In the fast-paced world of healthcare, accessibility to patient medical information and the speed of data transmission is crucial. But proper release of medical records can be daunting, especially when it comes to following all applicable federal and state laws (including HIPAA) for the transfer of medical records.
With the ever-increasing flow of digital health information, the need to build compliant systems and processes for access and distribution of healthcare data is more important now than ever. For healthcare organizations, balancing all the regulatory updates and changes can be confusing, to say the least. So we’ve put together this handy guide to help outline some of the crucial things you should know about the compliant release of medical records. Let’s dive in!
Medical Records, the Basics.
Let’s start with Medical Records 101. Because whether you’re a seasoned medical record professional or new to the industry, a brush-up on the basics never hurts.
What is Protected Health Information (PHI)?
Protected health information (PHI) is any information that can identify someone contained within their medical record. This includes personally identifiable information (PII) like name and date of birth, as well as patient medical records, laboratory results, medical history and other crucial data points that are essential for delivering the best patient care.
The Health Insurance Portability and Accountability Act (HIPAA) is focused on ensuring that PHI is only accessible to authorized parties. There are numerous HIPAA regulations, in addition to a slew of state laws, that govern what information can be shared and who can have access to said information. But first, let’s talk about who must adhere to these regulations.
What are Covered Entities?
Covered entities must adhere to HIPAA regulations. This classification applies to any person or organization that provides medical care and transmits PHI.
There are several general types of covered entities that are responsible for the handling and protection of patient data. Healthcare providers are one of the largest categories of covered entities, including professionals such as doctors, nurses, hospitals, clinics, pharmacies and nursing homes.
Next, health plans, including but not limited to payers like health insurance companies, HMOs, employer-sponsored health plans and government health programs, such as Medicare or Medicaid, also fall into the category of covered entities. These entities act as intermediaries, receiving PHI from various sources, standardizing and validating the data, and then distributing it to the appropriate recipients. They play a crucial role in ensuring the smooth exchange of health-related information and therefore also must adhere to all regulations.
What About Business Associates?
In addition to covered entities, organizations or personnel that perform any functions on behalf of covered entities involving PHI are also subject to HIPAA regulations as business associates. This could include legal services, IT services, third-party billing services or a number of different types of business partners who receive requested information on behalf of covered entities. [Hint hint, release of information vendors like HealthMark Group are considered business associates under HIPAA]. Business associates must align with covered entities and HIPAA through business associate agreements (BAAs).
So What are Some HIPAA-Specific Rules for Disclosing Medical Records?
Now that we have a better idea of who must adhere to the regulations and with regards to what information, let’s look at some specific HIPAA rules.
Note: For the purposes of this blog, we are focusing on HIPAA regulations, but in truth, the HITECH Act of 2016 influenced changes and updates to HIPAA that we must adhere to today.
The HIPAA Privacy Rule
The HIPAA Privacy Rule establishes the standards for the protection of patients’ individual health records and other private health information, while also granting individuals rights to access and protect their personal information.
The Privacy Rule has a few key aspects, such as defining what constitutes PHI, and who qualifies as a covered entity. The Rule also sets out some specific patient rights, including a patient’s right to access his or her own PHI, request amendments to his or her records if believed to contain inaccuracies, receive an account of PHI disclosures and other various request restrictions for the use and disclosure of their information.
Additionally, The Privacy Rule sets out guidelines for obtaining a patient’s consent or authorization for the use of his or her PHI. And there is a “Minimum Necessary” principle that emphasizes the importance of patient privacy by establishing that covered entities must only distribute the least PHI possible to complete the necessary purpose. The ultimate goal of The HIPAA Privacy Rule is to establish the rights of individuals related to their patient information and put measures in place to keep their data private.
HIPAA Security Rule
The HIPAA Security Rule sets out standards for how covered entities and business associates should protect electronic forms of PHI. This rule is important because it helps to ensure the confidentiality, integrity and accessibility of ePHI.
The Security Rule requires administrative, physical and technical safeguards to prevent unauthorized access or disclosure of ePHI. Covered entities and business associates are also required to conduct risk assessments and internal audits to address any vulnerabilities in their security measures. The Security Rule calls for covered entities and business associates to have procedures in place to detect, investigate and respond to security incidents or data breaches. In the event of a breach involving unsecured or unauthorized access to ePHI, covered entities are required to notify affected individuals, HHS, and in certain cases, the media.
HIPAA & Medical Records Transfer Considerations
The Privacy and Security Rules outline key guidelines for patient data handling, storage and release. Now let’s take a look at some of the specific considerations and rules for transferring medical records.
- Patient Right of Access Rule: Patients have the right to ask for a copy of their medical records, whether they are in paper or electronic form. This rule ensures that healthcare providers give you access to your information within a reasonable time frame.
- Minimum Necessary Standard: Healthcare providers should only use or share the minimum amount of your health information needed for a specific purpose. It helps protect your privacy by limiting unnecessary access to your records.
- Consent: The Privacy Rule permits, but does not require, covered entities to obtain consent from a patient for the use or disclosure of his or her PHI for the purposes of treatment, payment or hospital operations. This consent does not involve the specific requirements of an authorization, described below.
- Authorization: Before your protected information is shared with others, your healthcare provider typically needs your permission. You might have to sign a form that allows them to release your information to specific individuals or organizations. These forms require very specific and detailed information such as the person to whom PHI can be disclosed and the period for which authorization is provided.
- Business Associate Agreements (BAAs): When healthcare providers work with third parties to perform functions involving PHI, they sign agreements to make sure these business associates also follow the rules to protect a patient’s data.
- Accounting of Disclosures: A covered entity is required to provide an individual a written record of certain disclosures of their PHI made by the covered entity, which excludes incidental disclosures such as those for treatment, payment, or hospital operations. This is called an accounting of disclosures.
- Secure Electronic Transmission: When PHI is transferred electronically, covered entities and business associates must use secure transfer methods such as encrypted email, secure file transfer protocols, or secure online portals. (Are you ever sending medical records through regular, unsecured email? That’s something you should stop immediately!)
- State Regulations: In addition to federal rules, each state may have its own laws about how medical records are handled and shared. These laws can vary, so it’s essential to know your rights based on where you live.
HIPAA Penalties and Enforcement.
The goal of HIPAA is to keep patients and their confidential information safe yet accessible. Noncompliance with HIPAA can lead to a range of significant disciplinary actions that vary based on severity. There are four tiers of penalties:
- Tier One: Unknowing violation
- Tier Two: Reasonable cause
- Tier Three: Willful neglect (corrected within 30 days)
- Tier Four: Violation due to willful neglect (not corrected within 30 days)
Fines can range from $100 per violation all the way to the maximum penalty of $1.9 million per violation. In addition to the financial repercussions, the impact of HIPAA violations can extend to loss of public trust, legal damage, lawsuits and potential harm to patients depending on the nature of the violation. Appropriate measures should be taken to both understand and comply with HIPAA requirements, as the consequences can be far-reaching.
HIPAA Rules & Medical Records Wrap Up.
The proper release of medical records and HIPAA compliance play a crucial role in safeguarding the privacy and security of PHI. As we navigate the increasingly digital landscape of healthcare, protecting patient health data has never been more crucial. The considerations and HIPAA rules we discussed are in place to ensure that a patient’s PHI remains confidential, accessible to the rightful parties and well-protected from unauthorized use and disclosure.
In a world where data is increasingly vulnerable to breaches and misuse, all covered entities must take care to follow HIPAA and any other applicable regulations when releasing medical records.
Interested in learning more about outsourcing release of information? Check out our seven reasons to outsource medical record release to learn more, or fill out the form below to talk to an expert!