Mobile Medical App Regulations – Are They Necessary?

As I mentioned before, the FDA seemed to be moving faster with proposals to regulate medical applications than with the ever-dragging process of creating guidelines for social media in healthcare. Helthcare IT News surveyed 50 of its readers on what they thought of the sudden urgency the FDA addressed the issue of non-regulated mobile apps.

As you can see on the chart below, 46% of respondents thought that regulations are important for different safety reasons. But the rest of the readers, 54% said that too much regulation could be demotivating and problematic for developers. My question is: can one think both of these statements are right? I think you can agree that some sort of regulation is needed so an app doesn’t offer a band aid for a broken arm (excuse me for the simplified example), but it is also important that the developers can still be innovative and creative.

The article also mentions a concern that is not addressed in the survey. Mainly, that regulations are offered for doctors, so they don’t become too reliant on these applications. First of all, what do you call too reliant? Where do you draw the line? A recent study showed that in the United States every 2 in 5 doctors use mobile apps during a visit. Would you consider that too high? And second of all, isn’t it more of a concern that patients become too dependent on these tools? The doctor has a medical degree to help him/her decide what app to use and how. But what about the patient that follows any advice on a mobile device without seeing a doctor?

(Source: Healthcare It News)

Medicine In The Digital Era

With new devices constantly appearing on the market at a new speed, it is safe to say that the digital era has arrived. It also consumed the medical field with physicians enjoying the perks of having mobile access to the enormous amount of knowledge required while practicing medicine. While it was long obvious that mobile applications and devices influenced doctors in a major way, a recent infographic about U.S. hospitals and healthcare professionals included surprising numbers to prove just how much they became an integral part of practices.

According to the data below, more than 2 in 5 physicians go online during a patient’s visit mostly for drug references, new publications, disease associations or to look for a support group for patients. The most convincing fact was the high rate of doctors using consulting applications with 94% of them turning to these for information. The infographic also suggests that other mobile based technologies are welcomed as well. For example 86% of physicians are interested in accessing electronic health records, while 83% of them would like to use these devices as prescription tools.

The data also highlights the fact that more and more doctors go on social sites for professional reasons. At the 1188 hospitals observed Facebook seemed the most popular with 1018 pages created. These healthcare facilities shared overall 548 Youtube channels, 788 Twitter accounts and 458 LinkedIn profiles. One thing that stood out was the relatively low number of hospital blogs with only 137 listed for all 1188 hospitals. Despite the fewer blogs in these organizations, the infographic states that blogs are actually favored by doctors compared to private online physician communities.

The numbers once again show the significance of the “mobile movement” among healthcare professionals. Maybe this magnitude is why the FDA, while usually slow in similar cases, felt the urgency to address this phenomenon with its draft guidance for mobile medical applications.

 

(Source: Spinabifidainfo.com)

“Sticky” Patient Comments On Facebook

The conversation about Facebook’s changing commenting policy has been going on for a while now. In a recent, very detailed overview on Pharmaphorum.com, Wendy Blackburn lists the new risks and the possible solutions for the recent  challenges. And finally there are multiple ways of dealing with this issue surface instead of the regular “keep the comments disabled or turn away from Facebook” answer.

The post also highlights certain situations when patient commenting could turn into a problem. People posting off-label use, positive outcomes, their joy over an unfinished clinical trial, their way of using a different dosage of a drug:

“[Drug X] was FDA-approved for asthma but my Dr. prescribed it for COPD and it worked great!”

“Whenever I self-inject [Drug X] I use ice to make the injection feel better and I also take ibuprofen. You should try that.”

“I’ve learned that if I cut my pill in half, I still feel okay, but my prescription will last longer and costs less.”

In the imaginary comments above, you can read about off-label use, unauthorized medical advice and usage not in sync with the recommended dosage. These could all cause problems for a pharma company. But that doesn’t mean that these comments shouldn’t be made possible. They reflect on real situations and sometimes real problems whether they violate regulations or not. Choosing the right platform for this may be challenging, but it is definitely an urgent and crucial task that needs to be faced.

I do understand that unless it is made clear that a pharma company is not responsible for user comments on a Facebook page, allowing these posts are great risk factors. I do agree that this has to be decided. But why wait on the FDA to declare that? Disclaimers work just fine on blogs, Twitter and different social media platforms. Why wouldn’t they be enough for Facebook comments? For content published by others than the company?

There are also different tools for keeping your Facebook wall under control. The post mentions extensive monitoring, moderation, filtering or creating a branded page. So there are solutions for “sticky” patient comments on Facebook. They are time-consuming and result in a large workload, so companies have to decide carefully if it’s worth it or not. The question that still lingers is: what can we do about the issues, like the examples quoted before that have to be hidden on social platforms? Where are those notions going to be addressed?

For more interesting and exciting posts, check out Pharmaphorum.com!

(Source: Pharma on Facebook: past, present and future)

More Studies On Online Health For Guidelines – Is That Really Necessary?

No one was really surprised about the postponing of the social media guidelines by the FDA. Sometimes I wonder if anyone takes it into consideration anymore. It looks like online healthcare is well and growing without the help of the FDA.

Just a few examples: Roche has a very detailed set of social media rules for its employees, Astra Zeneca uses social media, especially Twitter to reach patients, the Mayo Clinic was one of the first hospitals to give some guidance to its doctors. For them, the ever changing features of social media and internet culture didn’t seem to create any problems.

So what is the reason behind the delay of FDA guidelines? Apparently not enough knowledge. The FDA released a statement late April, saying they would like to furthermore study the connection between the internet and healthcare. It seems like two years and a public meeting in 2009 weren’t enough to collect all the necessary data. With hundreds of articles and studies published about online health, numerous Twitter chats carried out, it’s hard to believe the resources are not satisfactory.

And while healthcare and pharma organizations are not in desperate need of the FDA guidelines, it would be crucial to provide regulations for online health content read by millions of patients.  Because you don’t need to read another study to realize, internet is one of the sources when it comes to medical information.

(Sources: World of DTC Marketing, Eye on FDA)