How safe is that health app? A Q&A with Happtique (Part II)

Today, I discuss who is responsible for keeping health apps from harming you, in Part II of my Q&A with Paul Nerger, Senior Technology Advisor for the mobile health application management company Happtique. (Part I explained who uses and develops health apps).

How are health apps regulated to ensure that they are safe and accurate (both stand-alone apps and those that connect to a medical device)?

There are guidelines that have been proposed by the Food and Drug Administration (FDA) for the approval of some apps; we estimate that this will be no more than 20% of the apps that are out there. These will be classified as Type I (non-invasive), Type II (semi-invasive), and Type III (invasive), and each has its own approval criteria. Type I is a self registration while the other categories require clinical trials to prove that they do no harm and are effective. [Information about how the FDA defines mobile medical applications is available online.]

But what about the other 80%? That is what our customers have been asking us. If there is a bogus app within this category, the Federal Trade Commission (FTC) has shown that they are willing to exercise their power to have it pulled off the market using "false advertising" as the rationale. [Mashable includes a health app in a list of app developers that the FTC prosecuted in 2011]. But this is also a very small percentage.

In response to this, we've come up with a Blue Ribbon Panel that is made up of a leading physician, a leading nurse, a leading medical technologist, and a leading patient advocate to develop a protocol for the certification of apps as being medically sound within their category. They are currently drafting the process and protocols that will be followed to do this certification. Once they are done, we will put in place a mechanism to allow developers to upload their apps for certification and to receive feedback on what they can do to improve their apps to meet the criteria. Once an app is certified, they will be granted a license to use a "trust mark" for the promotion of their apps. This mark will signal to both clinicians as well as patients that this app is safe and sound.

This is a big job but it is one that needs to be done and we are in hopes of having something out in about 4 months. 

 

How secure is the digital medical information collected via health apps? What security measures protect this digital medical information?

Private health information that is shared with your physician or any other healthcare provider is covered under the privacy aspects of the Healthcare Insurance Portability and Accountability Act (HIPAA). There are a number of technical requirements that an app developer must ensure if they fall within the HIPAA domain. As part of our certification process, we will examine how the app functions, and if it falls within the HIPAA privacy requirements we will assess if the app complies with those technical needs. If an app developer falls under HIPPA privacy but fails to meet the requirement, we will notify them and explain it to them.

Can you explain the process that Happtique will use to rate different health apps?

We are not going to rate apps but rather certify them. In our app stores that we make available to hospitals, clinicians, and patients, we will allow them to rate and comment on apps, but the certification process is independent of that. Thus, when we discover an app (either because it is sent to us or we find it in one of the public app stores) we will first classify it by placing it in the right categories to allow our end users to find it. They will then rate the apps based upon their experience and we will segment those rating based upon what type of audience that they make up. Finally, for those developers who want to be certified, we will make that available for a fee and they will need to provide us with access to their app.

We are doing curation right now and it is available to clinicians who sign up at our website at www.happtique.com. The ratings engine is also turned on and anyone with our catalog app running on their devices can start rating apps.

When your doctor prescribes an app: A Q&A with Happtique (Part I)

If you have a smartphone or a tablet computer, your AngryBirds app might have some new company soon: apps prescribed by your doctor to help you manage your health. Last month, I heard Paul Nerger, the Senior Technology Advisor for the mobile application management company Happtique, talk about the brave new world of health apps at a mobile health panel (hosted in part by the German American Business Association). Intrigued, I asked him to answer some questions about health apps for this blog. 

This is the first post of a two-part Q&A about health apps and how they will impact health care. This post explains who uses and develops health apps. Part II, to be posted next week, explores how health apps are regulated, certified, and rated. 

 

Who uses health apps for smartphones the most: health care providers or consumers/patients? Which group do you think will be driving demand for health apps in the future?

Both.  

Clinicians use professional apps that make their jobs easier. That could be anything from keeping up-to-date on the latest medical journals, using a medical calculator, connecting with a colleague on advice, using the EHR system in the hospital, to looking up the bus schedule to figure out how to get from one facility to another.  

Patients use apps to make their lives better and more healthy. It could be a diet app, or asking questions about their health, or for those on the leading edge, tracking their own medical records.

