FDA Mobile Health Application Regulations

Right now there are an estimated 17,000 medical apps in use. By 2015, the FDA expects that 500 million smartphone users around the world will be using some kind of healthcare app.

Those are staggering numbers. It is understandable that the FDA sees the need to assert a degree of regulatory guidance over what the agency calls ‘mobile medical applications,’ and has proposed a set of guidelines to do just that.

Our first solution, AirStrip OB, was cleared by the FDA back in late 2005 and first marketed in 2006. It was also the first FDA-cleared app to be made available in the App Store. In reviewing the proposed guidelines, it appears AirStrip’s compliance activities have blazed a trail for other mobile apps to follow.

We knew from the start that we wanted to work closely with the FDA to ensure a high level of quality compliance, due to the innovative intended use of AirStrip Technologies applications. AirStrip gladly chose to do this at the time and will continue to do so. 

The proposed FDA guidelines mirror the compliance efforts AirStrip Technologies has engaged in since its inception. AirStrip has benefited greatly from committing to rigorous quality compliance. An excellent safety record and growing market share tell the industry that AirStrip’s leadership in this regard is hard-earned and well-deserved.

While all AirStrip applications - including CARDIOLOGY and PATIENT MONITORING - are FDA cleared, many other apps in the marketplace are not.

The FDA is indicating that medical apps that do not adhere to agency standards will fall under increased scrutiny for non-compliance. Those app creators will now be expected to offer a level of documentation that they are likely not used to providing, and this will surely alter the mobile medical app landscape. At the same time, true innovation that shows a commitment to quality compliance in the interests of patient safety should have ample room to flourish.

The FDA is now seeking comments online or in writing. The public comment period ends October 19, 2011. You can find more information about the FDA action here.

Early Findings Following AirStrip Cardiology Deployment at Three Hospital Systems

We know that communication technologies that transmit ECGs directly to a smart phone or mobile device allow rapid viewing of ECGs by experts and can be used to overcome logistical and geographic barriers to care. This approach has been proven to reduce E2B times, reduce mortality, reduce morbidity, reduce cardiac damage following STEMI, and improve clinical outcomes. [1] [2]

We hypothesized that by improving logistics, visual clarity, touch screen manipulation, and more data for analysis, providers may be able to more quickly and accurately interpret ECG findings. We delivered this with AirStrip Cardiology™ and we added simultaneous and comparative access to historical ECGs from hospital ECG management systems and from EMS in the field. We demonstrated this technology in previous blog entries. [3]

Over the past several months, we have successfully deployed this technology at a number of hospitals. At least 50 clinicians, most of them cardiologists, are presently using AirStrip Cardiology in a dozen facilities at three major health systems across the country – and that number is expected to quadruple by mid-July 2011.

The preliminary results show a great deal of promise. Physicians currently using AirStrip Cardiology have already reported that the clear, concise resolution and touch-enabled analytics significantly improved their ability to diagnose specific conditions, fostered more timely decisions, supported more rapid intervention, and afforded them an experience of freedom and workflow efficiency. This feedback is consistent across all users. We will publish our physician surveys in whitepapers and highlight them in future blogs.

We are learning that great things can happen with mobile, digital, enhanced ECG. For example, AirStrip Cardiology hospital clients have reported improved STEMI patient care, including reduced time to intervention and reduced false activation of the cath lab. Preliminary findings by hospitals include:

• A median time of 9 minutes from ECG acquisition to view time by a cardiologist, with a resultant 7 - 15 minute reduction in time to intervention.
• A reduced length of stay of 0.85 days per STEMI case, attributed to earlier intervention. Each STEMI day saved is estimated at $2,500.
• A 4% -5% reduction in false activation of the cardiac cath lab. The savings per false activation prevented is estimated at $7,500.

How? Physicians and program directors are attributing these benefits to the following features:

• Immediate, anytime, anywhere access to ECGs, creating the “un-tethered” cardiologist
• Twentyfold improvement in visual display over paper tracings and pdfs;
• Automated interval & axis deviation measurement and more digital data; 
• Elongated strips, making pattern variability more apparent;
• Access to historical tracings, allowing serial presentation and comparison

We will continue to share lessons learned from the deployment of this mobility solution. We are offering a complimentary webinar series detailing customer results from the use of this technology. We’ll post a link to the registration page in our next blog.

