How does the law regulate the use of clinical data in biomedical research?
Biomedical research in Wisconsin is subject to a variety of laws that regulate the use of clinical data. One such law is the Health Insurance Portability and Accountability Act (HIPAA). This federal law ensures that all patient records and protected health information (PHI) remain private and secure. It requires research institutions to get permission from patients before collecting or using PHI for biomedical research. In Wisconsin, the law also specifies how data is securely stored and transmitted. All data must be encrypted to protect it from being accessed without permission. Furthermore, research institutions must comply with requirements for obtaining and documenting informed consent from patients when collecting any personal or sensitive data. In addition to HIPAA, Wisconsin has the Health Care Data Collection and Disclosure Act, which governs how patient data is used and shared. The law requires research organizations to report any unauthorized use or disclosure of PHI and imposes significant penalties for violating it. Lastly, all research organizations must provide information about patient privacy and security to employees, and may be held liable for any data breaches that occur. When researchers collect, store, use and disclose clinical data for biomedical research purposes, it is important that they adhere to all of the state and federal laws in place to protect patient privacy and ensure data security.
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