Quite a few healthcare apps do not know whether they really need to be HIPAA compliant. As a matter of fact, HIPAA compliance is required for most medical apps. These applications, as you can guess, contain highly confidential health information. As such, the various rules of ‘HIPAA healthcare app development’ will also almost inevitably be applicable on the different business associates (who are part of the healthcare sector) along with many ‘covered entities. `
In a nutshell, if you are a typical healthcare service provider (or health care service providing facility) such as a clinical psychologist, a doctor, a clinic, or for that matter, even an insurance company, then you will be classified as a ‘covered entity’. Alternatively, if you are also a business that is developing its very own healthcare app or even any other sort of technology platform, then the odds are that you will be classified as a business associate. However, before being in a position to even understand HIPAA and its applications, it is vital to understand precisely what the hype is all about.
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# What exactly is HIPAA?
Broadly defined, there are two important laws that help to effectively regulate many, if not most of the more critical data related security needs for the medical sector: One is HIPAA which stands for “the Health Insurance Portability Accountability Act” and the other one is HITECH or “Health Information Technology for Economic and Clinical Health).” HITECH is more of a recent addition or rather an ‘addendum’ to HIPAA. It serves to add multiple fines as well as penalties for all health-related apps that are not in compliance with either of these two laws, (but more specifically HIPAA).
In general, if an app is deemed to be fully compliant with HIPAA, then the odds are that it will almost inevitably end up being fully compliant with various HITECH rules and regulations as well.
# HIPAA: A history
HIPAA is quite often taken to be the more significant set of rules and laws of the two, partly due to the fact that it had actually been introduced way back in the mid-1990s.
Both the tech and the medical industry (along with all of their respective professionals) had already had a chance to work extensively under HIPAA for a couple of decades. They have been able to better understand all of its implications. However, the world of the 90s is a far cry from the cutting edge technology of today’s communication sector where 4G technologies are now coupled with various smartphones and the rapid development of mobile apps.
The rapid advancements in this field have thrown a lot of challenges for the as yet nascent and emerging domain of the field of medical app development. It is now possible to do today, what was not even possible in the realm of science fiction before.
# Different types of apps that need to be HIPAA compliant
This is where both HIPAA and HITECH come into their own. It is important to understand precisely ‘which’ criteria will dictate whether any particular medical related app actually falls under the jurisdiction of various HIPAA regulations or not. It is imperative that the developers should know this beforehand – that is even before the app is in the process of being developed.
For example, there are many medical apps that will allow their users to be able to share their personal information with their doctors, courtesy telehealth company, health and fitness related platforms, such as Google Fit and Health Kit, to quote a few. It is imperative that such apps needs must be in full compliance with any and all of these HIPAA regulations.
The different fitness apps such as basic running and fitness trackers (for instance), do not need to be in compliance with HIPAA directives. In other words, we can say that should an app be designed more to store information instead of sharing it, then HIPAA rules will not be applicable to it at all. Let us elucidate this concept a bit further to be in a better position to understand exactly which medical apps will need to be in compliance with HIPAA’s various rules and regulations:
There are three major criteria that will define whether an app needs to be regulated by HIPAA. They include the following criteria:
- The nature and type of entity that will be able to use this app
- The nature and type of data that the app either generates or stores or shares
- The nature and type of software (irrespective of the fact that it is encrypted or not) that helps to power the app
These can be subdivided into the following:
1) Entity: That is the person who will be using the App
If an app has been developed for the purpose of being used by any covered entity, such as a hospital, physician, or even a health plan for that matter, it will quite likely need to be in full compliance with all of the HIPAA regulations.
2) Data: the information being used or transmitted or transferred
HIPAA is more primarily interested in what is often euphemistically referred to as ‘Protected Health Information’ or PHI for short. This is the information that forms part of the medical record that will be used in the long run, to help identify an individual as well as the data that had been created or used or even disclosed while providing health care services, such as a diagnosis and/or treatment.
3) Overall security of the software used in the app
This last criterion determines whether any particular medical app actually falls under HIPAA or for that matter, is directly related to any technology that has been employed in its development and subsequent operation.