References
[1]  Sanchez-Ross M, Oghlakian G, Maher J, Patel B, Mazza V, Hom D, Dhruva V, Langley D, Palmaro J, Ahmed S, Kaluski E, Klapholz M. The STAT-MI (ST-Segment Analysis Using Wireless Technology in Acute Myocardial Infarction) trial improves outcomes. JACC Cardiovasc Interv. 2011 Feb;4(2):222-7. Patients had significantly shorter D2B times (63 minutes versus 119); lower peak troponin I (39.5 ng/ml vs. 87.6); creatine phosphokinase-MB (126.1  ng/ml vs. 290.3); higher left ventricular ejection fractions (50% vs. 35%); and shorter LOS (3  days vs. 5.5 days).

[2]  Khot UN, Johnson ML, Ramsey C, Khot MB, Todd R, Shaikh SR, Berg WJ. Emergency department physician activation of the catheterization laboratory and immediate transfer to an immediately available catheterization laboratory reduce door-to-balloon time in ST-elevation myocardial infarction. Circulation. 2007 Jul 3;116(1):67-76. Epub 2007 Jun 11.

[3]  http://airstriptech.blogspot.com/2011/04/youll-never-look-at-ecg-same-way-again.html

You’ll Never Look at an ECG the Same Way Again

AirStrip Technologies recently launched a global partnership with GE Healthcare to digitize and mobilize ECGs. At AirStrip Technologies, we feel very strongly about providing meaningful mobility for cardiology care in the form of mobile, enhanced, digital ECGs, which we believe will improve and expedite critical decision making capacity for Cardiologists. I have recorded a short demonstration of the new technology and I am positive that you will never look at an ECG the same way again.

Why? There are 16.8 million people with coronary heart disease, and 14.4 million people with cardiac dysrhythmias in the U.S. More than 10 million people suffer from cardiac-related chest pain [1] and this year, 6 million patients with chest pain will arrive at hospital emergency departments across the nation. 38% of 1.45 million actual heart attack victims will die; [2] more than 225,000 will die within one hour of the onset of symptoms and before ever reaching a hospital. [3]

No matter what the location or level of care, the 2010 International Liaison Committee on Resuscitation (ILCOR) ACS-MI Task Force confirms what we all know - ECGs are essential [4] to the diagnosis and treatment process of Acute Coronary Syndrome (ACS).

Time is of the essence in achieving the desired clinical outcomes and performance measures for these patients. The literature clearly shows that reducing time to intervention reduces morbidity, mortality, and sequelae. Hence, getting an experienced cardiologist involved early is critical in the diagnosis and management of abnormal ECG findings. [5]

Digital technology advancements now support unprecedented visual clarity, touch screen manipulation, enhanced analytics, and the ubiquitous delivery of this vital intelligence - current and historical ECGs - to a provider’s mobile device.

AirStrip Technologies and GE Healthcare recognized the potential of mobile, enhanced ECG delivery, and responded in kind with an FDA-cleared product designed specifically to make a difference. Now that's Meaningful Mobility for Healthcare℠.

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[1] Heart Disease and Stroke Statistics — 2009 Update, American Heart Association

[2] American Heart Association Statistics. http://www.americanheart.org/presenter.jhtml?identifier=3061132

[3] Lloyd-Jones D, Adams RJ, Brown TM, et al. Heart Disease and Stroke Statistics—2010 Update. A Report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2010;121:e1-e170.

[4] Hazinski MF, Nolan JP, Billi JE, Böttiger BW, Bossaert L, de Caen AR, Deakin CD, Drajer S, Eigel B, Hickey RW, Jacobs I, Kleinman ME, Kloeck W, Koster RW, Lim SH, Mancini ME, Montgomery WH, Morley PT, Morrison LJ, Nadkarni VM, O’Connor RE, Okada K, Perlman JM, Sayre MR, Shuster M, Soar J, Sunde K, Travers AH, Wyllie J, Zideman D. Part 1:executive summary: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2010;122(suppl 2):S250 –S275.

[5] Massel, D. Observer Variability in ECG Interpretation for Thrombolysis Eligibility: Experience and Context Matter. Journal of Thrombosis and Thrombolysis 15(3), 131–140, 2003.

Great Things Happen With Meaningful Mobility

The 22nd Annual HIMSS Leadership Survey [1], released at the HIMSS annual conference this week, showed that half of the respondents from 700 hospitals cited difficulty achieving end user acceptance as one of the top three barriers to achieving meaningful use. Providers need IT solutions that fit their clinical workflow realities. IT can have the greatest impact on patient care when it is used to help providers improve clinical and quality outcomes. Mobility is the key to engaging end users, especially physicians, in meaningful use.

