Ingestible Sensor technology--Wearable, on the Inside

First Medical Device Cleared by FDA With Adherence Claim

Patient ingests medication by mouth

Wireless Receiver Applied to arm or abdomen, transmits signal to Smart Device

or other monitor

How Does the Pill Work ?

Micro-chip embedded in Pill

Proteus Digital Health, Inc. today announced that the FDA has expanded the Indications for Use statement for the latest generation of its Ingestible Sensor technology, enabling the device to be used as an aid in the measurement of medication adherence. To the Company’s knowledge, this is the only device with an FDA-sanctioned claim for measuring medication adherence.

“We are delighted that our collaborative work with the FDA continues to enable positive progress”

An estimated 50% of us do not take our medicines as prescribed, potentially limiting the therapeutic effectiveness of our medicine and resulting in $100-300 billion in avoidable healthcare costs in the US alone due to unnecessary escalation of treatment.1 There have been many efforts to address this challenge but no products have previously been cleared by the FDA for aiding in the measurement of adherence until now.

“We are delighted that our collaborative work with the FDA continues to enable positive progress,” said Proteus Co-Founder and Chief Medical Officer Dr. George Savage. “We believe that ingestible devices have the potential to speed clinical trials and improve the real-world effectiveness of medicines in community settings.”

When used with a medication, the Proteus Ingestible Sensor marks actual intake time, a quantifiable event that has allowed regulators to grant the expanded indication to the company. The Ingestible Sensor was approved by the FDA in 2012 and communicates with an adhesive patch, worn on the torso. The Proteus Patch records time of ingestion along with steps, rest and heart rate, and communicates to a mobile app via Bluetooth.

As many players enter the wearables space, Proteus Digital Health is leading a new ingestible category in order to derive unprecedented insights about medication-taking behavior and physiologic response to therapy. Proteus is the only company that combines ingestible, wearable, mobile and cloud computing.

About Proteus Digital Health®

Proteus is creating a new category of therapy: Digital Medicines. Digital Medicine therapy includes drugs that communicate when they’ve been taken, wearable sensors that capture physiologic response, applications that support patient self-care and physician decision making, and data analytics to serve the needs of doctors and health systems. The goal of Digital Medicines is to empower patients and their families, enable physicians and health systems to more effectively manage risk and ensure that outcomes are reliably achieved.

Proteus received FDA market clearance in the United States and a CE mark in Europe for its wearable and Ingestible Sensor devices. 

A Review of the midyear progress of mHealth

A Review of the midyear progress of mHealth focuses on several mHealth IPOs,  specifically Fitbit and Teladoc.

They serve two separate niches, fitbit in the area of mhealth wearables, and Teladoc as a provider-patient centered application allowing remote video patient encounters with physicians.

Several transformative shifts are occuring between mHealth and EHR integration. In some cases mHealth is driving EHR integration.

Our blog today offers a quick centralized source for progress in mHealth application development.

Will mHealth's rise signal the end of the EMR?

One of the hot trends is the integration of patient-facing data into the electronic medical record. 

EPIC , is developing it's own mhealth application in concert with Apple's Healthkit. Epic has begun to offer details about what the platform will look like when the kinks are finally ironed out. 

From Epic's new app store to Validic's partnerships with Cerner and athenahealth (to name just a few), EMR platforms are evolving to accept health and wellness data from devices to better define a patient's profile outside the medical encounter.  "It's not just physician documentation any more," says Girish Navani of eClinicalWorks. "The patient is part of that equation … but there have to be filters."  Consumers, she says, "are more involved in their healthcare, which puts the onus on (clinicians) to work with them, but we haven't seen much good data come out of the FitBits and other consumer-facing devices" that would make a doctor sit up and take notice.

 EHRs and wearables - their time has come?]

The convergence of two industry titans, Apple and Epic portends another swift sea-change fueled by adequate capitalization of IPOs and equity funding. Does this mean the EMR is becoming obsolete? Or is it evolving into an EHR?

Much of the conversation between a doctor and a patient focuses on what the patient is doing outside of the doctor's office – in other words, the doctor is looking for data that today's health and fitness wearables are collecting. This means that all that information in the margins is now being pulled into the record.

Providers say they don't want all that extra information coming into the medical record, but they can't deny the value of health and wellness data in developing a care management plan for their patients. They're worried about validity – is data entered by the patient reliable enough to be included in clinical decision support?

At this point, the answer is no, and mHealth vendors and EMR providers understand this. As Navani points out, the data has to be curated first – collected, sifted and organized into something that a provider can trust and ultimately use. Some EMR companies tackle this issue by shunting consumer-entered data into a PHR or similar silo; the consumer then grants permission to the provider to parse over that data and determine what can be pulled out and ultimately entered into the medical record.

f that's the case, then this truly is a health record, not a medical record.

The proliferation of consumer-facing apps and devices has also given rise to a dichotomy in how mHealth data is collected. On one side stand platforms like Apple's HealthKit and ResearchKit, which gather consumer data for use by healthcare providers. On the other side are platforms like Qualcomm Life's 2net hub, which takes data from reliable devices – not the consumer – and goes to great lengths to ensure that such data is "medical grade."

Can both data streams share space in the same record? That depends on how EMRs and EHRs are defined.

