The relationship between HIPAA, HITECH, and electronic health records is an extremely important one. The Health Insurance Portability and Accountability Act (HIPAA) was first enacted in 1996 with the intention of protecting sensitive patient health information. As the digital age emerged, the Health Information Technology for Economic and Clinical Health (HITECH) Act was passed in 2009 as a way to enable the transmission of protected health information (PHI) electronically.
These acts have had a mutual impact on each other, transforming and improving security rules for healthcare providers and companies in the MedTech industry. But how deep does the relationship go? Moreover, how do these acts affect the way MedTech applications are developed in terms of electronic data storage and sharing?
In this post, we’ll explore how the HIPAA and HITECH acts have set standards for electronic patient health data transmission and how they’ve helped to shape the protocols that must be followed when developing MedTech apps.
What Is the Relationship Between HITECH, HIPAA, and Electronic Health or Medical Records?
The HIPAA-HITECH relationship is a strong one, especially with regards to Title II of HIPAA, which outlines the security rules and regulations concerning patient privacy and the transmission of protected health information, such as a patient’s social security number, address, underlying conditions, previous medical treatments, medications, and so on. Title II of HIPAA has five rules, many of which have been impacted by the HITECH Act. Let’s explore these further.
HIPAA Privacy Rule and HITECH Act Implications
The HIPAA Privacy Rule governs the type of patient medical information that can be shared and with whom. As far as the PHI that can be disclosed, the Privacy Rule restricts the sharing of private medical information to the following:
- Disclosure of past, present, and future medical information about a patient;
- Sharing medical information for the purposes of providing treatment to a patient and obtaining approval from insurance providers;
- Public interest, which can include notifying organizations, such as local healthcare officials, the Centers for Disease Control and Prevention (CDC), or the World Health Organization (WHO) of information that can help identify and prevent the spread of a disease or virus, such as during the COVID-19 pandemic;
- Medical research, case studies, and the development of medical treatments, such as the COVID-19 vaccine.
- Incidental circumstances, such as another person overhearing a conversation about a patient’s condition or treatment options, so long as the patient’s identity is kept confidential.
The most important thing to remember, however, is the fact that none of this information can be shared without the patient giving explicit consent, especially if their name will be used. Sharing general data regarding a condition or treatment is not considered to be a violation of HIPAA’s Privacy Rule.
With respect to the HITECH Act, the HIPAA Privacy Rule was enforced to ensure that the disclosure of personal patient information applied also to the sharing of data via electronic means, such as through email or via web or mobile apps. Prior to the introduction of MedTech applications, patient data was shared by phone, fax, or in person. The HITECH Act helped to modify HIPAA’s regulations so that privacy rules would also extend to these apps.
Patients using these apps can choose what kind of information can be shared by updating the privacy settings on their apps. Businesses who created these apps must also be fully transparent with users about privacy laws so that users are aware of the fact that they have a choice in what they can disclose and to whom. Additionally, businesses must disclose the extent of the patient’s data they will be sharing.
HIPAA Security Rule and HITECH Safety Protocols
HIPAA’s Security Rule is perhaps the one most impacted by the HITECH Act. The Security Rule specifically governs the sharing of electronic PHI and outlines the rules regarding the e-sharing of a patient’s personal health records, should a healthcare provider or insurance company choose to do so. The Security Rule protects the PHI that is being shared, ensuring that the patient provided consent, that the patient’s confidentiality is not breached in any way, that only authorized persons are able to access the patient’s records, and that the records are not altered or destroyed.
Furthermore, the Security Rule calls for all entities that have the authority to access and/or transmit patient information to implement security measures to prevent unauthorized access to said records. This can be accomplished by:
- Outlining strict protocols regarding the transmission and maintenance of patient records;
- Ensuring that any and all personnel that have access to patient records are properly trained on how to safely discuss and transmit patient data;
- Encrypting patient files when they are electronically transmitted;
- Safeguarding computers and electronic files to reduce and prevent hacks, among others.
The HITECH Act strengthened HIPAA Security Rules regarding the transmission of electronic data to ensure that healthcare providers, insurance companies, and MedTech apps abide by strict safety protocols. Health providers and insurance companies should implement extremely high security protocols to prevent patient records from being accessed by unauthorized persons, such as establishing cybersecurity measures, encrypting file transfers, two-factor authentication methods, and other security measures. App creators should ensure that their applications include HIPAA compliant software and provide authentication forms so healthcare providers can be properly vetted.
HIPAA Breach Notification Rule
Even when strict privacy and security rules are in place, violations affecting patient confidentiality and data can still occur. The HIPAA Breach Notification Rule requires that entities that are authorized to handle, manage, and transmit patient medical records notify individuals and other vested parties when private patient information has been viewed, acquired, or altered by unauthorized parties, as well as the type of breach that occurred. The notices should be sent by mail first and then via email if the parties have opted in to email notifications.
Ensuring Your MedTech App Is HIPAA/HITECH Compliant
Failing to abide by HIPAA/HITECH Act protocols and breach notification rules can leave healthcare providers, insurance companies, and MedTech businesses looking at paying thousands to millions in fees. The specific penalty is determined by individual HIPAA and HITECH violation tiers. That being said, any company that has access to electronic patient records, has a MedTech app, or would like to build a new application should consult with an app development company that has experience successfully creating apps that adhere to the compliance guidelines set forth by these acts.
