’ in medical apps daunting: JAMA
Medical apps may not be strangers to doctors’ offices anymore but they also realize that apps are difficult to recommend responsibly to patients or even to find, because there is no real guidance or validation. This current article in JAMA online confirms the perception and the need for care integration that both Editors Charles especially and Donna have pointed out lo these many years. However this Editor is quite disillusioned at the attempts to date to ‘curate’ apps with the Happtique failure and the relatively low profile to date of IMS Health’s AppScript and professional review site iMedical Apps and the stated intentions of SocialWellth which purchased Happtique. The reality is that the numbers are against it–IMS Health in their study estimated 40,000 medical apps–in 2013. For apps that want to take the high road, it’s economically difficult, but could be rewarding in the long term. The WellDoc BlueStar diabetes tracking and management support app did with FDA clearance and prescription-only use, but few so far can see a revenue model there. Also MedCityNews.
Intended use determines degree of health app regulation–and also how you communicate your attributes and performance claims. Bradley Merrill Thompson, who performs an invaluable service by advising our field on regulation, compliance and interacting with FDA, demonstrates how a developer can determine where the intended use of an app might fall (more…)
HIMSS Monday highlights
HIMSS is the largest US healthcare conference in the world, and Neil Versel, who has just joined the staff of MedCityNews, reported that registrations in this year’s event in Chicago were in excess of 40,000. He has a 37 minute interview with HIMSS Executive Vice President Carla Smith where they touch on CMS, Meaningful Use, EHR interoperability, data security, patient engagement and the empowered patient such as E-Patient Dave deBronkart (who will also be at The King’s Fund Digital Health conference in June). HIMSS is also showcasing on the show floor mobile health, interoperability, cybersecurity, disaster preparedness, intelligent health and the connected patient….Another sign that the Wild West days of digital health are over is the increasing oversight of the Federal Trade Commission (FTC) on non-HIPAA regulated health data collected by fitness and wellness devices. This is in addition to health apps making unsupported claims (see today’s and previous articles on melanoma detection apps) and the PaymentsMD patient billing software that was collecting a little extra patient data. This is both extra- and in addition to FDA. Mobihealthnews….. The Venture+Forum on Sunday discussed doctor burnout particularly in acute care and to ease this, focusing on the Holy Grail of proactive rather than reactive care and results rather than ‘shiny new objects’ (what this Editor has called Whiz-Bang Tech) “Doctors want clinical decision execution. Don’t give me any more tools.” Healthcare IT News….A survey by Accenture released today on doctors and EHR usage headlines good news–79 percent US doctors feel more proficient in their EHR usage than in their 2012 survey. The bad news is that other numbers are plummeting: fewer believe that EMR has improved treatment decisions (46 percent in 2015 vs. 62 percent in 2012), reduced medical errors (64 vs. 72 percent) and improved health outcomes for patients (46 vs. 58 percent). Familiarity breeds contempt? Buried way down in the release is that US physicians offering telehealth monitoring to patients has tripled since the last survey, from just 8 percent in 2012 to 24 percent now. Accenture surveyed over 2,600 physicians in six countries….HIMSS goes to Thursday, so more to come!
23andMe’s FDA coup hazardous to personal DNA data security?
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/03/DNA-do-not-access.jpg” thumb_width=”150″ /]Genetic test developer 23andMe’s wins with the FDA [TTA 20 Feb] served to clear the path for their current Bloom Syndrome and future kits as Class II devices. It’s long been believed that the company’s real diamond mine is in selling the DNA data gained through the kits, and with consent, to major pharma and medical companies. Proof: recent collaboration announcements with Genentech and Pfizer on genetic research. But how will this data be safeguarded? It may not be a significant concern now, but “Personal DNA information will become far more critical and more important to safeguard than the details of our life circumstances”. Hackermania’s Running Wild with AnthemHealth-sized data breaches (more…)
23andMe finally gets a nod from FDA
Breaking news: Foot in door? Crack in the wall? This week’s Big News among the genomics enthusiasts among the healthdigerati is that 23andMe finally got one test through FDA, for Bloom Syndrome where the gene is carried by both parents, and now can freely sell the kits. Much is being made of wording in the press release from a major FDA executive as opening the door:
“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information. Today’s authorization and accompanying classification, along with FDA’s intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children.”
But far more of a startling admission by FDA is that 1) these genetic screening kits are now classified as Class II and 2) they intend to exempt them from the arduous pre-market review that is in Class III:
Along with this authorization, the FDA is also classifying carrier screening tests as class II. In addition, the FDA intends to exempt these devices from FDA premarket review. The agency plans to issue a notice that announces the intent to exempt these tests and that provides a 30-day period for public comment. This action creates the least burdensome regulatory path for autosomal recessive carrier screening tests with similar uses to enter the market.
There will be much more; this article by Chris Seper in MedCityNews is an excellent recap. Our articles previously in TTA.
Would one of our UK readers expand our knowledge on these kits’ regulatory status in the UK and EU? According to the MedCityNews article, the UK permits 23andMe’s genetic testing, but is vague on the details (CE approval?)
FDA final guidance on mHealth eases regulation of MDDS, mHealth (updated)
As anticipated, FDA issued final non-binding recommendations for guidance yesterday (Monday) that ease regulatory oversight of medical device data systems (MDDS), including image storage and communication devices, and mHealth devices.
In the MDDS guidance document, “(FDA) does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health.” It defined MDDS as “a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) The electronic transfer of medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) The electronic display of medical device data.” along with their hardware and software. It specifically excludes devices that are used in active patient monitoring.
