The process of developing a HIPAA complaint app varies from a general application development, as aspects such as ePHI security, access control, and audits are mandatory requirements for a HIPAA compliant application.
HIPAA violations cost around $100 to $50,000 per violation, which can result in millions of dollars of penalties, hence the need to adhere to strict protocols while developing a HIPAA compliant healthcare application.
8 Steps For HIPAA Compliant App Development
1. Partner With a HIPAA Compliant Software Development Company
Prior to shortlisting a HIPAA compliant software development company, clearly define expectations and objectives from developers, then look for a development company that specializes in healthcare industry and is HIPAA compliant.
Skilled developers understand business goals and applications’ roadmap easily, based on which a productive workflow is set to integrate functionalities, compliance, and features. For validating competence of a software development company, check case studies, portfolio, awards, and ratings to shortlist a top-rated provider for app development.
Experience and technical expertise in the field adds on to the credibility and authenticity of the work done, also ensuring that the company can provide best-in-class services. Arkenea specializes in HIPAA compliant healthcare app development, which is customized according to the taste of the medical industry.
Discuss budget with the company and set transparent cost estimates as per objectives and requirements. Furthermore, ensure that service providers build a HIPAA compliant UX/UI design, that’s virtually attractive, consists of intuitive features, and is user-friendly.
2. Encrypt all Transferred and Stored PHI Data
Cracks in HIPAA compliance that undermine protection of ePHI, thus opening up compliance issues and resulting in exposing data are stolen or lost devices, unsecured servers and email systems, staff training, weak encryption, and rotating encryption keys. Strong encryption is required during HIPAA compliant app development to safeguard sensitive patient data. To assure security, HIPAA has set three foundational rules that developers adhere to while developing application, and these are –
1. The Privacy Rule that signifies PHI and documentation
2. The Security Rule that maintains security standards for transmission and storage of ePHI.
3. The Breach Notification Rule that defines protocols for reporting a HIPAA breach to patients and authorities.
To avert cracks in HIPAA compliance during app development, three key security measures that can be taken are –
1. TLS (Transport Layer Security): This protocol ensures secure data transfer over email, messages, and web (https). TLS uses AES-256 security measures to safeguard data transfer.
2. AES-256 (Advanced Encryption Standard): This is a systematic method created by the US National Institute of Standards and Technology, and is approved for handling confidential data by the US Government.
3. OpenPGP (Pretty Good Privacy): This is compliant tool, however needs a complex public key management that can be time consuming for organizations.
3. Implement Access Control Mechanism
Ensure to include restriction access on confidential information while developing a HIPAA compliant application, because as per privacy rules, only authorized individuals are required to access PHI.
Access controls falls under the technical safeguards of HIPAA rules, and this defines access as the means or the ability necessary to write, read, communicate, or modify data or otherwise use system resource. Access control under HIPAA offers privileges to users to access and carry out functions using applications and programs.
Authorization is granted based on the rules covered entities incorporates under the Information Management Access section of the Administrative Safeguards.
Four ways to ensure access control during HIPAA complaint app development are automatic logoff, emergency access procedures, unique user identification, and decryption and encryption of data.
4. Build a Robust Backup and Security System
HIPAA rules require service providers to incorporate a full backup schedule of the whole healthcare organization that contains patient data or any devices that handle ePHI. The preferred backup routine is once everyday and to archive weekly, monthly, and yearly data.
While developing app, ensure to adhere to HIPAA regulations that mention requirements during a backup and recovery plan. These include –
2. Transmission security
3. Revision and testing process
4. Risk management
5. HIPAA disaster recovery plan
6. Data backup plan
7. Contingency plan
Seek a HIPAA complaint data backup and recovery service provider to meet the requirements during app development. Further, the objective of formulating a robust disaster recovery plan is to assure that organizations can recover crucial IT components that manage PHI to run normal business functions.
5. Incorporate PHI Disposal Protocols
Ensure to have a PHI disposal policy and procedure in place while developing a HIPAA compliant app, as according to regulations business associates, covered entities, and business associate subcontractors are required to train members and have policies for the disposal of PHI safely. The HHS (US Department of Health and Human Services) recommended three techniques to dispose PHI safely and these are –
1. Purging: Organization can purge their hardware with a method call as degaussing, which means clearing a device by using magnets. By using a strong magnetic field, one can disrupt a devices’ function and make data as unreadable.
2. Clearing: This technique is also referred to as overwriting, and it is a procedure of replacing PHI on a device with non-sensitive information. Its recommended to perform this technique at least seven times to completely erase ePHI records.
3. Physical Destruction: This is the only way to ensure 100 percent data destruction, and involves numerous ways such as burning, pulverizing, shredding, or disintegrating.
6. Ensure Audit Controls
The HIPAA security rule requires business associates and covered entities to incorporate software, hardware, and procedural mechanisms to scrutinize and record information system that uses or holds ePHI.
The security rule mentions audit controls as one of the four main areas for business associates and covered entities when incorporating technical safeguards. Audit controls are reviewed along with integrity controls, access controls, and transmission security.
The healthcare organizations can consider audit controls in case of the following situations –
1. Tracking unauthorized disclosures of ePHI
2. Inappropriate access
3. Detecting flaws and problems in applications
4. Rendering forensic evidence during investigation of breaches and security incidents.
5. Detecting malicious activities and intrusions.
Consider reviewing audit trials regularly, both during real-time operations and post any security situations, or when a data breach has taken place.
7. Remove PHI From Push Notifications
Mobiles are insecure devices and push notifications are used by several applications to notify the user about changes and updates, thus risk violating privacy rules defined under HIPAA.
Ensure not to use push notifications while developing a HIPAA complaint application as these notifications are visible even when phones are locked, thus hampering privacy of patients.
Likewise, refrain from mentioning sensitive data in emails or messages unless consent is provided by the patient, as due to unsecured lines or communication channels, all personal data maybe compromised.
8. Maintenance and Testing of HIPAA Compliant Application
Testing of application helps to evaluate the strength of data encryption by checking authorization processes and gateways. Aspects checking during testing are access control, encrypted data transfers, audit trail, failover/load balancing, and more.
Application maintenance requires continuous analysis, updating, modifying, and re-evaluating of the existing software applications. Maintenance is an ongoing process that assures applications are running to the best of their abilities.
To get the best-in-class customized HIPAA compliant app development, get in touch with Arkenea – a leading health tech company that specializes in creating healthcare applications, software products, and medical websites that meet industry standards.