FDA finally issues proposed rule simplifying medical device classification

March 26, 2014 | by

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…)

Pacifying baby, taking temperature

March 26, 2014 | by | 2 Comments

UK developer BlueMaestro has announced a temperature-sensing baby pacifier with the somewhat obvious name Pacifi. According to Mobihealthnews (but frustratingly not on their website), the pacifier sends temperature data via Bluetooth Smart to an iPhone or Android app. Parents can record medication dosing and reminders, track temperature and medication over time, and set up an alarm when baby runs a high predetermined temperature. It’s also dishwasher safe. Pacifi joins Raiing Wireless‘ body thermometer FDA cleared in 2012 (now iThermometer) and Kinsa’s plug-in smart thermometer which took a crowdsourcing approach to local public health. It is not cleared for sale yet in the UK or US, but was shown at last month’s Mobile World Congress Barcelona and the Smart UK Project in London. Unfortunately, it may be a while before Quantified Self Moms can put it on the list for their baby showers, along with the Owlet monitoring sock, Mimo onesie and iTeddy [TTA 10 Sept]. Related: MedCityNews compares Mimo to adult sleep monitor Lark, awarding the matchup to Mimo. The real matchup is Owlet versus Mimo (see this Editor’s comment). (Also see our comments here discussing the safety of RF monitoring around babies.)

The CES of Health (Thursday)

January 10, 2014 | by

Beaucoup fitness bands and wearables, an ‘all-in-one’ glucose meter and finally, a lack of hype!

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/01/razer-nabu-main-banner.jpg” thumb_width=”150″ /]Mobihealthnews rounds up 18 mobile health launches in a slideshow format (a bit difficult to page through). It’s heavy on fitness monitor bands and wearables from well-known and startup companies at price points from the $100 range up well past $400:  Sony, LG, Garmin, Polar, Razer, Virgin Pulse (clipon), Lumo, iFit, Movea, Wellograph and Epson. (Also see Medgadget’s roundup if you can’t get enough!) Outside of fitness monitors: from China’s iHealth Lab (Andon Health), a blood pressure monitoring vest, an ambulatory ECG device that supposedly sticks to the wearer’s bare chest (no FDA approvals yet); Zensorium Tinke’s pulse oximeter plus for Android (seen by this Editor at New York CES in November 2012), the Qualcomm Life-backed YoFiMeter cellular glucose meter (more below) and the Medissimo Medipac GPS tracking pill box from France. Already covered here: Withings Aura, Qardio, Mother, Kolibree. (more…)

NYeC Digital Health Conference 2013: the trends

November 16, 2013 | by

Updated 21 November

The third annual New York eHealth Collaborative (NYeC) Digital Health Conference in New York City attracted several hundred people from the worlds of hospitals, public health, academia, policy makers and health insurers–and the myriad related products and services which will enable these entities to improve their health IT, organization and engage patients in their own health. If there were three buzzword phrases setting the tone, they were interoperability, patient portals and technological innovation. All relate to data–data transfer of patient records between providers to be available regionally (RHIOs) and throughout the state via the SHIN-NY health information exchange (HIE); using data to help people visualize and improve their health;  putting data into ‘whole person’ context for providers, integrating it into workflows and to save lives; using data to serve process improvement and tougher standards. And finally there is that old devil cost: reducing the cost of care, reducing expensive readmissions plus co-morbidities and making those tools to do this job more affordable for providers and patients.

NYeC has developed considerably since its early days seven years ago (more…)

Depressed? A woman? There’s an app for that.

