How Can HIPAA Waivers Help Your Medical Research?
Medical studies need accurate data to be credible. To conduct a study, you need at least some funding, participants, a researcher without biases, and, of course, accurate data. But what happens to studies when one of these basic elements is missing? Well, your entire study can become unreliable and even misleading.
Suspicious data can ruin a study’s credibility, rendering all the effort meaningless. Some researchers prefer to collect medical data from patient trials and records. They need permission to use a patient’s PHI (personal health information) to do that legally. But how can you get permission to use somebody’s PHI? With a HIPAA waiver, of course! Let’s see what that is.
Use HIPAA Waivers for Your Research
First, let’s go over what a HIPAA waiver is. It is a document that allows doctors, researchers, and other covered organizations to use personal health information for non-healthcare pursuits. These purposes include studies and marketing.
HIPAA waivers allow you to use data coming from patients even without their express agreement. However, they won’t give you unlimited access to someone’s personal information. This happens because the waiver allows patients to control how their data is used.
HIPAA waivers must allow patients to specify what personal information can be disclosed, to whom, and for what purpose. A waiver usually includes restrictions such as:
- What personal health information can be used
- What the information can be used for
- Who can disclose and use personal health information
- How long the personal health information can be used for
- Who is authorized to see the information
To stay HIPAA-friendly when collecting data, you should add the abovementioned rules and restrictions to your waivers. Once the participants sign them, you will be able to legally use their PHI.
When Is the HIPAA Waiver Necessary?
A HIPAA waiver of authorization is mandatory only if the study participant lives in the United States of America. HIPAA only applies to the US. Study participants from other countries don’t have to adhere to HIPAA protocols. They must, instead, adhere to GDPR, where consent conditions differ depending on the context of the health research in question.
Other situations in which personal health information can be used without a HIPAA waiver form include providing open public medical records and existing research records. These types of records are helpful when researchers can’t acquire patient consent.
However, it is possible to need more data for your research when going this route. There’s one more thing you can do to get the data you need: ask an institutional review board. When it’s impossible to ask patients to sign a waiver, you can put together a proposed study and have it reviewed by an institutional review board or a privacy board. If an entity determines that your study qualifies to protect PHI, they may grant a waiver of authorization.
A waiver of authorization from an institutional review board is valuable to maintain legal compliance when patient HIPAA waivers are unavailable.
How Do You Use HIPAA Waivers?
Every waiver of authorization is different, just like every study. They all have individual conditions and variables. You must follow specific study directions based on institutional review board waivers or patient form completion.
Let’s review some essential approaches for using HIPAA waivers:
- Make sure you comprehend the terms of the waiver and understand what actions it allows you to take. If the patient filling out the form places limits on how you can use his data, you must respect these boundaries.
- When you cannot receive a waiver of authorization from a competent review board, ensure you have signed waivers from every study participant. Have them sign it before you begin the study to cover your bases.
- Let’s say you don’t have the option of using patient-signed waivers. Then, you must contact an institutional review board or a privacy board and obtain a waiver of authorization. The process may limit how you can use the data.
- Use safety measures to protect PHI. You must have security features to store and protect personal health information and restrict access to unauthorized personnel.
- Report data breaches as soon as possible. Immediately take steps to mitigate the breach and protect the data.
There’s a chance you need to use personal health information to do your work, be it for research or other purposes. With the proper authorization, you can stay compliant and ethical while doing your analysis.
Conclusion
As you can see, accessing personal health information for research is not impossible. You can conduct your studies while protecting patient information with the right HIPAA waiver forms and following the proper regulations.
Use 123FormBuilder to build the ideal HIPAA waiver form for your study, research, or other avenues. We have secure online forms with HIPAA and GDPR compliance that allow you to collect the patient consent required for your research. Get started today; it’s FREE!
