There is only one rule that governs the era we live in today – data is gold. The industry that deals with users’ data (sensitive or not) is bound to have some compliances in place to safeguard it.
In this mobile-first era, healthcare is also not exempt from strict compliance regulations designed to prevent users’ data from being misused.
There are many compliances across nations, but HIPAA, the Health Insurance Portability and Accountability Act, is universal on many grounds.
Ensure your app meets all the requirements of HIPAA compliance by learning how to develop a HIPAA-compliant app.
What is the HIPAA act?
The HIPAA Act ensures patient data is handled and stored securely, especially on a software platform. In addition, billing and healthcare insurance coverage information is shared for medical patients.
HIPAA compliance for mobile apps was developed in 1996 to protect patients’ data, lower healthcare costs, and provide health insurance coverage to people who lost or changed their jobs. Our concern as developers and yours as app entrepreneurs is the requirement that the app protects users against data theft.
Do You Have a HIPAA-Compliant App in Development?
Regulations governing the lawful use and maintenance of protected health information (PHI) were enacted in 1996 under the Health Insurance Portability and Accountability Act (HIPAA). A patient’s PHI is any demographic information that can be used to identify the patient. For healthcare organizations to ensure the privacy and security of PHI, HIPAA regulation should be implemented through a culture of compliance.
Under HIPAA, healthcare providers are not the only covered entities required to comply with the law. Business associates are also identified in the regulation. Any organization providing services related to PHI to another HIPAA-governed entity is a business associate. To name a few, this includes organizations that provide IT services, IT infrastructure, mobile app development, and web portal development. Under HIPAA regulation, any information shared with a business associate-including healthcare apps that maintain ePHI-must be accompanied by a business associate agreement (BAA).
As part of a proper HIPAA compliance program, healthcare software development apps must also adhere to the Seven Fundamental Elements.
HIPAA-compliant apps must comply with the Seven Fundamental Elements of an Effective Compliance Program to meet HIPAA privacy and security standards. There are seven elements in the Seven Elements:
- Developing and implementing written policies, procedures, and standards of conduct
- Establishing a compliance officer and a compliance committee
- Providing effective training and education
- Establishing effective communication channels
- Auditing and monitoring internal processes
- Providing well-publicized disciplinary guidelines to enforce standards
- Taking corrective action when offenses are detected and responding promptly
HIPAA: An Overview
In order to maintain the confidentiality, integrity, and availability of protected health information, the HIPAA Security Rule sets specific standards. The following three HIPAA security safeguards must be implemented by HIPAA compliant apps to protect ePHI:
- A technical safeguard involves cybersecurity and network infrastructure, such as firewalls, encryption, and malware prevention.
- A physical safeguard is anything that limits access to ePHI maintained or housed on a physical site, such as locks or alarms.
- To ensure that security standards are properly followed throughout the organization, administrative safeguards entail policies, procedures, documentation, and staff training.
Technical and physical safeguards are essential components of a HIPAA-compliant app and must be considered throughout the process of development.
Getting Your App HIPAA Compliant!
No matter whether you run a healthcare practice or develop a HIPAA compliant app, you must comply with these standards to ensure sensitive information is protected.
1. Safeguards on a technical level
Technical security safeguards under HIPAA include:
Control of access
A proper implementation of access controls allows only authorized individuals to access ePHI, including:
- User identification – Software systems must provide unique identifiers so that each user has his or her own login credentials. Additionally, employees should not use the same username or password for multiple accounts.
- Procedures for emergency access to ePHI- During an emergency, access to ePHI should be possible.
- After a specified amount of time, the system must automatically log the user out of their session.
- EPHI must be encrypted and decrypted before it is stored on an app or software system.
Controls for audits
HIPAA-compliant apps must include hardware, software, or procedural mechanisms to examine and track ePHI activity.
There must be mechanisms in place to protect the integrity of the ePHI within the HIPAA compliant app to prevent it from being unintentionally modified or corrupted. HIPAA regulation defines integrity as guaranteeing that the information being accessed is not damaged, lost, or altered in any way.
Authentication of persons
The purpose of this step is to confirm that the person logging onto the system or app is who they claim to be.
Security of transmission
In order to ensure that ePHI transmitted over the internet or any communication network is not altered, all data must be encrypted and specific mechanisms must be implemented to ensure that all data is encrypted.
2. Safeguards on a physical level
To protect ePHI that can potentially be accessed, healthcare organizations and IT providers need physical safeguards. HIPAA’s physical security safeguards include:
Control of facility access
By using these, the access to the facility where ePHI is stored will be physically restricted, allowing only those with authorization to access it. Furthermore, implementing facility access control policies and procedures will prevent unauthorized access to hardware.
