by Holly Shoemaker
In a previous blog I recapped how text messaging had become a preferred
method of communication for those working in the emergency room (ER). Now,
some medical professionals have looked at texting as a means of sending
information regarding patient follow ups.
Study at a Glance and HIPAA
A recent study published in the American Journal of Public Health (AJPH)
looked at using text messaging to follow up with lower-income parents whose
children had received a flu shot and needed follow-up visits.
The participants determined they wanted to send targeted messages, which
were to include the child’s name and a reference to a “second flu shot.”
That seemed like an easy and effective way to remind parents about a
follow-up visit, and texting provides an easy way to communicate with a
majority of patients. However, there were problems with the language. The
message contained Patient Health Information (PHI) as defined by the Health
Insurance Portability and Accountability Act (HIPAA). Under HIPAA, all
communication must protect patient information. In this case, the message had
the patient’s name and implied he/she had already received a flu shot. Those
two pieces of information violated patient privacy.
Text messaging is also not considered a secure form of electronic
communication. Even when sent by secured means, there is no way to guarantee
the intended recipient receives the message.
The study team found away to protect PHI. It eliminated names and made the
language generic. Instead of saying that a child needed a second flu shot, the team
send a reminder that some children may need a second one. The message ended by
prompting the recipient to call for an appointment.
Concluding
Thoughts
The study serves as a good reminder for those medical professionals who
prefer texting. It is a feasible means to communicate as long as the messages
keep patient information private. The study also sets a standard on how to
comply with HIPAA and PHI.
Blogs about apps, our app development experiences, and what's new in this industry.
Saturday, February 23, 2013
Thursday, February 21, 2013
Medical Mobile App Clearance Times Decrease
by Holly Shoemaker
The Emergo Group, a medical device consulting firm, has provided updated information that shows the time it takes for apps that undergo the 510(k) process has decreased.
Numbers at a Glance
The study shows that medical mobile apps that undergo the 510(k) process takes about 138 days to receive clearance from the Federal Food and Drug Administration (FDA) in 2011, which was down from 146 days in 2010.
The data analysis took submissions through the end of 2011 to look at a 12-month data set. The analysis showed that 95 to 97 percent of all 510(k) applications received FDA clearance within one year of submission.
What is 510(k)?
The 510(k) status is a pre-market submission made to the FDA to show that a device may be marketed as safe and effective. Introducing a new device or changing the usage are some reasons for needing this clearance. The FDA publishes further guidelines here.
Good News for Developers
One of the hurdles for developers designing medical mobile apps was the time needed for clearance. Any additional delay meant using more time, money and other resources. What the study found was that many medical mobile apps have a shorter wait time for clearance when compared to other devices.
Another study by MobiHealth News found 76 cleared apps in the FDA’s 510(k) database, and the average clearance time was less than the time reported by Emergo Group. This study found the clearance time was 25 days shorter between 1997 and 2012, with an average time of 110 days.
Outstanding Issue
Developers continue to debate what the time for clearance actually means. The FDA’s data defines the dates as when the agency receives the 510(k) application and the official “decision date.” Some developers and companies say the wait for clearance is longer because discussions occur before the actual filing of the application.
While medical mobile apps requiring FDA clearance takes more planning, developers have many tools to assist them. I still recommend using Happtique guidelines to assist, as that app store dedicates itself to just health apps.
Concluding Thoughts
No matter which study patients believe has more validity, both show progress when it comes to medical mobile apps clearance. That is untimely good news for patients too because they gain access to better quality information. Once approved, the device is deemed safe and effective, which helps marketing efforts and branding.
The Emergo Group, a medical device consulting firm, has provided updated information that shows the time it takes for apps that undergo the 510(k) process has decreased.
Numbers at a Glance
The study shows that medical mobile apps that undergo the 510(k) process takes about 138 days to receive clearance from the Federal Food and Drug Administration (FDA) in 2011, which was down from 146 days in 2010.
The data analysis took submissions through the end of 2011 to look at a 12-month data set. The analysis showed that 95 to 97 percent of all 510(k) applications received FDA clearance within one year of submission.
What is 510(k)?
The 510(k) status is a pre-market submission made to the FDA to show that a device may be marketed as safe and effective. Introducing a new device or changing the usage are some reasons for needing this clearance. The FDA publishes further guidelines here.
Good News for Developers
One of the hurdles for developers designing medical mobile apps was the time needed for clearance. Any additional delay meant using more time, money and other resources. What the study found was that many medical mobile apps have a shorter wait time for clearance when compared to other devices.
Another study by MobiHealth News found 76 cleared apps in the FDA’s 510(k) database, and the average clearance time was less than the time reported by Emergo Group. This study found the clearance time was 25 days shorter between 1997 and 2012, with an average time of 110 days.
Outstanding Issue
Developers continue to debate what the time for clearance actually means. The FDA’s data defines the dates as when the agency receives the 510(k) application and the official “decision date.” Some developers and companies say the wait for clearance is longer because discussions occur before the actual filing of the application.
While medical mobile apps requiring FDA clearance takes more planning, developers have many tools to assist them. I still recommend using Happtique guidelines to assist, as that app store dedicates itself to just health apps.
Concluding Thoughts
No matter which study patients believe has more validity, both show progress when it comes to medical mobile apps clearance. That is untimely good news for patients too because they gain access to better quality information. Once approved, the device is deemed safe and effective, which helps marketing efforts and branding.
Saturday, February 9, 2013
Simple Communication Steps to Enhance Patient Awareness
by Holly Shoemaker
While healthcare changes are on the horizon, doctors and medical professionals still face challenges regarding the best ways to keep patients informed. Before deciding on the tool used to communicate information, physicians and medical professionals need to ensure they choose the most appropriate way of communicating with patients.
While healthcare changes are on the horizon, doctors and medical professionals still face challenges regarding the best ways to keep patients informed. Before deciding on the tool used to communicate information, physicians and medical professionals need to ensure they choose the most appropriate way of communicating with patients.
Simple Steps to
Follow
- Make Information Available in Many Ways – Simply put, people learn in different ways. Some are auditory learners, others learn by reading, some are kinesthetic learners and others need a variety of approaches. Doctors should consider these methods when communicating with patients and understand how patients best process information. Verbally mentioning information is not always enough to truly communicate. Providing information in a written form, or along with a visual, reinforces points and helps patient remember information related to their own care or conditions of family members and friends.
- Jargon – While patients need access to healthcare information in multiple forms, verbal communication will remain a primary way to communicate with a doctor. Many medical terms may be out the realm of a lay person’s vocabulary. Doctors should ensure they tailor their speech and communicate in terms that reach all patients.
- A Word Is Not Always Enough – Do not always assume that a patient may take a medical professional at his/her word. Use of current research will reinforce suggestions and may serve as a way to open up further dialog, or make a patient feel they may ask questions to better process information.
Concluding Thoughts
By first ascertaining the ways patients take in information,
doctors and medical professionals may then decide on the proper channels of
communication. The technology itself only becomes effective after the medical
community first learns how patients take in information to stay informed.
Subscribe to:
Posts (Atom)