The Public Readiness and Emergency Preparedness (PREP) Act is a law that helps protect against chemical, biological, radiological, and nuclear threats. Its main goal is to protect companies and people who make, distribute, and give out medical treatments during emergencies like a health crisis. This protection means they don't have to worry as much about being sued if something goes wrong. This makes it easier and faster for them to make and provide medical treatments, such as vaccines and medicines. It also allows the Secretary of the Department of Health and Human Services (HHS) the power to issue a declaration to provide immunity from liability, except in cases of willful misconduct, for claims of loss caused by these countermeasures.
How the PREP Act and HIPAA interact
While the PREP Act focuses on providing liability immunity to entities involved in developing, manufacturing, distributing, and administering medical countermeasures during emergencies, HIPAA sets standards for protecting sensitive patient health information. During a public health emergency, such as the COVID-19 pandemic, the PREP Act facilitates the rapid deployment of medical countermeasures, potentially easing certain regulatory constraints to expedite responses.
HIPAA's privacy and security rules still apply. The HHS can issue limited waivers of certain HIPAA provisions under specific conditions to support emergency response efforts, but these waivers are carefully balanced to maintain patient privacy protections. Thus, while the PREP Act accelerates medical responses in emergencies, HIPAA protects patient health information, allowing specific, context-driven relaxations of its rules.
The provisions of the PREP Act
Telehealth
The PREP Act includes special rules for telehealth, which is when health services are provided over the phone or the Internet. During a health emergency, doctors and other healthcare workers can use telehealth to treat patients in different states, even if they don't have a license in that state. This helps more people get medical care quickly and safely.
See also: PREP Act expands support of telehealth
Legal protection for medical countermeasures
The Act gives legal protection to people and companies involved in making, distributing, and giving medical treatments like vaccines and medicines during an emergency. This means they are less likely to be sued if something unexpected happens with these treatments.
Emergency preparedness
The Act helps the country prepare for emergencies by ensuring that medical supplies and treatments can be developed and distributed quickly. This is necessary for responding effectively to health crises like outbreaks of new diseases.
Public health response
The Act supports a strong public health response during emergencies. It allows for quick decisions and actions to control the spread of disease and protect public health, like getting vaccines and treatments to people who need them.
Coordination of federal and state efforts
The Act helps the federal government work with state governments during a health crisis. This coordination allows for a unified and effective response across the country.
The role of the HHS Office of the Assistant Secretary for Health (OASH)
The Office of the Assistant Secretary for Health (OASH) at the HHS enhances the nation's preparedness for public health emergencies. Specifically, OASH is responsible for issuing guidance and authorizations integral to implementing the PREP Act.
OASH's responsibilities include:
- Issuing authorizations and guidance: OASH issues specific authorizations and guidance required for carrying out the provisions of the PREP Act. These documents outline the scope of activities and the categories of professionals covered under the Act. For instance, OASH may issue guidance on how pharmacists can be involved in testing and vaccination efforts during a pandemic.
- