What You Need to Know About HIPAA Compliant App Development
App Development in the healthcare field is often tricky. In addition to the standard rules, healthcare app developers also have to deal with federal compliance and meet HITECH and HIPAA regulations. This article will focus on HIPAA compliance and its role in protecting private health information.
If you've been developing healthcare apps, you know that you risk heavy fines if you don't comply with HIPAA rules. These fines are imposed according to your level of perceived negligence and can range from hundreds to thousands of dollars per violation. The maximum annual penalty for each violation is $1.5 million, which is often enough to take you out of business.
HIPAA rules are put in place to protect app users from privacy breaches. Over the past few years, the demand for healthcare information on dark websites has risen, resulting in hundreds of data breaches. In 2020 alone, over 18.7 million records were exposed, making it the 3rd worst year in terms of breached healthcare records. As a software developer, how do you ensure that you create HIPAA-compliant healthcare apps?
Here’s everything you need to know about HIPAA compliance for health and wellness application development companies!
A Quick Overview of Descriptions That You Need to Know
Before we get started, here are 3 acts you need to get acquainted with:
- HIPAA: This stands for The Health Insurance Portability and Accountability Act. HIPAA rules regulate how you engage with any patient data that you acquire as you develop the app.
- HITECH: This is the Health Information Technology for Economic and Clinical Health act. It was initially introduced to enhance the adoption of health IT tools, specifically, electronic health records (EHRs). It also eliminates loopholes in the HIPAA act and ensures business associates such as app developers also comply with the set rules.
- SOC 2: this compliance standard was developed by AIPCA (American Institute of CPAs) and regulates how you should manage customer data.
All three acts have one thing in common; they’re mainly aimed at protecting medical records and patient data.
How to Develop HIPAA Compliant Healthcare Application
HIPAA (The Health Insurance Portability and Accountability Act) is a federal law that was enacted in 1996 with the main aim of protecting patient privacy. It highlights and establishes a series of regulatory standards that restrict how healthcare professionals, third-party software providers, or organizations with access to patient data in the healthcare industry can use or disclose sensitive health information. Simply put, it's a law that protects patients by ensuring their data doesn't get into the wrong hands or is used with malicious intent.
The Office for Civil Rights (OCR) is tasked with enforcing HIPAA compliance, while the Department of Health and Human Services (HHS) regulates it. When it comes to compliance enforcement, the OCR mainly investigates the common violations and offers regular guidance on matters that impact healthcare.
A Quick Overview of Protected Health Information
PHI or protected health information includes any details that can be used to pinpoint clients or patients of an entity that’s bound by HIPAA rules. The most common examples of protected health information include:
- Social Security numbers
- Phone numbers
- Financial information
- Medical records
- Full facial photos.
The other HIPAA regulations that you need to understand include:
- Availability: any medical information needed by authorized people should be accurate and readily available.
- Integrity: patient or client information shouldn’t be altered in any way and should be a true reflection of the person’s health.
- Confidentiality: the PHI should only be shared with people that are authorized to access it.
HIPAA regulations also cover ePHI or electronic protected digital health information, which is any PHI that can be accessed, stored, or transmitted electronically. This type of PHI falls under the HIPAA Security Rule, which was added to HIPAA regulations to accommodate the changes that occur in medical technology.
What Are the Main HIPAA Rules?
It has been more than 2 decades since the HIPAA regulations were passed. The main rules include;
- HIPAA Security Rule
The HIPAA Security Rule sets and regulates the national standards regarding the secure handling, transmission, and maintenance of ePHI. It applies to both business associates & covered entities because they have a relationship that could result in them sharing ePHI. This rule highlights the safety and integrity standards of ePHI, including the technical, administrative, and physical safeguards that are mandatory in healthcare organizations.
Here’s a quick overview of the safeguards:
- Technical: this mostly revolves around cybersecurity and includes elements such as network security, mobile devices, computers, device security, encryptions, and all technological tools involved in the communication and storage of ePHI.
- Physical: these safeguards limit access to data storage tools, switches, routers, and computers. All covered entities should store their physical equipment in secure areas that are only accessible to authorized personnel.
- Administrative: they cover the procedures and policies that affect ePHI and the risk management, system design, maintenance, and technologies involved in security measures. It also covers elements of healthcare administration such as employee training and human resources.
The organizations must document their policies and procedures regarding the HIPAA Security Rule, train the employees each year, and document the attestation.
- HIPAA Privacy Rule
The HIPAA Privacy Rule highlights the standards you should meet when it comes to patient PHI. It doesn’t cover business associates but instead applies to the covered entities. This rule outlines standards such as:
- The rights of healthcare providers when it comes to denying PHI access.