This is absolutely working in hundreds of hospitals nationwide who are using mobile technology to deliver data traditionally locked in clinical information systems. When we leverage the secure and ubiquitous delivery benefits afforded by mobile communications to free up the information otherwise stuck in some application or data warehouse, we transcend geographic and logistical barriers to care. This creates a cascade of benefits. Great Things begin to happen.

For example, we know that mobilizing clinical information can optimize patient throughput. No longer must patients wait for hours in the emergency department until a remote physician specialist can provide a consultation. It can happen immediately, in real time. Care is timely and efficient. Patients get better, faster. Patients and families are more satisfied. Providers experience exponential productivity gains. Clinicians are more satisfied. These are clearly Great Things for healthcare systems, healthcare providers, and the public at large.

When we build native applications that transform the data relative to the device, and deliver it as intelligence in visually meaningful ways, we improve clinical decision making at the point of care. Even more Great Things happen. We enhance cognition. We improve diagnostics. We can guide better choices by patients and providers.

When we incorporate evidence-based medicine and knowledge-based prompts with the delivery of critical information, we create an IT solution that not only helps us achieve meaningful use objectives, but one that helps us begin to improve clinical and quality outcomes. Isn't that where we started with this post?

We've learned that successful HIT Leaders who wish to overcome the big barriers to achieving meaningful use are re-examining how they leverage the data - housed in those EMRs, bedside monitors and devices, pharmacy, lab, and other clinical information systems - to improve care. Those who have added a meaningful mobility solution to their strategy are quickly seeing a difference. Mobility can help achieve meaningful use objectives, and all the while it also causes Great Things to happen.

We’ll explore more Great Things afforded by meaningful mobility in the next few weeks.

References:

[1] http://www.himss.org/2011Survey/

The Return on Investment for Mobile Computing in Healthcare

Ah, the age old question, "What's the return on investment?"

Mobile access involves chunking, transforming, and securely delivering visually compelling data from the hospital computing environment to a mobile device using a native application when providers need to make timely diagnosis and treatment decisions - regardless of their physical location. Hence, the benefits of mobile computing are primarily a function of logistics and ubiquity.

The return on investment for meaningful mobile technology in healthcare can and should be measured. There are three areas to consider when evaluating the return on investment for mobile computing. Each mobile solution or application should be expected to have a unique impact in each of these areas.

1. Strategic - How the technology will be used to help achieve greater organizational goals and objectives;
2. Clinical – Anticipated improvements or gains in quality, structure, and process of care delivery capabilities and better patient outcomes;
3. Financial – The cascade of benefits caused by increased workflow efficiency and improved communication, including those from the strategic and clinical impact areas.

 For example, the financial return on investment for our AirStrip OB product was traditionally measured in the reduction of medical malpractice claims exposure and experience stemming from our ability to target 64% of the losses to a typical insurance program. We subsequently learned that it also reduced physician splitter behavior, improved nursing efficiency, enhanced clinician job satisfaction, and improved physician assessment of nurse competency. Furthermore, first-to-market campaigns have influenced hospital market share by impacting patient and community perceptions of care.

Additional benefits our clients are seeing - and seeking – with mobility include:

• Acceleration of meaningful use objectives, in particular those involving physician adoption
• Enhanced performance of core measures, with greater reimbursement potential
• Elimination of geographic barriers to care and infrastructure to support accountable care organization service delivery
• Improved physician and nursing workflow logistics, communication, teamwork, and greater productivity.
• Better patient throughput and improved satisfaction.

We use financial modeling tools and processes to help our clients predict the return on investment for each of our products based upon their specific circumstances. Cost reductions and revenue enhancements should be considered along with other benefits, such as patient safety, which is even more important yet difficult to quantify. We are learning that many evidence-based measures can be useful in analyzing performance before and after mobile technology adoption to confirm and validate (or disprove) the original impact prediction.

No matter how you slice and dice it, "mobile computing done right", something we call "meaningful mobility" can produce a significant return on investment with far-reaching benefits for patients and providers.

