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 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!
[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
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…)
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?)
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 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…)
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)
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…)
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…)
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.
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…)
This event was held on April 28th-30th in Victoria in London. It was organised by Pharma IQ and clearly had a strong pharma focus (including the charge which at £1995 for industry attendees clearly discriminated in favour of those with big-pharma sized budgets). It was also held just a few days after the significantly lower-priced Royal Society of Medicine event, and in the middle of a London Tube strike, all of which doubtless contributed to the relatively modest attendance (26 paid). I am most grateful to the organisers for kindly inviting me as one of speaker Alex Wyke’s guests.
As mentioned in an earlier post, there was a similarity with the RSM agenda, so I won’t repeat comments made by the same speaker before. The first up was the 3G Doctor, David Doherty, who gave another of his excellent presentations, although the sound engineer sadly made some of it inaudible. After a review of how we had got to where we are, he suggested that the Internet is about to become a device-dominated network. He drew a parallel between (more…)
Another part of the 2012 FDA Safety and Innovation Act (FDASIA) clicked into place with the US Department of Health and Human Services (HHS) publishing a draft report proposing strategy and recommendations for what is rather grandly termed a “health IT framework”. Basically it defines more unified criteria, based on risk to the patient and function of what the device does, not the platform (mobile, software, etc.). It then separates products into three broad categories. Excerpted from the FDA release and the FDASIA Health IT Report:
- Products with administrative health IT functions, which pose little or no risk to patient safety and as such require no additional oversight by FDA. Examples: billing software, inventory management.
- Products with health management health IT functions. Examples: software for health information and data management, knowledge management, EHRs, electronic access to clinical results and most clinical decision support software. This will be coordinated largely by HHS’s Office of the National Coordinator for Health IT (ONC) as part of their activities (including their current voluntary EHR certification program), but the private sector is also cited in establishing best practices.
- Products with medical device health IT functions, which potentially pose greater risks to patients if they do not perform as intended. Examples: computer-aided detection software, software for bedside monitor alarms and radiation treatment software. The draft report proposes that FDA continue regulating products in this last category. (Illustration on page 13 of report.)
The report also recommends the creation of a public-private entity under ONC, the Health IT Safety Center, which “would serve as a trusted convener of stakeholders and as a forum for the exchange of ideas and information focused on promoting health IT as an integral part of patient safety.” The private sector is duly noted as a ‘stakeholder’.
The report was developed by FDA “in consultation” with ONC and, not unexpectedly, the Federal Communications Commission (FCC). Another recommendation (page 28) is the establishment of a ‘tri-Agency memorandum of understanding (MOU)’ to further determine their working relationship in this area. There’s a 90 day comment period on the 34 page report, which is perfect for weekend reading (!) How this onion will eventually be peeled, rather than quartered, remains to be seen, as does anything emanating from Foggy Bottom. FDA release. Report. FierceMobileHealthcare.
Update 8 April: A good summary of criticism and approval of the framework to date appears in iHealthBeat from the California Health Care Foundation. The two US Senators sponsoring the PROTECT Act [TTA 28 Feb, 6 Mar] stated there is still too much regulation of low-risk technologies, and Bradley Thompson of Epstein Becker/mHealth Regulatory Coalition believes the report is weak on the issues around clinical decision support software. With praise: HIMSS, Health IT Now Coalition and ACT, which claims to represent about 5,000 mobile application developers and IT firms, but has no locatable website.
Previously in TTA: FDA finally issues proposed rule simplifying medical device classification
Genetic testing company 23andMe seems to be in no rush to resolve its differences with the FDA, and the digitalhealtherati a/k/a D3H (Digital Health Hypester Horde) are wondering why. In late November, 23andMe executives undoubtedly had a depressing Thanksgiving when the FDA ordered them to stop providing health reports (interpretation of genetic results) and marketing kits. Four months later, 23andMe continues to sell its kits for $99, providing only raw genetic data and ancestry reports–and according to its 31 March blog posting, will do so for the foreseeable future as they complete the regulatory review process. The blog quoted CEO and co-founder Anne Wojcicki, “My main priority is resolution with the FDA,” but actions speak louder than words–and the FDA isn’t talking. The FDA standard is still validation–the company has to analytically and clinically validate 23andMe for its intended uses, which is why the FDA took action against them in the first place.
- Is the lack of urgency more about continuing to gather raw genetic and health data unimpeded? Ms Wojcicki had widely stated her real aim was to build a 25-million-strong database (Fast Company).
- Is the real revenue stream of the company not the kits but in monetizing a massive database, selling it to researchers and others (Matthew Herper in Forbes)–the Google model which Ms Wojcicki is quite familiar with? Consider that there’s $126 million into the company, that is a lot of $99 kits.
Most companies in this situation would be imploding. This one is not. Interestingly. FierceMedicalDevices, The Verge
Previously in TTA: all you ever wanted to know about the 23andMe kerfuffle in FDA tells 23andMe genomic test to stop marketing (including this Editor’s analysis of their pre-FDA website with copy breathlessly expressing potentially life-saving or critical lifestyle changing claims, countered by legal ‘educational use’ boilerplate) and The inevitable: class action lawsuit against 23andMe (a check of the Ankcorn blog has no updates)
The FDA has now published its proposed rule simplifying its medical device classifications as directed by the 2012 FDA Safety and Innovation Act (FDASIA). This permits reclassification by administrative order versus the rulemaking (notice and comment) process. (Presumably this rule, as part of the latter process, sets up the process for the former.) In the US, the Food, Drug & Cosmetic Act (FDC Act), which FDASIA amends, has three classifications of devices from least restricted (Class I general controls) through premarket approval (Class III).
As published yesterday in the Federal Register, the class definitions are being amended to balance the assurance of safety and effectiveness with “the level of regulation necessary to provide such assurance should be closely tailored to the risk presented by a type of device.” The long-awaited changes are seen as highly favorable for mobile health devices and apps which for the most part do not fit neatly into the present Class I-III structure. (more…)
IBM Watson crunches the genomics for glioblastoma. A clinical trial at seven locations is being developed in partnership with the NY Genome Center to identify potential treatment options for the most common type of brain tumor–one where diagnosis and treatment time is of the essence. iHealthBeat, Modern Healthcare….Also in NY, Montefiore Medical Center in The Bronx is evaluating several mobile initiatives including a current pilot for texts/care management to support diabetic teenagers, as well as evaluating interacting with diabetics on fitness and biosensor monitoring. FierceMobileHealthcare….Yecco’s social media platform for families caring for older adults [TTA 13 Mar] adds insurance. Allianz Global Assistance UK announced Yecco Home Care insurance, providing up to six weeks of assistance at home following an accident, injury or hospitalization. Release….Six US Senators seek clarification on FDA mobile health regulations. The letter to FDA Commissioner Margaret Hamburg inquired on FDA plans and asked if legislative assistance might be required. The FDA/ONC-HIT framework report originally due in January now has a deadline of 31 March. iHealthBeat. The Hill ‘Healthwatch’….The Samsung Galaxy S5 won’t be considered a medical device by South Korea’s Ministry of Food and Drug Safety. According to Engadget, it was the heart-rate sensor that subjected it to stricter regulations under current South Korean laws. Oy….And it took a while, but finally the Tunstall Americas management page lists new CEO Casey Pittock at the top! (No release yet though.)