Use of workstations
Devices used as workstations, such as laptops, smart phones, tablets, etc., must be logged off before leaving the area unattended. Devices that leave the premises should have the necessary technical safeguards in place, including antivirus software that is up-to-date.
Security for workstations
The monitor of a computer should not be visible to anyone other than the employee using it. Screensavers must be password-protected on all systems.
Controls for devices and media
Whenever software containing PHI is disposed of, all data should be wiped to remove any sensitive information. Any healthcare data on a HIPAA compliant app must be deleted.
3. Safeguards in the administrative process
To protect electronic health information, these safeguards develop, implement, and maintain security measures.
- When developing HIPAA-compliant apps, Information Access Management is crucial to ensuring only relevant ePHI is accessible.
- An individual user should only be able to access ePHI relevant to his or her job function, and not other ePHI for a particular patient.
- ePHI security policies should be regularly communicated to employees through regular training.
- It is imperative to implement a contingency plan to notify affected parties in the event of a breach.
How do I build a HIPAA-compliant mobile app?
The process of developing HIPAA-compliant applications is different from the process of developing any other type of application. It must be developed with precision and in accordance with the guidelines and rules.
The features of a HIPAA-compliant application
Identification of the user
HIPAA compliance cannot be achieved by allowing users to log in using their email address. Passwords and PINs can be used for user authentication. Moreover, it can be a smart key, a smart card, or a biometric identification system. If you are planning to build your own app, keep this aspect in mind.
Utility services and essential services can be disrupted during times of emergency. Under all circumstances, data access must be maintained.
Make sure there is a way around it. During a natural disaster or when there is no electricity. It’s not a direct requirement for HIPAA compliance, but it’s a necessary feature for healthcare apps.
The encryption process
Encryption of data is always necessary in applications for healthcare. Emails are not encrypted, so sharing information via them is not allowed.
A state of rest (meaning the data is not shared). Encryption is required regardless of whether it is stored on a cloud server or a SaaS service.
Encryption of data in transit
Use cloud computing services such as Amazon Web Services or Google Cloud. During transmission, these services encrypt data. These technical safeguards have been established by the Department of Health and Human Services.
All encryption, authentication, and identification specifications are addressed by these safeguards. When developing HIPAA-compliant mobile apps, they should be installed.
Encryption with TLS should be put in place end-to-end. Inbound or outbound packets must be encrypted with TLS. Adding AES encryption will further strengthen this.
What is the cost of building a HIPAA-compliant application?
As well as the question of how to make an app for hospitals, there is a question of cost. In order to develop a HIPAA-compliant mobile app, several factors must be taken into consideration:
- An organization’s size and type
- The application’s complexity
- The number of roles assigned to each user. Among these are hospital roles, administrator roles, doctor roles, and patient roles.
You must therefore understand the main values you’ll provide to create an MVP and build a HIPAA compliance application. Making a budget-wise project plan is easier when you focus on core features.
Depending on the executors, the cost of mobile app development will vary. Nevertheless, the common development team knows how to create apps. However, finding a team with expertise in HIPAA compliance app development is a challenge.
Several options are available to you. There are benefits and drawbacks to each of them:
- An agency in your area. Depending on the service, the cost may range from $100 to $250 per hour. So let’s say the average price per month is $64,000. You can test business hypotheses with this method if your budget is unlimited.
- An in-house team. For startup founders, it is the most reliable option. A monthly fee of up to $25,000 is charged. The lack of business analysis, project management, and development expertise are some of the risks associated with building a team from scratch.
- The freelancers. There is no better way to do it. It will cost up to $13,000 per month on average. In spite of this, there are plenty of risks involved: spending of own resources, lack of expertise, and unreliable collaboration.
- Development outsourcing. The cooperation is both reliable and of high quality. The monthly cost will be up to $19,000. There are, however, many countries to choose from. In spite of this, there are many teams with expertise and experience to begin developing HIPAA compliance apps.
HIPAA compliance rules and regulations carry heavy penalties for noncompliance. Depending on the size of the breach, it can range from $1,000 to $1.5 million per year.
Implementing precise BAAs, conducting third-party audits, and developing proactive applications. The development of HIPAA-compliant apps isn’t as easy as it sounds.
Several factors play a role in this process. Developing a mobile app requires all these procedures and processes, whether you are a developer or a vendor. It is imperative to get and store information in accordance with HIPAA regulations.
This is why you need to retrieve only the information that is needed and that can be secured. Building HIPAA-compliant apps is only possible after obtaining all the necessary information.