Mobile health apps were covered in a separate and highly detailed guidance document, “Mobile Medical Applications”.
- FDA will regulate only “those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.” (more…)
Looking back over Telehealth & Telecare Aware’s predictions for 2014
Looking back over our predictions made on 31st December last year, it’s hard to quibble with any, and worth hanging on to those that didn’t come good this year.
Our first was
Security and data privacy issues will become a serious mHealth issue in 2014; developers failing to take great care over security and privacy issues will risk very adverse publicity and worse.
Job done: that certainly proved correct, with many being exposed as either selling or potentially selling private information. Clinicians were not immune from privacy invasion either. Here is a US summary of the issues. Attention was drawn to an EU Article 29 data protection opinion (actually published in 2013) that sought to clarify the legal framework applicable to the processing of personal data in the development, distribution and usage of apps on smart devices, and the obligations to take adequate security measures. Many apps got hacked too, including FDA-approved ones. There were also items, such as this one, demonstrating how complex the law is in this area in the US. In the EU, the arrival of the Data Protection Regulation in 2015 (now some say 2016) will undoubtedly improve data privacy significantly, though the failure to treat data used for health purposes differently from (more…)
Concise analysis of mHealth regulatory environment (US)
If you–like most rational people–have some confusion in deciphering the current FDA state of affairs as it applies to mHealth, this summary from major law firm Foley & Lardner will be helpful. Written by special counsel for healthcare/mobile health Monica R. Chmielewski, it defines in few words FDA’s classifications, which mHealth technologies are, and which are not, subject to FDA oversight. In particular, MDDS (medical device data systems) were recently downgraded from Class III (the greatest oversight with pre-market approval) to Class I. FDA has also recently finalized recommendations in a guidance document for medical device manufactures for managing cybersecurity risks. mHealth Technology – Development in an Uncertain Regulatory Climate (Health Care Law Today)
Roundup: data breaches ’round the world
Following on our review of recent articles on why medical identity theft is so attractive, here’s our review of data breaches in the news, including a new (to this Editor) report from Europe.
- It’s not Europe, blame the UK! That is one of the surprising findings of a meta-review of all types of data breaches released earlier this month by the Central European University’s Center for Media, Data and Society (CMDS). While not specific to healthcare, it is the first study this Editor has seen on EU data breaches and is useful for general trends. 229 verified incidents were analyzed by the CMDS across 28 EU member countries plus Switzerland and Norway, 2005-3rd Quarter 2014, and includes unusual healthcare breaches such as Danish HIV patients’ personal information included in a PowerPoint presentation later published online. Key findings:
- 57 percent of breaches were due to insider theft, mismanagement or error; 41 percent were hacker-instigated
- It’s common: “for every 100 people in the study countries, 43 personal records have been compromised”
- In terms of impact, the UK by far, then Greece, Norway, Germany and Netherlands were the top five countries for incidents and numbers of records breached (report page 9) (more…)
Funding, granting and executive moves
Summer hasn’t been beach holiday time for some of the companies we’ve been following….Genetic testing for the masses 23andMe, only last fall in much hot water with FDA (but recently making nice–TTA 2 July), received a two-year, $1.4 million grant from the National Institutes for Health (NIH). iHealthBeat….’Smart pill’ developer Proteus Digital Health received a Series G round of $52 million, adding to a June round of $120 million. Investors not disclosed, but Proteus currently has a blue-chip list including Novartis, Medtronic and Kaiser. BusinessWire….Pre/post-procedure education and recovery monitoring service VOX Telehealth received another $1.1 million round of angel financing primarily from original investors, preliminary to an institutional round of financing in 1st Quarter 2015. Release….HealthSpot Station is reinforcing its retail reach (more…)
23andme and FDA: making nice?
In a reversal from the ‘¡No pasarán!’ (‘They shall not pass!’) position 23andme and its QS fans famously took back in the winter and spring [TTA 2 Apr, with prior links] vis-a-vis FDA on interpretation of genetic tests, this report from VentureBeat indicates that 23andme is holding out an olive branch. It’s not your usual cutting. It’s an application for Bloom’s Syndrome, a rare inherited genetic disorder, which FDA just accepted. Adding to it is that CEO Anne Wojcicki is a carrier of this disorder. VentureBeat’s speculation is that if successful, the Bloom’s Syndrome application would be the template for future test applications. The tone on both sides has grown conciliatory. For example: sitting on the same Congressional panel on healthcare last Tuesday was an FDA physician directly involved in the approval situation and Ms Wojcicki. There was a well-timed, quite emollient interview with Ms Wojcicki in the Wall Street Journal this past weekend. Certainly a factor is that 23andme is still growing, but less quickly–up 150,000 from its pre-FDA contretemps level of 550,000. And its funders, even though closely related to Ms Wojcicki, hate to wait on numbers which are certainly below projections.
mHealth: too much to blog, too little time
As always the question is where to start? Perhaps with the FT headline ‘Powerhouse’ UK leads Europe app development, says research, a piece by Daniel Thomas on some research sponsored by Google & Tech City UK. A full version of the report is here. Key findings are that the UK:
- Has become the largest tech hub in Europe for app development;
- Received a third of revenues generated from mobile software in Europe last year;
- Is the base for almost a fifth of European developers of smartphone applications;
- is believed to be the world’s second most important tech hub after the US;
- Has about 8,000 companies involved in app development, employing close to 400,000 people.
Apparently almost half of app developers and designers in the UK generate most of their income from apps, although a fifth generate no income from apps at all but rather see them as a hobby.
Staying with the FT, Prof Mike Short has kindly also pointed this editor to another article entitled (more…)
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