Mobile Heartbeat to Exhibit in Cisco Booths at the 2015 e-Health Conference

Company to demo its smartphone application enabling secure mobile clinical communications and patient-specific workflow in Cisco’s Booths #725 and #824

Mobile Heartbeat today announced it will be exhibiting in the Cisco booths, #725 and #824, at the 2015 e-Health Conference taking place June 1-2, 2015, at the Metro Toronto Convention Centre in Toronto, Canada. The company will be demonstrating MH-CURE® (Clinical Urgent REsponse), its secure smartphone application enabling clinical communications, patient-specific workflow and a real-time clinical team directory connecting all members of a patient’s care team.

What’s an MDDS and why is it important to your mobility strategy?

Over the past few years, there have been many conflicting views on whether smartphone applications require FDA regulation, pre-registration or nothing at all. In July of last year, the FDA published a set of guidelines to clarify their views in light of all the smartphone apps coming to market. To better understand the FDA’s position, let’s walk through the critical points.

Definition of an MDDS
According to the FDA’s web site, a Medical Device Data System (MDDS) is defined as:

Medical Device Data Systems (MDDS) are hardware or software products that transfer, store, convert formats, and display medical device data. An MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device. MDDS are not intended to be used for active patient monitoring.

One of the key aspects of this definition is that the MDDS (which could include smartphone apps that are software products) specifically “does not modify the data.”

What about apps?
So, the next questions are:

  1. Can smartphone apps be considered MDDSs?
  2. If so, how should they be treated?

This is where the FDA’s intentions get a bit more complex. To further clarify, on February 9, 2015, the FDA published a guidance document on Mobile Medical Applications. In this document, the FDA defined the following terms:

  • Mobile Platform
  • Mobile Application (Mobile App)
  • Mobile Medical Application (Mobile Medical App)
  • Regulated Medical Device
  • Mobile Medical App Manufacturer

These definitions were then used to outline where the FDA will focus their regulatory efforts as well as the “mobile apps where the FDA intends to exercise enforcement discretion.” In the FDA’s view, this means that for these mobile apps, “The FDA does not intend to enforce requirements under the FD&C Act.”

This guidance document contains numerous examples of the above-defined terms, however, one of the key examples in your mobility strategy is in Section V- B, “Mobile Apps for which FDA intends to exercise enforcement discretion (meaning that FDA does not intend to enforce requirements under the FD&C Act).”  In item #7 of that section, the FDA lists the following:

Mobile apps that meet the definition of Medical Device Data Systems – These are apps that are intended to transfer, store, convert format, and display medical device data, without controlling or altering the functions or parameters of any connected medical device, as defined in the MDDS classification regulation (21 CFR 880.6310). These mobile apps include those that are used as a secondary display to a regulated medical device when these apps are not intended to provide primary diagnosis, treatment decisions, or to be used in connection with active patient monitoring (i.e., mobile apps that meet the MDDS definition).

In essence, if an app meets the definition of an MDDS (from above), then the FDA does not intend to enforce its requirements on this app. The FDA’s view, which we applaud, is to regulate where appropriate but to not hinder innovation.

Although this latest guidance has the header “Nonbinding Recommendations,” we applaud the FDA’s thinking around innovative mobile apps. With an overriding goal of safe and better patient care, the FDA is taking a very thoughtful position on this rapidly evolving technology.

Mobile Heartbeat to Exhibit at 2015 International MUSE Conference

Mobile Heartbeat today announced it will be exhibiting at the 2015 International MUSE (Medical Users Software Exchange) Conference taking place May 26-29, 2015, in Nashville, Tennessee. The company will be in Booth #1634, showcasing MH-CURE® (Clinical Urgent REsponse), its secure smartphone application enabling clinical communications, patient-specific workflow and a real-time clinical team directory connecting all members of a patient’s care team.

2015 MUSE in Nashville: See the Continuing HIT Evolution

In 1981, about 70 MEDITECH users convened for the first time in Boston to discuss issues related to their HCIS (Healthcare Information System). Two years later, a small group got together and officially formed the MEDITECH Users Software Exchange, otherwise known as MUSE. Today, MUSE has over 3000 members from around the world and is organized entirely by volunteers. The flagship event of this group is the International MUSE conference, which is held every spring, providing a user-driven networking environment with an emphasis on education and learning.

I attended my first international MUSE conference in Scottsdale, AZ in the 90’s and met with about 1100 attendees. At that time, there was a lot of talk about the new “client server” architecture.  Since then, user membership and ancillary application vendors has been growing each year.

My top 10 to-do list when attending MUSE always includes the “Big Event,” which is usually hosted by one of the sponsors and provides a convenient opportunity for informal networking, catching up with old friends and learning how users really benefit or experience frustration with their EHR. This year’s keynote speaker is MEDITECH’s Executive Vice President, Hoda Sayed-Friel, who is responsible for strategic direction. Hoda will be speaking about MEDITECH’s vision and strategy and the driving market forces, such as consumerism, population health, care coordination, and precision medicine. We will also hear about MEDITECH’s latest 6.1 release which features a number of reengineered modules.

A great side benefit of the event being hosted in Nashville this year is the close proximity to HCA’s headquarters and surrounding HCA hospitals. This year’s Hospital Site Visits will be hosted by HCA’s TriStar Southern Hills and TriStar Hendersonville, where visitors will be able to see Mobile Heartbeat’s MH-CURE® live and in action. Another great benefit of being in Nashville is the availability of music and entertainment which I hope to experience.

The most interesting part of MUSE from my perspective is the growth and increased number of exhibitors over the years. This will be the third year in a row that Mobile Heartbeat has exhibited and demonstrated MH-CURE, our smartphone clinical communications solution. With all the secure texting apps on the market, Mobile Heartbeat takes a unique approach in offering HIPAA-compliant secure text messaging as a feature and not the whole solution. Through deep integration with MEDITECH, Mobile Heartbeat provides a feature-rich, clinically designed and enterprise-proven mobility application that is a must-see on every hospital’s 2015 MUSE agenda.

Come see us for a live demo at booth #1634 at MUSE.