Analysis: The Significance and Insignificance of the FDASIA HIT Report

By: admin | Apr 8, 2014        

Tags: | | | | | | | |  |

By Bradley Merrill Thompson

Bradley Merrill ThompsonI don’t know about you, but when I read the FDASIA Health IT Report released by HHS on April 3, I found it to be largely quite predictable.  Indeed I’ve been scanning the media coverage of the report and I haven’t seen anyone so far express shock or surprise at what was in the report. How is it that we all pretty much knew what would be in there? Quite simply the three agencies that wrote the report – FDA, ONC and FCC – studiously and carefully drew upon the prior work of a large number of organizations. They very specifically incorporated the work of the IOM Committee on Patient Safety in Health Information Technology, as well as the FDASIA working group that Congress had asked the agency to convene. Indeed the new center described in the report is actually already accounted for in the government’s fiscal 2015 budget.

So if there’s very little new in the report, is that good or bad? Yes…  A bit of both. On the plus side, it shows that these federal agencies are listening to an awful lot of very smart people. They are listening to medical and other experts enlisted by the IOM, they are listening to the public’s input as obtained through the FDASIA process and they’re listening to people on Capitol Hill. More on that later.

So why am I not completely happy? Well, I suppose I wanted more. Let’s take a deeper look.

Major Features of the HHS Strategy

If you really want to understand the report, you probably ought to read the 32 pages yourself. But I’ll give you the Reader’s Digest version here.

A three-tiered system

At a high level, the report says that health information technology can be stratified into three levels. Whoever originally thought of stratifying risk into three levels – high, medium and low –probably 1,000 years ago should have trademarked it because now everybody thinks about risk that way. For example, traditional medical devices are stratified into class I, II, and III based on risk. So in the new vocabulary of the report, we divide all HIT into three risk levels as follows:  Keep reading>>


Kognito taps American Academy of Pediatrics for childhood obesity education app

By: Aditi Pai | Apr 8, 2014        

Tags: | | | | |  |

Change TalkNew York City-based patient engagement company Kognito has partnered with the American Academy of Pediatrics (AAP) Institute for Healthy Childhood Weight (IHCW) to create an app that addresses childhood obesity, called Change Talk: Childhood Obesity.

“The goal of the app is really to help healthcare professionals who work with pediatric populations to know how to manage challenging conversations with their family around changes in their behavior,” Kognito CEO Ron Goldman told MobiHealthNews. “This could be anything from diet to exercise to screen time. Really anything revolving around risk factors of obesity.”

The app helps physicians practice talking to patients and their parents about childhood obesity using motivational interviewing (MI), an evidence-based patient-focused technique meant to use motivation to change a patient’s behavior. So far, the app only provides one situation that physicians can play through, but Kognito plans to work with the AAP to add more situations to the app.

In this first situation, the physician is talking to a mother and her overweight son about changing the child’s daily regimen so that he can be healthier. The mother is also grappling with her own health issues so she is unwilling to admit her son might also have the same problems and the son has been bullied at school because of his weight and feels sensitive about the topic.

As the physician talks to the virtual patients, he or she can see a status bar over the patients’ heads that shows whether the conversation is providing the patients with motivation to change. Patients will also change their facial expressions based on how the conversation progresses. If the conversation didn’t go well, physicians can also hit the undo button and try a different approach. The conversations are meant to last about five minutes, which Goldman said is typical of these types of appointments.

Although this conversation is very specific, Goldman said the tactics that physicians are learning in the sessions can be generalized and applied to many more situations. The next situation that Kognito plans to add to the app will be direct to consumer.

“What we already hear a lot is the need to look at the patient and caregiver and the challenging conversations that they need to have within the family and with others around making the changes,” Goldman said. “I think if I had to make a guess, I would say that the next conversation will look at the consumer or the caregiver as a role that you assume in the conversation. For example, in this one you talk to the mom and son at the pediatrician’s — ok you’ve convinced them to make the change. The mom goes back home, she starts talking to her husband about, ‘Ok, we need to make this change, we can’t drink so much soda, we’ve got to get the kids to start exercising, we’ve got to buy different types of food and more vegetables, and turn off the TV,’ and the husband is like, ‘Not going to happen.’ What do you do?”

Goldman said Kognito has had positive experiences working on apps that help caregivers and non-medical professionals, like training military families to talk to their veteran about PTSD.

Unlike Kognito’s other apps, Change Talk is free and will stay free, even if the company decides to add more situations. Other Kognito apps can be licensed to a physician’s practice or are available on Kognito’s online store. The apps currently available in the store range from $25 to $56 and cover topics like helping educators deal with at-risk children and an app focused on training principals, which was created in partnership with The New Teacher Project, an organization that aims to bring good teachers poor and minority students. The VA has also licensed one of Kognito’s programs.

FDA clears ResolutionMD diagnostic imaging app for all image modalities except mammography

By: Aditi Pai | Apr 8, 2014        

Tags: | |  |

ResolutionMD MobileAlberta, Canada-based Calgary Scientific announced that it received a new FDA clearance for its diagnostic medical imaging software, called ResolutionMD, that enables providers to use the mobile software for all imaging modalities.

A Calgary Scientific spokesman told MobiHealthNews in an email that the newly cleared imaging modalities include computed radiography, digital radiography, radio-fluoroscopy, angiography, ultrasound, nuclear medicine, endoscopy and ophthalmology. The clearance does not include mammography.