- Patient rights in accessing PHI.
- Notices of privacy practices.
- The use and disclosure of HIPAA procedures and policies.
According to the HIPAA privacy rules, business associates and employees can only disclose privileged health data in scenarios that involve legal situations or specific research and care. You should, however, note that these situations are limited and are subject to a court of law's interpretation. As a general rule of the thumb, protect PHI and ePHI at all costs.
All organizations must document their regulatory standards regarding HIPAA policies and procedures and train their employees every year on the same. The results of the training also need to be documented.
- HIPAA Breach Notification Rule
The HIPAA Breach Notification Rule lays out the standards that business associates and covered entities should follow when they experience a data breach involving PHI and ePHI. It also highlights the various requirements for reporting a breach based on its size and scope.
Even though organizations are required to protect patient data, it’s very difficult to do so with full effectiveness. This is why you should put plans in place to notify victims and the public about a HIPAA breach and outline the next steps you plan on taking. According to the breach notification rule, some of the steps that organizations should take to stay in compliance include:
- Using local media outlets to issue a public notice of the HIPAA breach if it impacts more than 500 people within a certain jurisdiction.
- Informing the victims of the breach by issuing a formal and written notice of the incident either through email where applicable or by first-class mail.
- In cases where the entity doesn't have the contact details of over 10 customers, they should use alternative ways of issuing a notice of the breach. For instance, they could use a major broadcast news or printing source or post on their site for at least 90 days.
- Entities should issue a notice of the breach within 60 days after discovering the breaches.
- If the breach victims are more than 500, the entity should notify the Secretary of Health no later than 60 days, but if the victims are less than 500, they have until the end of the year to issue a notice.
You should, however, note that all organizations must report breaches to the HHS and OCR irrespective of their magnitude. The only thing that changes is the reporting protocols based on the type of breach.
- HIPAA Omnibus Rule
The HIPAA Omnibus Rule is a HIPAA regulation addition that was included to accommodate business associates. It outlines the mandatory rules surrounding BAAs ( Business Associate Agreements) and states that all business associates should comply with HIPAA regulations. The HIPAA Omnibus Rule also states that a BAA must be executed before any PHI or ePHI can be shared or transferred between 2 business associates or a business associate and a covered entity.
Who Needs to Be HIPAA Compliant?
There are 2 groups that should be compliant with HIPAA standards; covered entities (organizations that handle PHI directly) and business associates (organizations that offer services to covered entities). Here’s a quick overview of both.
- Covered entities: they include healthcare payers such as insurance companies and healthcare providers such as digital clinics, hospitals, and private practices. Covered entities are regulated directly by HIPAA rules because they have first-hand interaction with PHI. They can be federal or state agencies, individuals, for-profit businesses, and even non-profit organizations.
- Business associates: even though healthcare providers and payers have direct access to patient data, most of the time, they use service providers and digital healthcare app developers to process or store PHI. These third-party service providers are referred to as business associates and are required to sign a Business Associate Agreement and comply with the best data protection practices. Healthcare mobile app developers that sell electronic software or clinics are a great example of business associates.
If you develop HIPAA-compliant healthcare apps, there's a high chance that you've been frequently asked to execute business associate agreements. This means that you accept liability and responsibility for any PHI that you have access to and agree to be HIPAA compliant.
There are instances where the health care provider that you’re working with includes more requirements on the agreement, in addition to those required by the law. There are also some covered entities that will ask you to execute a BAA even though you don’t have to process any PHI.
An Overview of HIPAA Violations
HIPAA violations occur when covered entities or business associates fail to comply with the regulations outlined in the privacy, security, breach notification, and omnibus rules. Examples of these violations include:
- Unlawfully exposing ePHI or giving access to unauthorized parties, whether accidentally or willfully.
- Failing to notify public officials and victims of data breaches within the set timeframes.
- Failing to implement the necessary security protocols in accordance with the HIPAA security rule.
- Failing to wilfully address, upgrade or update any HIPAA compliance gaps in your organization.
- Lacking the necessary training and administrative protocols required to meet HIPAA requirements.
There are 2 main types of HIPAA violations; civil and criminal.
- Civil HIPAA Violations
These violations occur when the non-compliance is done without malicious intent or accidentally, either due to lack of awareness or neglect. The penalties are less severe compared to those of criminal HIPAA violations and include:
- A $100 fine per incident for violations caused by lack of awareness.
- A $10,000 per incident for violations due to willful neglect.
- For cases where there’s a reasonable cause but no neglect, the minimum fine is $1,000.