Distinguishing Remote Access From Mobile Access

We frequently encounter folks who ask us about remote access via mobile devices. There's an important distinction to be made here. The usage intentions, patterns, and requirements for remote access and mobile access are very different. [1]

The purpose of remote access is to work in your computing environment when you are not on location. An example of remote access would be accessing hospital information systems and applications via a PC or laptop from your office or home. Often, remote solutions involve a VPN connection, a Windows desktop and/or web browser, and perhaps a remote license to allow the user to interact with the applications they are accessing. Mobile access is a different animal. Mobile users want to do specific tasks - check a lab value, view a waveform, see a medication list, check allergy status - while on the go. Providers want the data transformed into accessible, meaningful chunks, they don't want to have to navigate the entire medical record from their Droid in order to make a time sensitive decision. See table 1.

Some organizations have considered using Citrix to provide interpreted or emulated application access or a pdf view of EHR data and clinical information systems via a mobile device. That's like reading the New York Times on your smartphone using the internet browser. You can do it, but it doesn’t really work. Use the native application provided by the publisher. Native applications are built to run on a specific device and operating system.

We also do not recommend accessing any patient monitoring data via a non-native solution, because visual distortion is almost certain when things like medical aspect ratios cannot be controlled. Further, be advised that the FDA is mandated to regulate medical devices, including mHealth applications on cell phones and associated products. [2], [3]

We know that the reasons for and usage of remote and mobile access differ. We have learned that patient safety and provider efficiency are paramount in mobile application delivery. To optimize your provider access strategy, both approaches must be accommodated.

References

[1] Madden, B. 2010. Remote desktop access vs. mobile access: What’s the Difference? http://searchvirtualdesktop.techtarget.com/feature/Remote-desktop-access-vs-mobile-access-Whats-the-difference.

[2] Thompson, B., Kendall, L. 2009. How to Get FDA to Clear a Mobile Health App. http://www.ebglaw.com/showarticle.aspx?Show=12184

[3] Kumar, R. 2010. The FDA’s Regulation of Mobile Technology as Medical Devices. http://www.law.uh.edu/healthlaw/perspectives/2010/kumar-fdamobile.pdf.

Meaningful Mobility for Cardiology Care

A 12-lead ECG is a snapshot in time of 3 spatial views of the heart's electrical activity from 12 angles. It is generated by placing 10 electrodes on various parts of the body including the arms, legs, and chest. With a 12-lead, we are simply taking a multi-dimensional picture of heart conduction from right to left, top to bottom, and front to back.

Once the electrodes are placed, the ECG recorder is run. The recorder digitally captures the multi-dimensional picture. Although the machine will virtually record all 10 seconds of data per lead, all traditional ECG print outs and the current pdfs currently used in most mobility solutions only provide 3 seconds of data for each lead, and those three seconds are printed, static, flat, and non-interactive.

The output of an ECG recorder is a tracing on a graph. Time is represented on the x-axis, and voltage, or amplitude is represented on the y-axis. Look at the following picture describing the time and voltage for a traditional ECG tracing. Notice, for example, how one small 1 mm x 1 mm block represents 40 milliseconds in time and 0.1 millivolts in amplitude? (See Figure 1).

Now let’s look at how mobility providers can add serious value to the ECG equation. One way is to mobilize a pdf version of the ECG tracing. (See Figure 2). Helpful - but where is our data transformation in this equation? Consider it’s time to move to the next generation mobile solution. (Figure 3).

Figure 1

Figure 2

Figure 3

AirStrip Cardiology ™ provides the ability to scroll through a full 10-second ECG for all 12 leads and set any of the leads as the rhythm strip – clinicians choose the beats used for analysis. In addition, the dynamic ECG layout functionality grants full control over how leads are rendered, providing the option to see all 12 or 15 leads for the ECG or selectively, in various comparative layouts and zoom levels.

AirStrip Cardiology can help clinicians detect changes in mV signal as low as .05 mV (0.5 mm). That’s a twentyfold increase in amplitude detection over paper tracings. End users clearly see sub-millimeter variations, as well as being able to visually scan all 12- or 15-leads at once and see any relative deviations.

In terms of playback control, marking the grid with the measurements coming from GE Marquette® 12SL™algorithms, we also allow play modes for the 10 second digital segment to be full, 1/2, 1/4, or 1/8 speed, as desired. Added features such as user-driven lead selection, maintaining relevance across leads with synchronized pinch and zoom, make this exponentially more interactive. Now that’s meaningful mobility.

References:
[1] http://en.wikipedia.org/wiki/File:ECG_Paper_v2.svg
[2] http://en.wikipedia.org/wiki/File:12leadECG.jpg
[3] © 2010. AirStrip Technologies. All rights reserved