Epic Systems getting into the app store business (US)

Epic Systems, the #1 company in the hospital and large practice EHR business, is launching its own app store, reportedly within a few weeks. This opens up interesting possibilities not only for mHealth app developers–who need application standards and guidelines soon–but also for Epic’s reputation as a closed system that shies away from interoperability with other EHRs like Cerner, Meditech and McKesson–a serious wrinkle with their Department of Defense EHR joint bid with IBM to replace AHLTA. The HIT Consultant article quotes a leading Epic customer consultant on that the first apps will be clinical, then crossing over into consumer; the latter seems an obvious move with PHRs (personal health records) as part of Meaningful Use requirements.

American Telemedicine Association (ATA) 2015

2-5 May 2015, Los Angeles Convention Center, 1201 S Figueroa Street, Los Angeles, California 

ATA’s annual meeting for 2015 connects like-minded telemedicine, telehealth, mHealth professionals and entrepreneurs from around the globe. With over 6,000 attendees, 13 educational tracks and the largest telemedicine trade show in the world, the ATA meeting is a premier forum to learn and network, featuring:

For more information and to register, see our special link here. Telehealth & Telecare Aware is pleased to be again an official media partner of this year’s ATA. 

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?)

American Geriatrics Society: call for technology startups

The American Geriatrics Society (AGS), the US association of physicians and other healthcare professionals who care for older adults, is inviting startup technology companies to a special exhibition area during their annual meeting 15-17 May in Washington DC (National Harbor). Along with a modestly priced display in the Technology Innovations Pavilion, 12 companies will also receive feedback and coaching sessions with geriatrics clinicians plus full conference access for two. Companies are selected on the basis of their application and the value of their technology to geriatric patients and caregivers. Applications are open until 15 March and apparently are not restricted to US companies. AGS page, application  Hat tip to Wen Dombrowski, MD, of Resonate Health.

Integrating technology into med school education (US)

Medical students today enter their training oriented to technology, tablets in hand, but medical education usually does not integrate technology into practical use, particularly in the science-intensive first two years. Here are three med schools which are making an effort to do so:

  • Hofstra-North Shore LIJ in Long Island, New York has new students spend their first eight weeks not in lecture classes but becoming certified emergency medical technicians (EMTs). This Editor guarantees they will have a greater appreciation for emergency medicine and patients needs after this.
  • Penn State-Hershey, a major medical system in eastern central Pennsylvania, has their first-year students work as “patient navigators,” helping them and their families get through the medical system and learning about it, from the patient perspective, first-hand. The article doesn’t specify, but presumably they will learn something about how EHRs work (or not), PHRs and the pre/post-discharge process.
  • NYU School of Medicine has a course using a database that tracks NY admission and charges. Students then analyze service and cost disparities. (Nice, but seems like a distraction to the basic crunch work.)
  • Mayo Clinic is converting much of the traditional lecture material to electronic formats for its two medical schools for greater accessibility.

However, under the tent flap of improvements also comes sheer, screaming puzzlements (more…)

An alert watch for older adults that responds to voice commands

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/02/UnaliWear_Images_r6_c4.jpg” thumb_width=”150″ /]This Editor has been in Watch Overload (see Apple Watch) for months, but this may be an exception. The UnaliWear Kanega watch (in development) is for the sizable market of older adults who would wear a well-designed watch or band for safety assistance, but not one that screams Old Person With Plastic PERS, an objective shared with the latest edition of buddi [TTA 16 Dec 14]. Their prototype looks like a fairly techno steel watch, a little on the chunky side, but it packs in a lot: a 9-axis accelerometer for fall detection, a GPS locator, Bluetooth LE, cellular/Wi-Fi connectivity and a digital analog display with time and date. What’s unique: no buttons, smartphone or other tether. It works via speech recognition and ‘talks with’ the wearer (via mechanical voice, messaging on the display and a feed to a BLE hearing aid if worn.) (more…)

Apple Watch may not be as ‘healthy’ as touted

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/09/apple-watch-beauty-shot.png” thumb_width=”150″ /]According to multiple press sources in the past 24 hours, the anxiously-awaited Apple Watch is rumored to be having big trouble with its more advanced healthcare measuring features. We noted at the time “Haptic engine and heart rate monitor; 4 lenses. infrared, LED, photo sensors detect pulse.” plus daily activity [TTA 9 Sep, 11 Sep 14]. Well, not quite. The Wall Street Journal broke the news that it will not debut in April including monitoring of “blood pressure, heart activity and stress levels” as originally planned because, simply, the watch did not measure them reliably and accurately (hairy, sweaty arms!), they were too complex or required regulatory approval (not so–see FDA and MDDS).

