What is the impact of HIPAA Compliance on Healthcare Application?
In the booming digital era, technology has become an integral part of the healthcare sector. Today the healthcare industry has heavily invested in advanced technology for performing its daily operations. However, with growing digitization and increased risks of cyber threats, regulators in the US expect organizations in the healthcare sector to comply with HIPAA requirements. With increasing healthcare engagement apps used by healthcare organizations and their customers, the trend has led to a good amount of highly sensitive data flow through these apps. The data collected, stored, and used in these apps and devices include everything from name, gender, blood groups, geographic location to medical records to medical history to biometric identifiers, photos, and much more. Any mobile applications that handle Protected Health Information (PHI) in the U.S. must comply with Health Insurance Portability and Accountability Act (HIPAA) regulations. Explaining more on this in detail, we have covered how HIPAA impacts healthcare applications and how the HIPAA Security Rule applies to the apps.
How does HIPAA Compliance apply to Healthcare Applications?
Digital healthcare applications that collect sensitive PHI data call for a significant compliance responsibility for the app developers. This is to ensure the security of sensitive PHI data. So, any mobile applications that handle Protected Health Information (PHI) in the U.S. must comply with Health Insurance Portability and Accountability Act (HIPAA) regulations. PHI is any personally identifiable medical information stored, transmitted, or used for providing treatment, payments, services, or operations in the healthcare industry. So, healthcare apps used for medical examination, usage, and other healthcare engagements, involving the use of PHI data are considered Personal Health Record (PHR) devices that fall in the scope of the HIPAA Regulation Act.
However, it is important to note that not all healthcare applications fall in the scope of HIPAA Compliance. So, for instance, applications that require users to enter their information will not have to comply with HIPAA. This may include apps like a fitness-tracking app that asks for the end-users weight, height, and medical background. So, here if the user enters all this data on their own using their equipment, in that case, the app developer does not have to comply with HIPAA. But if an app is developed for a Covered Entity or is used for providing services by a Business Associate, HIPAA may apply to those app developers. A good example of this would be the insurance provider, who uses specific software applications that track consumers’ claims and other coverage details. The information provided or available in the application is populated by the insurance provider, making the application in use and the information collected in the scope of HIPAA.
As per HIPAA guidelines, developers may fall in one of the following two categories: either the Covered Entities or Business Associates.
- Covered Entities are defined as health plan providers like insurance agencies, health care clearinghouses, and health care providers who electronically transmit PHI data.
- Business Associate is defined as a person or an entity that performs certain functions or activities that involve the use or disclosure of PHI on behalf of a Covered Entity or involves providing services to a Covered Entity.
So, with this, the digital healthcare ecosystem will include a range of entities who may be affected by the HIPAA Regulation directly or indirectly. The HIPAA regulation has a widespread impact on various entities, and there is no exception. That means developers cannot just ignore the applicability of HIPAA compliance with the thought that they are not handling the PHI data. That said, Application development vendors building healthcare applications may have to comply with HIPAA requirements, specifically the Security Rule, if they fall in scope.
Impact of HIPAA Compliance on Healthcare App
HIPAA Compliance probably applies to every aspect of healthcare practices in the industry. This would even include the healthcare app developed for storing and managing sensitive PHI Data. Application development is a complicated process that requires the vendor to balance business goals, good user experience and ensure the product’s scalability. With that, HIPAA Compliance will be an added pressure on the developer to comply with the regulation. Healthcare Application development vendors need to understand that HIPAA compliance requires a blend of the right system design and data security. The vendor is required to develop systems that ensure the security of PHI Data stored on managed software. Even developers with vast experience may not live up to the HIPAA Compliance requirements, for it is an entirely different set of requirements.
HIPAA requires organizations to implement various security standards on transmitting and storing Personal Health Information. It defines implementing standardized formats for the transmission and storage of PHI data. So, businesses involved in creating applications that store, maintain, or transmit PHI data are required to comply with HIPAA norms. These businesses or IT service providers are termed as Business Associates. They are required to consider certain security standards when dealing with PHI from health organizations.
What is expected from Healthcare organizations and Business Associates?