November 12, 2013 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/11/T47screen-166×300.png” thumb_width=”130″ /]A new app still under development, Thrive 4-7 (the 7 is the seven dimensions of health) is meant to be used as a supplement to traditional therapy (and presumably medication). The app ‘thrives’ on constant interaction and uses gamification (!), behavioral psychology and influential design to modify the user’s behavior, for instance by sending special messages at times of daily stress. The developers want to connect the app with wearables and peer support groups as well. However, the time of their in-market–best case scenario is a debut at the end of 2014– is dependent on FDA clearance if it’s required–yet to be determined. The business plans, depending on this, may be direct to consumer or sold through health plans, hospitals and employer groups. The therapist you sleep with (MedCityNews) does seem like encouraging an unhealthy behavior, though.

mHealth for Behaviour Change

October 24, 2013 | by

4 December 2013, Holiday Inn Regent’s Park, Central London, UK

SMi’s masterclass hosted by David Doherty of 3G Doctor will cover the following:

• Introduction to how mobile is changing behaviour (positive & negative)
• Overview of available mHealth technologies
• Lessons from previous research efforts
• Ways Healthcare Providers are leveraging Mobile Technology to change behaviour
• Deep dive on world leading program that uses mHealth tech to manage Chronic Disease
• Insights into how to design for sustainable behaviour change

Information and registration.

Wireless Health 2013 (US)

October 24, 2013 | by

1-3 November 2013, Johns Hopkins University-Carey Business School, Baltimore, Maryland

Presented by the San Diego-based Wireless-Life Sciences Alliance (WLSA), the trans-disciplinary focus of the conference, crossing research, development and implementation lines, will bring together members of the medical and health research community, device manufacturers, clinical and health services providers, government leaders and policy makers. Peer-reviewed papers and abstracts, interactive workshops, emerging application demonstrations, and distinguished speakers will be featured. 1 November features pre-conference workshops. Keynoters include Dr. Michael Roizen, Chief Wellness Officer and Wellness Institute Chair at the Cleveland Clinic, Dr. Peter Tippet, Chief Medical Officer and Vice President of the Verizon Innovation Incubator, and computer/healthcare scientist Deborah Estrin of Cornell NYC Tech. Release.  Information and registration here.

Humana, Healthrageous and some object lessons

October 16, 2013 | by

The acquisition of the assets of Partners HealthCare spinoff Healthrageous by insurance and health service giant Humana is reverberating in the field in the US, particularly those in the buzziest digital health sectors. Some may look away, but a hard look provides some object lessons at the sheer unpredictability of the field for those who are innovating and attempting to shape consumer behavior and health. (Not behavioral health)

  • Healthrageous had an impressive lineage and credibility. Developed over three years at Partners HealthCare, it was spun off in 2010, PHC members on the board, leadership from well-known/regarded figures such as Rick Lee and Mary Beth Chalk–and enjoyed abundant, rapid startup funding–$12.5 million in two rounds, the last exactly one year ago, from equally impressive investors, reportedly $15 million total. No raiding the credit cards here.
  • It occupied what everyone for the past few years thought of as a sweet spot–personal health management targeted to employers/benefit managers along with health plans to lower costs that combined sensor-based telehealth data with individualized coaching and feedback–and data from a broad base of 10,000 users. (more…)

ITS 2013/UIST 2013

September 30, 2013 | by

University of St Andrews, St Andrews UK 6-11 October 2013

Both ITS 2013 (The ACM Symposium on Interactive Tabletops and Surfaces 2013, 6-9 October) and UIST 2013 (the 26th ACM Symposium on User Interface Software and Technology, 8-11 October) will be co-locating at the University of St Andrews. Worked into the presentations–demos and papers– of new and emerging tabletop and interactive surface technologies is healthcare content; demos at ITS such as The SimMed Experience: Medical Education on Interactive Tabletops and The fun.tast.tisch. Project – Interactive Tabletops in Neuro-Rehabilitation. (more…)

Why HIT CIOs breakfast on aspirin

August 28, 2013 | by

CIO has an excellent summary of how HIT is attempting to cope with the tidal wave of mHealth. Moving away from the ‘look up, receive alerts’ passive mode versus being able to enter data on that mobile device (whether BYOD or hospital issue) means having to focus on architecture, infrastructure and governance priorities (rather than one-offs), fitting mobile into workflows (field discovery of clinical needs), alignment of IT with line-of-business departments and figuring out how patient engagement really works plus how it fits into the previous (and it’s not the hype of what developers would like to see and sell.) Healthcare IT Struggles to Keep Up With Mobile Health Demands