Final answer:
The HHS has issued guidance to ensure the protection of ePHI handled by devices and tools, adhering to HIPAA regulations and other directives like those overseen by the CDRH.
Step-by-step explanation:
To address the growing concern for the use of devices and tools that enable access to or use of ePHI outside the CE's physical purview, the Health and Human Services (HHS) issued guidance based on existing regulations like the Health Insurance Portability and Accountability Act (HIPAA). HIPAA sets standards for the protection of patient information requiring confidentiality of patient records. With the evolution of technology and the increase in mobile and other electronic devices handling personal health information, the need to ensure security and compliance with regulations like HIPAA is paramount. This also includes directives from entities such as the Center for Devices and Radiological Health (CDRH), which is responsible for ensuring the safety and effectiveness of medical devices in use.