Hardware Developers- For implementing certain security standards when dealing with PHI data, healthcare organizations are expected to work with their Business Associates to implement different policies regarding developing the hardware and other electronic devices. These policies must include risk evaluation storage and security measures.
Software Developers- Cyber-attacks on software applications is one of the major reasons behind the development and implementation of HIPAA regulation in the healthcare sector. Healthcare organizations are expected to work with Business Associates to implement different policies and procedures regarding developing software applications storing and transmitting PHI data. This should include implementing relevant security measures for protecting the PHI data.
Cloud Service Providers- More than often, an organization’s data is either hosted on the cloud or dedicated/physical servers. Speaking about the healthcare industry, the data is stored on servers. So the IT service providers associated with the healthcare organizations must comply with HIPAA regulations. So with that said, they must follow various security rules and even comply with various encryption policies outlined in the HIPAA Regulation.
How Does the HIPAA Security Rule Apply?
Application Developers who must comply with HIPAA are required to focus on HIPAA Security Rule specifically. The HIPAA Security Rule applies to both Covered Entities and Business Associates who are required to ensure the confidentiality, integrity, and availability of all electronic PHI (ePHI) stored, transmitted, and maintained in the application. The Security Rule calls for the Covered Entities and Business Associates to implement the following three security safeguards –
- Administrative Safeguards – Covered Entities and Business Associates must have policies and procedures in place, including rules to be followed for developing, implementing, and maintaining security measures to protect ePHI. It should also include procedures and guidelines to be followed by employees to protect that information.
- Physical Safeguards–Covered Entities and Business Associates are expected to implement security measures to limit physical access to devices and applications to unauthorized personnel. They are also required to have policies and procedures that specify appropriate use and access to devices, electronic media, and applications containing ePHI data. The policies and procedures must also include guidelines for transfer, removal, disposal, and re-use of electronic media to protect electronically Protected Health Information.
- Technical Safeguards–Covered Entities are expected to implement technical policies and procedures that limit access to only authorized persons to access e-PHI Data. Further, they are expected to implement hardware, software, and/or procedural mechanisms to record and examine access and other activity in information systems that contain or use e-PHI. It also requires mechanisms to ensure technical security measures like encryption that secures against unauthorized access to e-PHI transmitted over an electronic network.
HIPAA requires application developers to evaluate potential vulnerabilities, threats, and risks that could impact the confidentiality, availability, and integrity of ePHI. The HIPAA Security Rule also requires the Covered Entities or Business Associates to perform Risk Analysis to identify and determine appropriate safeguards for implementation. This requirement is limited to systems and devices and an application that requires app developers to implement privacy-by-design principles in the application development lifecycle and further consider various data protection standards and mechanisms.
Conclusion – Ensuring HIPAA Compliance for HealthCare App
Healthcare Application development is a complicated process and involves the app developers adhering to certain HIPAA Security Rules. For adhering to these rules, understanding HIPAA Compliance requirements is crucial. Developers are expected to effectively balance application design and security to ensure the Healthcare Application is HIPAA Compliant. We strongly recommend consulting an expert for the same for those developers who have not engaged in the industry and do not hold experience in developing HIPAA Compliant apps. This is mainly because even experienced application developers may not develop a HIPAA compliant app if they are not aware of the compliance requirements.
Narendra Sahoo (PCI QSA, PCI QPA, CISSP, CISA, and CRISC) is the Founder and Director of VISTA InfoSec, a global Information Security Consulting firm based in the US, Singapore & India. Mr. Sahoo holds more than 25 years of experience in the IT Industry, with expertise in Information Risk Consulting, Assessment, and Compliance services.
VISTA InfoSec specializes in Information Security audit, consulting, and certification services, including GDPR, HIPAA, CCPA, NESA, MAS-TRM, PCI DSS Compliance: Audit, PCI PIN, SOC2, PDPA, PDPB, to name a few. For years (since 2004), the company has worked with organizations across the globe to address the Regulatory and Information Security challenges in their industry.
VISTA InfoSec has been instrumental in helping top multinational companies achieve compliance and secure their IT infrastructure.