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The HIPAA law dictates the information that health apps must collect and how that information is protected. It also establishes the rules for what the company managing your information must do with that information. Most of the essentials fall under the Data Security and privacy section, but personal health data is also covered.
While HIPAA primarily focuses on medical devices, the regulations give other companies, such as online pharmacies, a set of dos and don'ts to follow. Although privacy regulations regarding medical devices have no mention in HIPAA regulations, developers should not overlook their relevance.
The following walkthrough will lead you to a clear understanding of the critical questions explored in this article.
HIPAA Amendments and Changes in Rules
Launching a healthcare app can require significant resources, both from a technical standpoint and staffing resources and the government. Even if you get your app approved by the platform (i.e., app store), you still need to have a setup to ensure that you meet additional regulations. Between July 21, 2016, HIPAA amendment, and January 29, 2017, the healthcare apps for Google Play and the Apple App Store required apps to launch and serve users with the latest version of their app.
With the January 29, 2017, announcement of COVID-19, there have been several changes in the compliance rules. Many healthcare providers were required to submit their app to the app store during the first week of December to continue serving users with the latest version of their app. As you can guess, the only way that most healthcare apps comply with the new requirements is if they have an app submission implemented via the app stores that meet the app store's requirements.
The Privacy Rule
The Privacy Rule was the first significant update to the privacy law in several years, as it separated personal health data from sensitive or traditional business information, such as Gmail. The significant changes include:
- Limits the amount of personal health data that a healthcare app may request from a user.
- Limits how much personal health information a user may be exposed to during processing.
- Requires notifying a healthcare app when while uploading a user's biometric information to the app.
- Allows a healthcare app to ask for an opt-out if the user does not provide any biometric information.
- Allows a healthcare app to set the privacy level of information it remains within.
- Allows a healthcare app to prorate certain charges.
- Allows health apps to provide specialized payment options.
Impact of Privacy Rule on Developers and Development Process
As quickly as app developers can be using HIPAA to develop these apps, they can also be affected. A healthcare app may run into significant problems stemming from the Privacy Rule's restrictions outside medical devices. The amount of personal health information a user is willing to share is a significant concern. Before the Privacy Rule, the only way was to provide permission through a mobile web request. It also means that the server inevitably would receive all this information, so when someone makes a health app request, it will store it indefinitely.
What are the different security needs that you must satisfy to keep data secure? For this, developers need to consider several pertinent elements:
- The technology framework can impact the accessibility under which the patient or user loads a particular application. Accessibility factors related to security include technological flexibility, information layout and format, and media or multimedia content supported for interactive or navigational play.
- The intended user interface of the application.
- Information content of the application.
- Data presentation of the application or content of the application.
- Internal or external security
Steps to Develop a HIPAA Compliant Mobile App
HIPAA protects health information by defining specific minimum data security requirements in the development process of health care apps. Any developer who needs to put his or her app into production should adhere to these commonly found guidelines. This regulated activity ensures the data of a patient's vital health information remain protected.
Every user's data following a data breach is a health and safety risk. The HIPAA mandates the entities to follow these regulations strictly:
Ensure that your app/website contains an emergency call-to-action that will allow users to access and communicate with you during their emergency — even if they don't have their usual phone. Ensure that your app automatically adds any user-generated content published on your website. The content does not require an understanding or interaction from the user for it to be incorporated.
Make sure that your app can upload and download data without compromising the security or integrity of your data. It is also wiser to ensure that your app always uses HTTPS for its communications with the server and that it only accesses secured HTTP resources through an HTTPS connection. Without explicit user consent, there is no access to hidden media. Hiding any content —images, video, or audio — is associated explicitly with full user consent and can amount to an EOI.
Migrating the existing website platform in-house is the first and foremost HIPAA risk. Its risk deepens significantly if a healthcare practitioner uses a website platform like WordPress, Manta, Joomla, or WordPress developed by a third-party vendor, which the healthcare practitioner still uses.
Additionally, suppose your healthcare practitioner is already using or developing apps. In that case, review your options for developing an app and conduct an in-person interview with the healthcare practitioner to understand how it might be useful to them. Depending on the platform the healthcare practitioner is currently using, you may have access to this type of data within your HIPAA compliance process.
If this information is not available, consider connecting with 3rd parties who can submit this type of data (through an API or 3rd party contractor).
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3. Identify App Packages and Maximum Insertions
The first step is to determine the minimum functionality of an app, i.e., the minimum amount of data that the developer will supply. This can be determined based on the type of app — whether it functions as a primary contact lab, or as a commercial medical solution, for example.
A detailed analysis of the sheer size of the app is an indicator of the potential for potential data issues. Hiring or outsourcing health app developers makes sure that the development process meets all the minimum technical requirements. Otherwise, it can lead to a prolonged app's lifecycle. In addition, there must be no excessive bulk data; for some existing apps, there might be 5 x times or more the necessary data.
4. Evidentiary Considerations
The express objective of a HIPAA app is to create a productive healthcare workflow. To that end, safety must be a foundational factor for all the actions contained within the app. The apps need to store data in an aggregated manner first. The underlying app should have the capability to encapsulate the things like data feed from online providers.
Data storage must not be in a way that would leave gaps in time, such as a week, if acquired from third-party data sources. Lastly, a particular emphasis must be placed on encryption — HIPAA does not impose any requirements on the use of encryption technology for apps. It means the encryption technology must be securely stored, protected, and centrally located.
5. Evaluate the Root CA
Finally, it's vital to vet the development team's infrastructure to uphold this critical security measure. For instance, there could potentially exist any underground connection to the actual app owner, or it could simply be the case that a single person can build a rogue server to store sensitive data
It would be very wise to check with the development team about this possibility. Reducing the likelihood of unauthorized third parties building a rogue CA infrastructure for storing healthcare data is possible by implementing enterprise security solutions that help anticipate and prevent unauthorized access to data stored on AWS.
6. Data Storage
Storage of data within the app is one of the most critical steps. Blocked ports, wireless setups, or handwritten contents of the app itself will not help prevent unauthorized access to sensitive data. Storage of data must be in an encrypted, centralized location with a fall-back option.
Partnering With Third Rock Techkno for Developing HIPAA Compliant Apps
As you develop a HIPAA-compliant app that meets these high standards, keep in mind that the quicker the app is to download and use, the better. Suppose your healthcare IT or software provider has a data integration partner who supplies HIPAA-compliant products or a HIPAA-compliant BSD. You must develop and adhere to a HIPAA-compliant program. As you progress through the development of your HIPAA compliance program, consider the following areas of paramount concern when designing a HIPAA-compliant program:
- Data security and backup protocols
- Credentials management and security as it relates to sensitive data
- Evaluating a potential program
- Prioritizing risk mitigation
As your app development partner, Third Rock Techkno understands that risk mitigation includes a formal validation process. It carries the potential to identify, evaluate and remove any knowledge of known or unknown vulnerabilities to the platform before release online. Many organizations use a security scan to validate their platform and verify that no known security vulnerabilities exist. The subsequent steps are to visually inspect physical and digital assets and test them for known and uncovered data security vulnerabilities.