- A $50,000 fine per incident for instances where there’s willful neglect but no immediate efforts to rectify the violation.
- Criminal HIPAA Violations
These are HIPAA violations that are done with malicious intent, such as fraud or theft. The penalties are harsh and include:
- Up to 10 years in jail and a $250,000 fine for violations committed with the intent of making a profit.
- A 5-year jail sentence and up to $100,000 for violations that involve fraud.
- 1-year jail term and up to $50,000 for violations that involve knowing, acquiring, and disclosing ePHI to unauthorized parties.
Depending on the nature of the violation, the fines can amount up to millions of dollars annually, especially when committed numerous times and repetitively.
The main common types of HIPAA violations include:
- Lost or stolen devices: as more healthcare providers shift toward mobile devices such as smartphones, tablets, and laptops, there's a high likelihood that they could get lost and end up in the wrong hands.
- Fraud: this is the most common HIPAA violation and is mostly committed with the intent of making a profit. Fraud often occurs when healthcare providers use unreliable service providers, but in rare instances, it could result from insider operations.
- Lack of or insufficient protection: some organizations fail to comply with the HIPAA security rule that highlights the mandatory firewall, encryption, and security measures that should be implemented and end up working with non-compliant third-party associates.
- Unauthorized PHI access: in large organizations, it's easy for unauthorized parties to access ePHI or transmit it inaccurately. This is especially common during emergency situations when healthcare workers need quick access to patients' information and is the most common type of civil HIPAA violation.
How to Avoid HIPAA Violations - A Checklist
The simplest and most effective way to avoid HIPAA violations is by staying compliant. Here’s a simple checklist to help you:
- Make sure that all your security technologies are HIPAA compliant. This includes the encryption of data that’s at rest, in use, or in transit. You should also use centralized data access controls to enforce data authorization policies within the system.
- Ensure that all software is updated to the latest versions to maintain high-security standards.
- All administrative activities should be in compliance with the HIPAA security & privacy rules and should be accompanied by data governance & access policies and procedures for enforcement.
- You should have a HIPAA compliance officer to ensure that all branches of your organization are in compliance.
- If you work with other security and technology vendors, they should be knowledgeable in HIPAA compliance. In addition, every security file transfer, software, and cloud tech that they provide should match the set requirements.
- If there’s a chance that other contractors will handle ePHI, you should audit them to make sure that they’re in compliance.
- All organizational mobile devices should be tracked to make sure that even if they are misplaced, they don't end up in the wrong hands. They should also have remote wipes protocols in place to destroy all stolen information, and the data they contain should be encrypted.
How to Make Your Apps HIPAA Compliant
There are several requirements that you need to meet to develop HIPAA Compliant mHealth Apps:
- Backup and storage encryptions: Healthcare mobile app developers that provide recovery or backup services should ensure the data is securely stored and can only be accessed by authorized personnel. Keep in mind that you'll be dealing with sensitive patient health information, and if this data is stored in shared resources such as common servers, they could be compromised, which is why all data should be encrypted.
- Transport encryption: if you'll be transmitting ePHI, make sure you only use HIPAA compliant software that will encrypt all privileged information. Secure it using HTTPS and SSL protocols and ensure they're properly set up and that there's no insecure or expedited TSL. You should also use hash values to store and transmit passwords to prevent the data from being compromised.
- Integrity: all data that you collect, transfer or store should be accurate and unaltered. Your systems should also be able to identify and report all data interference, no matter how small.
- Identity and access management: HIPAA rules are very precise about the security levels that should be maintained when it comes to data protection and privacy. Ensure that all the user IDs, passwords, and institutional data are secure. The system should also keep track of all login attempts and keep access and event logs. Some of the most effective identity and access management procedures include Two Factor Authentication, Single-Sign-On, and biometrics.
- Data disposal: all archived and backed up data that has expired should be disposed of permanently, as well as the decryption keys. The same applies when you also stop using a server.
- Business associate agreements: this is the final piece of the puzzle. Make sure all the ePHI is hosted on secure in-house servers or those of a HIPAA compliant company that you sign a BAA with. Some of these providers include Google Cloud Platform, Microsoft Azure, and Amazon Web Services.
How Apzumi Can Help You to Follow HIPAA Rules
Apzumi is a full-service development company that specializes in digital health, wellness, and fitness. Our main role is to be your reliable technology partner when it comes to HIPAA compliant healthcare apps for use with medical devices, web portals, digital health marketplace, or medical data analysis. One of the elements that make us different is that we combine both domain and technical expertise to develop an app that meets all your compliance needs.
Looking for dedicated healthcare mobile app developers? Let us help you! Contact us today for an interactive and engaging consultation.