Apple has relied on the Watch to defend its Still Most Innovative Company Post-Jobs turf, (more…)

Healthcare Innovation Breakfast Series (Dallas, Texas)

Having met and been impressed at mHealth Summit by Health Wildcatters [TTA 26 Apr 13], a Dallas Texas-based healthcare accelerator, they are doing some smart marketing in sponsoring a series of local networking breakfasts called The Pulse to connect entrepreneurs, medical professionals, and other innovators from the thriving Dallas healthcare and business communities with healthcare startups. Their launch is Thursday 26 February from 7:30-9am. Coffee and continental breakfast is provided and the cost is an affordable $15. Reserve hereHat tip to Hubert Zajicek of Health Wildcatters via Twitter

Tech, approaches for caregiving at a distance falling behind

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/02/8001846820_6d2df50ffa_z.jpg” thumb_width=”175″ /]There’s plenty of telehealth systems and apps that remind older adults of their meds, appointments and take their vital signs–but where are the ones that take care of the reality of ‘aging in place’: the loneliness of the man or woman who lives alone, how that person can communicate with family with their own lives 50 or 2,000 miles away, how family members can better oversee or coordinate her care? The problem hasn’t changed when first addressed over a decade ago by the earliest telecare systems. The technology, while more abundant, is largely uncoordinated, putting the burden on the caregiver. Laurie Orlov points out that ‘finding care is not the problem’ but that the care is at extremes: either too light (daily non-medical assistance) or a move to assisted living housing (average move-in now 80+). No company has truly organized a larger solution (more…)

Your robot update for Tuesday

Catching up on our robot friends (?), we have a potpourri of developments which concentrate on either improving health or advancing robotic capabilities:

The ASSAM (Assistants for Safe Mobility) project is not about tea, but assisting older adults with everyday mobility and facilitating autonomy centering on physical mobility assistance for declining walking capabilities, but encouraging physical exercise; cognitive assistance for declining visual and mental capabilities by obstacle recognition and avoidance, and orientation and navigational aid. ASSAM upgrades existing DME (durable medical equipment) via sensor and computing hardware/software packages. It is coordinated by the German Research Center for Artificial Intelligence (DFKI), and receives funding from the EU’s Ambient Assisted Living Joint Programme and the national ministries of Germany, Spain, and the Netherlands. ASSAM website, YouTube video  Hat tip to the German Center for Research and Innovation

A robot scientist may make ‘orphan drugs’ an obsolete term. Eve, a robot scientist (more…)

A primer on why startups fail

What makes for a successful startup? Or the converse–what are the Elements of Doom for all those Better Mousetraps? Since many of our Readers have Been There, Done That or Considering That, this blog posting by David Skok of VC Matrix Partners (with only minor holdings in healthcare) could be illuminating. Five factors are detailed succinctly and in plain English: market problems (timing, value proposition), business model failure, poor management, running out of cash and product problems. The calculation of CAC (Cost of Acquiring Customer)/ LTV  (Lifetime Value of Customer) with a multiple of CAC:LTV at 1:3-5+ essential. To this Editor, these Elements also apply to later stages. For Entrepreneurs, “Why Startups Fail.” Hat tip to MedCityNews via Twitter.

TripleTree iAwards: applications open

Applications are now open through 13 March for the seventh annual TripleTree iAwards, which recognize the most innovative companies in connected health. Finalist CEOs present at the 10th annual Wireless-Life Sciences Alliance (WLSA) Convergence Summit 26-28 May in beautiful (and warm) San Diego. Previous finalists are a chronicle of the changing connected health scene: marquee names still with us (Qualcomm Life, AliveCor, GreatCall, Proteus)–and those vanished from the scene (Healthrageous, WellAWARE, Diversinet, Zeo). Information and application.

Integrating spiritual care into healthcare: conference (US)

2015 Caring for the Human Spirit, 20-22 April, Walt Disney World Resort, Orlando Florida

The Health Care Chaplaincy Network (HCCN), which we’ve recently profiled in ‘Chaplain Care for Veterans’, has been integrating online and tele-consultative (email, phone and video chat) resources into spiritual and mental health care in chaplaincy service. This year’s conference highlights include a workshop on TeleChaplaincy: The Online Practice of Professional Chaplaincy. Featured speakers are primarily from the US, but include The Rev. John Swinton, University of Aberdeen, King’s College School of Divinity. Conference registration is also available for a real-time webcast of all sessions and workshops. Brochure  Previously: Patient engagement meets ‘palliative care’ in a care plan pilot with VOX Telehealth [Disclosure: Editor Donna is a volunteer on the HCCN’s marketing advisory council.]

Hackermania running wild, 2015 edition

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/02/Hackermania.jpg” thumb_width=”300″ /]

Do we need the Hulkster Running Wild against Hacking? It’s so heartwarming to see the mainstream press catch up to what your Editors have been whinging on for the past few years: that healthcare data is the Emperor With No Clothes. Here we have Reuters and the New York Times with a case of the vapors, seeking a fainting couch. Reuters dubs 2015 ‘The year of the healthcare hack’. The FBI is investigating the AnthemHealth breach, while their counterparts UnitedHealth, Cigna and Aetna are in full, breathless damage control mode. The Times at least delves into the possibility that it was at least partially instigated by China and the People’s Liberation Army (PLA) unit that trolls for intellectual property.

Our Readers, savvy to your Editors’ warnings since at least 2010, were aware that the drumbeat accelerated this past summer. (more…)

Data breach fail at AnthemHealth: an inadvertent ‘inside job’ (updated)

US health insurance giant AnthemHealth, which had a data breach of reportedly up to 80 million beneficiaries [TTA 6 Feb], was an inadvertent ‘inside job’. The Associated Press reported that the credentials of at least five employees were used to access information, at least one of whom was an administrator who viewed his credentials being used to query the data warehouse. It’s easier than you think to get them. In an analysis published by security firm Tripwire and also in MIT Technology Review, the writer Ken Westin outlines how easy it is to find that the Anthem warehouse is TeraData, and to match up employees engaged with it, through using public employee profiles on places like LinkedIn and job postings. Then it’s deductive to find exact email addresses (find the pattern–lead generation companies building business contact lists do this all the time) and send these key employees phishing emails  (more…)

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…)