EHRs and Medical Students: How to educate Medical Students

Practicing medicine today means interacting not just with patients, but also with computers. As of 2013, nearly 80% of office-based physicians were using electronic health records. But medical schools have been slow to keep up with the trend. There's no national standard yet for how med students should be trained on EHRs. Some are using computer systems from day one of their education. While others may be forced to sink or swim once they start to practice. This is a report for iHealthBeat, a daily news service of the California HealthCare Foundation.

<Audio Transcript>

I'm Ali Budner Priyanka Chilakamarri is a fourth-year medical student at the University of Vermont. From very early on, she and her fellow students were expected to engage with their lessons through computer screens. (Chilakamarri): "When I first started medical school ... they gave all the students laptops." They also immediately started using computers in their interactions with patients. That meant learning how to use an EHR system. But EHRs are complex and notoriously hard to teach. (Jemison): "Because inevitably the computers are attached to walls, your back is to a patient, there's a lot of physical reconfiguring you have to do in order to take notes." Jill Jemison is the director of technology services at UVM, Chilakamarri's school. (Jemison): "We're teaching them how to do a good note, how to put all the information in it, how to collect the right thing." The third year of med school is when students would typically be exposed to EHRs, when they start clinical rotations. But in her very first year at UVM, Chilakamarri was already practicing on what's called a "dummy EHR," a system that's been stripped of identifying personal information to protect patient privacy.

Comments:

Harold Lehmann

Consider constructing a curriculum around a virtual (or multiple virtual patients). Cases should be created in the training environment, not only for the purpose of training in the use of the EHR per se, but also for teaching how to practice medicine in this machine-centric environment. Hopefully, one can teach how to be efficient, yes, but also, how to *think* in multiple screens that are not designed necessarily to aid cognition.

June 18, 2015 at 2:38 PM

Lauren La Barge

Many of my friends and colleagues are medical students, and I was fortunate to live with many medical students at a top ranked institution. They are interested in curious about EHRs generally, but lose interest as they are unable to interact with them. Suddenly when they are in a clinical setting using EHRs for the first time, there is a lot of frustration and confusion. My friend, a first year anesthesia resident, used to take hours of work home on Epic! Teaching EHR use in the medical curriculum needs to be a part of the medical school experience.

June 18, 2015 at 10:44 AM

Michael Warner

Medical students are in a tough position today as they are hands-off when it comes to the EHR. I was not allowed to write in the chart either, when I was a nurse's aid. I realize the legal ramifications, but patients are now able to view their records on patient portals and enter information. Why not allow the student doctor to partner with the patients and construct the History component of the encounter note? In research study that just concluded, patients where able to "co-author" their health record by writing a Pre-History. Imagine if medical student partnered with a patient to document her or her story? This might lead to a future where patients and providers get closer - while using the EHR as a tool.

July 2, 2015

Gary Levin M.D.

The clinical practice of medicine is changing rapidly. Advances in basic and clinical science challenge praactitioners as well as neophyte trainees. Today a new curriculum is developing in medical school focused on health information technology. Electronc health records and eRX are just two of the niches.

Today pre- medical students have a computer, pc tablet or are given one when they enter medical school. Much of the curriculum and even examinations are offered via this tool. Medical students enter school with considerable exposure to computer technology and operating systems.  They are facile with the hardware.  This is not so for EHR software.

Some thought is being given to  training students to use EHRs. However hospitals, and clinics may use different EHRs, and training students to use one does not necessarily translate to using another one.  In fact studies have shown it is easier to teach a student an  EHR if they have never used one.  Changing EHRs requires unlearning the original EHR to use the new EHR.

In general it may be more important to teach  adaptive skills, such as where to place a computer monitor or keyboard to minimize visual isolation from a patient. Digital health space believes that tablet PCs are the most user-friendly in the clinical environment.  It can be used much like a classical paper progress note... The addition of touch screen functionality is even more useful.

E-value Mobile Health Education Curriculum Accreditation Management Clinical CompetencyCl

For those of you who have, or are discovering the  wealth of health apps available, not just for EHR or patient care we are publishing this special edition of Digital Health Space.

The title covers a swath of applications which may be unknown to  conventional practitioners and even some academicians.

1. E-value
2. Mobile Health
3. Health Education
4. Curriculum
5. Accreditation Management
6. Clinical competency logging

E*VALUE is a cloud based service (SAAS), which offers multiple solutions for users as needed.



Optimized Scheduling

Clinical Solutions

Teaching Solutions

Accreditation Solutions

     NAS & Milestones

     GME Insight

   Features of GME Insight Include: 

• Milestones Reporting
• Specialty-specific and sub-competency content
• NAS-Related Program Indicators
• Program-Level Dashboards and GME-Level Dashboards
• Support for Annual webADS Reporting
• Secure Data
• PubMed Interface
  Allows students, faculty and administrators to retrieve, review and save PubMed articles without leaving E*Value.
• Accessible From Any Device With Internet Access

    Teaching Solutions  (Video)

Empowering the Patient

New business models for pharmaceutical and medical device companies

Mobility is a key factor for staying in the game. This applies to providers as well.

How interoperability impacts the pace of mHealth adoption

Intelligent healthcare and the power of mHealth (Video)



Patients, health insurers, pharmaceutical companies, medical device manufacturers, hospitals are all adopting to the new 'mobile health paradigm.  Providers seem to be the last group to sign on