The company received an FDA clearance for a similar software system in April 2013, which cleared ResolutionMD for diagnosis on iOS and Android devices. Before the most recent clearance, ResolutionMD was just cleared for computed tomography and magnetic resonance imaging.

The ResolutionMD app helps healthcare providers view images in 3D, collaborate with others, and access more patient information.

“We are excited to deliver this clearance to the institutions that rely on ResolutionMD to improve patient care,” said Pierre Lemire, president and CTO of Calgary Scientific. “This is also an important advancement for all our valued partners including those who deliver custom-branded solutions, as they will be added under the Calgary Scientific registration with the FDA.”

Some Calgary Scientific partners include Siemens, Sprint, Medtronic, Accenture and Airstrip Technologies.

In 2012, Calgary Scientific did a study with the Mayo Clinic at its Phoenix location and found that radiologists using ResolutionMD Mobile versus a traditional PACS workstation were able to access CT scans of stroke victims 24 percent faster. The faster pace saved the hospital an average of 11 minutes per patient.

StartUp Health unveils new class, adds Basis founder as EIR

By: Jonah Comstock | Apr 8, 2014        

Tags: | | | | | | | | | | | | | | | | | |  |

CarePredict’s activity tracker.

Startup Health has announced its newest class of 16 companies at various stages of development. That brings the incubator’s total number of companies to 63, three of which have been acquired, including, most recently, Basis Science, which Intel snapped up. Between them, StartUp companies have raised $130 million, the incubator reported.

StartUp Health also announced that Nadeem Kassam, the original founder of Basis Science, has joined as an entrepreneur in residence. The new position is called “Health Transformer in Residence,” and it will involve mentoring existing startups and helping to scout for additional companies.

“To be surrounded by such an extraordinary network of entrepreneurs and innovators and have an ongoing support infrastructure to navigate challenges has been invaluable. I am honored to coach this amazing group of Healthcare Transformers and help StartUp Health continue to find the next generation of innovators,” Kassam said in a statement.

Here are the 16 companies joining StartUp Health:

Althea Health, founded by Greg Cohen, Manu Kodiyan, and Sanjay Raghu, is developing a software platform for patients with rare or neglected diseases. “Rather than being centered on pharma and healthcare providers, Althea’s business model is patient-centric and aligned with the interests of rare disease groups,” the founders write on their website. They plan to eventually expand the platform to other disease groups.

Fort Lauderdale, Florida-based CarePredict is a startup focused on seniors who want to age independently. Using a wrist-worn activity tracker and journaling software, the system learns the daily patterns and rhythms of seniors so it can notify family or friends when the senior deviates from those patterns. Satish Movva and Krishnatej Vedala are the founders. Keep reading>>

Patients want more services, online outreach from pharma

By: Jonah Comstock | Apr 7, 2014        

Tags: | | | | |  |

accenturePatients want pharmaceutical companies to reach out to them through more digital channels, and to offer more value-add services, according to a new survey from Accenture of 2,000 American adults who are taking one or more medications and have a household income of $25,000 or more.

“Providing personalized and value-add services in support of the products they sell is common across almost every other consumer-facing industry from retail to telecomm, hi-tech and travel,” Accenture writes in the report. “Why should pharma be any different? Especially when addressing something as important as someone’s health?”

Accenture found that those surveyed still most want to receive medication information by mail and email — 66 percent wanted information from their pharma company in printed form and 69 wanted it via email. For pharmacists, 72 percent wanted printed information and 73 percent wanted email. But demand was still reasonably high for mobile and web outreach — for pharma company information, 48 percent wanted to be reached via websites, 44 percent via mobile devices, and 38 percent via social media. For information from pharmacists, 64 percent wanted website outreach and 38 percent wanted an app, but only 15 percent were interested in hearing from their pharmacist on social media.

More generally, 68 percent of patients said they spend several hours a day online, including 69 percent of patients over 65. Eighty percent of patients said they were proactively seeking information about their medications.  Keep reading>>

Scanadu production backed up, but FDA loophole ready to go

By: Brian Dolan | Apr 7, 2014        

Tags: | | | | | | |  |

Black ScanaduOver the weekend Mountain View, California-based Scanadu, a well-financed startup building a suite of smartphone-connected medical diagnostic tools for home use, told its Indiegogo supporters that it would delay shipments of its premier Scout device by as long as two or three months. The company began shipping its first set of devices to its earliest backers last week but in the meantime discovered a handful of issues with the Scout and its manufacturing process.

Scanadu explained the problems to their supporters in an email that read: “There are three fundamental issues that led to this decision: 1. The algorithm that connects the investigational devices with the app is inconsistent in reading scans made with the newly manufactured investigational devices. We have identified the issues in the algorithm and are working feverishly to address them. 2. The temperature readings are faulty, but we are in process of identifying the fixes needed to solve this. 3. Finally, the manufacturing tool used to make the investigational devices broke this week after the first few hundred casings had rolled off the line.”

Delays for shipments of devices from digital health hardware companies that leverage crowdfunding platforms has become routine. Almost no company has managed to deliver on the time frame it promised during its crowdfunding campaign, which makes the Scanadu delay somewhat expected. That said, Scanadu’s co-founder seemed confident last summer that the team would hit its mark.  Keep reading>>