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Does all Healthcare Apps Need to be HIPAA/HITECH Compliant?

HIPAA has helped the people in preventing their loss of health insurance.Over the years it has reduced the cost overheads as well as the administrative works of healthcare transactions.

Which Apps require HIPAA compliance

If app stores Protected Health Information(PHI) data such as information of the patient to be entered by the doctors or by the patient itself after the health check-up, then it has to be HIPAA compliant.Its compliance applies to both Covered Entities and their Business Associates.

Covered Entities(CE) include insurance companies, clinics, health plans, Doctor’s offices and more.They are anyone who provides treatment and operations in healthcare.Whereas the Business Associates(BA) are the ones who provide applications which manage PHI, this includes app development companies.

Protected Health Information Vs Consumer Health Information

If your app shares patient’s personal health data to any of the covered entities, then it comes in the category of Protected Health Information.Which needs HIPAA compliant.

If your app stores the personal health information which doesn’t need to be required to share with the covered entities, then it deals with the consumer health information. Which doesn’t need HIPAA compliance.

It’s very tricky to identify which falls under the category of PHI. Any information of patient’s health varying from past to present which has been created and maintained by a CE falls under the category of PHI, whereas when such data is collected publicly through surveys or any other modes then it doesn’t fall under the category of PHI.

How to become HIPAA Compliant

In order to meet HIPAA compliance, following requirements must be fulfilled:

  • Patient’s health information must be protected by putting efficient safeguards
  • Limited sharing as well as the use of PHI
  • An Agreement must be there with the Business associates which will ensure that they store, use and disclose the PHI properly, no misuse of such information is permissible.
  • Procedures must be followed which will limit the access of PHI’s and how to safeguard the PHI’s.

Requirements for HIPAA compliance

Your app must ensure that it meets the four main parameters of the HIPAA law.

  • A Person who is going to manage the protected health information must be well trained and guided about the importance of keeping it confidential.
  • The service provider must provide facilities such as assigning a particular name for identifying and tracking the identity, provide facilities for emergency access, automatic termination of sessions after certain amount of unused time, data encryption and decryption facilities, implementing mechanisms to examine the data for audit purposes, immediate alarm raising facility in case of any unauthorized security breach, and proper verification of the persons or other medical experts who are going to use it.

Legal proceedings in case of violation

If you violate any of the guidelines needed for the HIPAA compliance then the penalty can vary from USD 100 to USD 50,000 per violation. The penalties also vary according to the type of violation.The violation penalty can also go up to USD 1.5 million, it’s up to the regulators who are going to review your violation and charge the penalty accordingly.However, during the audit if the regulator finds any flaws in procedures and policies of a company then they will not impose any penalty, rather they will direct the company to follow the corrective actions to improve it.

It’s crucial for Healthcare Application Development Companies who comes in the category of business associates(BA) that they must understand the purpose of the app, which people are going to use it, what type of information is to be stored, collected and shared, whether the doctor or the patient will be entering the information etc.The healthcare app must be developed by keeping in mind all this as well as its compliance towards HIPAA laws.

Last modified: 31 Aug 2018