The really interesting aspect is what happens in the future. In the near future, these two communities will start to interact with each other in ways that we've not seen before. Clinicians will start to "prescribe" apps to their patients and patients will like this because patients (i.e., all of us) trust their physicians and other healthcare professionals who look after us. With over 30,000+ apps available to help us manage some aspect of our health and well being, we will want help in figuring out what is good and what is bad, and our physicians and other clinicians (e.g., pharmacists, nurses, dietitians) will be in the perfect spot to help us.

But the clinicians need help also: they need to be able to discover an app that helps with our particular clinical condition, they need to be confident that the community within their particular professional association is confident that an app is clinically sound, and they need an easy mechanism to prescribe this to any given patient.

These are the problems and challenges that we've given a lot of thought to and are building at Happtique. 

 

What are the most popular health apps currently available?

There are two major categories of apps out there: medical and healthcare. The medical category is really for professionals. Apps such as Epocrates, Skyscape, 5MinuteConsult, Calculate by QXMD, MedPage Today and others are very popular with this community since they are needed by all clinicians. That does not mean that there are not some fantastic apps that are designed to solve a particular problem. For example, you might be a pediatric oncologist and you want an app to run on your iPad to help with informed consent--there is probably an app for that. Thus, the most popular medical apps might be the ones that fit a particular clinician's needs best.

And the same is true for the health apps. The most popular app for an MS patient will be very different than the most popular app for a type 2 diabetes patient.  

In other words, the quest for the "killer app" is the wrong way to look at it. Each of us, be we clinician or patient, will have our own basket of apps that makes our mobile phone or tablet right for us. Thus it is a world of choice and choosing the collection of apps that fit our need.

Again, this is why we at Happtique curate all of the medical and healthcare apps under the sun. It is important that we enable you and your physician to choose the right basket of apps to fit your needs.

 

Who develops health apps, and what is their motivation to develop an app?

I've seen apps built by physicians who want to make it easier for the patients that they treat to receive treatment. I've seen apps built by students who encounter a fellow student or teacher that they want to help make their life easier with a particular app. I've seen medical professionals working with engineers who see particular problems in the hospital that they want to solve and thus they build an app. I've seen leading clinicians who simply want to improve the outcomes of their class of patients. I've seen professional developers who see a market to serve and want to build a business.

In medical and healthcare, there are lots of developers coming from different backgrounds who are developing apps, but the common thread is a heartfelt desire to improve the quality of care, the quality of life, while lowering the cost of healthcare for patients. And this is why mHealth [mobile health] is different than other segments. mHealth deals with the stuff which our lives are made of and thus it is a noble cause regardless of the place that you come from.

Improving CT Scans, Treating MS: Notes from an IR Conference

I am slightly obsessed with the topic of radiation exposure, since I have covered radiation overdoses from CT scans on this blog and written about radiation issues in post-earthquake Japan and treating radiation injuries for Medscape. So I was interested to learn about efforts to decrease radiation exposure in patients when I stopped by the Society of Interventional Radiology's annual meeting in San Francisco last week.

Interventional radiologists (IRs) perform many minimally-invasive procedures, such as placing stents in arteries to increase blood flow or delivering targeted chemotherapy to a tumor. These procedures can often replace more invasive and riskier open surgeries. But the flip side of this medical progress is that some of the imaging technologies used to guide these procedures, specifically CT scans and X-rays, expose patients to ionizing radiation, the type of radiation that can harm DNA. 

A poster at the session explained that CT scans are a key source of radiation exposure in the U.S. This exposure can be decreased by adjusting the CT scanner and basing the dose on the patient's BMI, explained author J. Collins et al. ("A Practical Guide to CT Dosimetry for the Interventional Radiologist").

Another intriguing development covered at the conference: the use of angioplasty (widening a narrowed blood vessel) to treat multiple sclerosis. Angioplasty can clear blockages in veins that might contribute to MS symptoms. Some patients who were studied reported that their symptoms improved after the procedure. The course of MS can be so fickle, though, that it's hard to tell whether symptoms improved or the disease simply relapsed for a while, reporter Laird Harrison explained in a WebMD article on the topic ("Treating Clogged Veins Improves MS, Study Says"). The press release about the procedure from the Society of Interventional Radiology is available online.