At some point, however, questions need to be asked about the kind of data that the application may be gathering and how that information is managed. If there is a potential that this may include healthcare-related information, then steps must be taken to ensure that the solution is HIPAA compliant. This should be an even greater priority if the team plans to add features like eSignatures, forms, and workflow automation tools by using a third-party API.
What is HIPAA Compliance?
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) established several guidelines to ensure that healthcare organizations and their vendors have the controls and processes in place to keep sensitive patient data both secure and confidential. Any company that handles protected health information (PHI) is required to meet these standards, even if it is not directly involved in the healthcare industry itself. A payment processing company that manages patient transactions for a hospital, for instance, must have systems in place to comply with HIPAA regulations, even though it does not provide health services. This is because the information collected could be used to identify patients and expose treatments they’re receiving.
Although HIPAA predates much of today’s healthcare technology, the law was updated by the Health Information Technology for Economic and Clinical Health Act (HITECH) in 2009 to address various loopholes and make more parties subject to data breach penalties. The law makes no distinction between PHI that exists in physical form (on charts or documents, for example) and electronic health information (ePHI). Both are fully protected under HIPAA standards.
There are three core HIPAA compliance rules that apply to any organization or individual (often referred to as “covered entities”) that handles PHI:
- Security Rule: Requires any covered entity accessing or handling PHI to have technical, physical, and administrative protections in place to keep data secure.
- Privacy Rule: Establishes how PHI can be used and disclosed by covered entities, whether by electronic means, through physical paperwork, or verbally.
- Breach Notification Rule: Requires covered entities and all business associates to notify patients and the Department of Health & Human Services of a data breach involving PHI.
Becoming HIPAA Compliant
Establishing HIPAA compliance is a long and often expensive process that involves implementing a variety of cybersecurity measures as well as developing multiple procedures for handling sensitive data. Just a few of these steps include:
- Performing a HIPAA gap analysis to identify security deficiencies
- Creating documented remediation plans to address deficiencies
- Providing HIPAA training to employees
- Designating or hiring a HIPAA compliance officer
- Developing and maintaining policies and procedures for HIPAA Security, Privacy, and Breach Notification Rules
- Assessing the HIPAA compliance of business associates
- Defining processes for security incidents and data breaches
Meeting the requirements for each compliance rule is a complex and time-consuming process. For instance, the HIPAA Security Rule alone has over 70 requirements with more than 200 validation points, each of which may require substantial changes to an organization’s IT infrastructure to satisfy.
In order to finally be certified as HIPAA compliant after laying the proper foundation, an organization must then undergo an audit by a third-party compliance expert. This thorough process will look at several areas of compliance:
- Compliance with the technical, physical, and administrative protections of the HIPAA Security Rule, including asset & device audits, IT risk analysis, location audit, security standards review, and more.
- Review of policies and procedures designed to address HIPAA standards and document “good faith” compliance efforts.
- Assessment of employee compliance training programs
- Audit of all documentation required by HIPAA standards
- Evaluation of incident management procedures for data breaches and reporting
- Review of “due diligence” policies for business associates and vendors
Given the complexity of this process, it’s difficult to predict just how long it will take to achieve full compliance with HIPAA. A large organization can easily take as much as 2-3 years to become HIPAA compliant, if it’s starting from scratch. Even small to medium organizations can take 1-2 years to satisfy requirements, especially if they don’t have a full-time person dedicated solely to HIPAA compliance.
Does Your Application Really Need to Be HIPAA Compliant?
Given the tight deadlines and limited resources facing most software developers, it’s often tempting to question whether or not an application really needs to be HIPAA compliant if it’s handling any data that could potentially be health-related. After all, a lot of data that may sound like it falls into the category of PHI isn’t legally considered protected information. So if there’s some ambiguity about the data an application is working with, or if it doesn’t obviously fall into the category of PHI, does the software still need to be HIPAA compliant?
In a word? Yes.
Fines and penalties for HIPAA violations are among the largest and most high-profile regulatory actions taken by the government. Individual penalties can be as high as $50,000 per violation and carry a criminal penalty of up to 10 years in jail. These penalties can be levied at both the federal and state level, which increases the potential for exposure. The health insurance carrier Anthem was hit with a record $16 million HIPAA penalty in 2018 for a data breach involving nearly 79 million customers.
But penalties aren’t only reserved for healthcare organizations themselves. In 2018, for instance, the State of New Jersey fined a medical transcription vendor $200,000 after a server misconfiguration exposed the PHI of over 1,500 patients. The payment processing vendor, American Medical Collection Agency (AMCA) was quickly driven into bankruptcy and faced lawsuits from 41 states after a 2018-2019 data breach affected roughly 20 million people.
Put simply, the potential risks associated with a HIPAA-related data breach are too great for any organization to take chances. Given the number of high-profile violations involving healthcare software vendors, companies are subjecting their potential partners to far greater scrutiny than ever before. If a developer can’t demonstrate that their applications and infrastructure for handling data are HIPAA compliant, they will have a hard time competing for customers in the healthcare technology market.
Benefits of Working with a HIPAA-Compliant API
Software developers looking to gather eSignatures and form information from users within their applications need to put a lot of thought into how their customers may ultimately use those capabilities. If they intend to collect data that could fall under HIPAA’s definition of PHI, then the platform needs to handle and store that data in ways that meet compliance standards. Furthermore, everyone associated with managing that information must possess the proper training and have a strict process in place to ensure that privacy is protected at all times.
Undergoing the long and expensive journey to formally obtain HIPAA compliance is not a realistic option for many software developers. Even if they had the resources available to become compliant and maintain that status, pursuing that goal could potentially push their time to market back by years.
By integrating key application features like eSignature and forms workflows with a HIPAA-compliant API, however, developers can keep their projects on schedule and within budget without compromising privacy or security. Implementing a HIPAA-compliant API solution also eliminates uncertainty about whether special precautions need to be taken with certain types of data. For companies that don’t have a HIPAA compliance officer or legal department specializing in healthcare data, working with a third-party API vendor can provide peace of mind for both the development teams and customers.
Keep Your Application HIPAA Compliant with Docubee API
Docubee API is a fully HIPAA-compliant eSignature integration that provides developers with a lightweight and cost-effective means of gathering information without creating security risks. We undertook the hard work to obtain HIPAA compliance in 2020 to better serve the needs of the healthcare industry with powerful workflow automation technology. Our flexible API provides access to a fully compliant and secure infrastructure that ensures sensitive health information will remain private, safe, and confidential.
To learn more about how Docubee API can keep your software HIPAA compliant, talk to one of our integration specialists today or sign up for a free trial.
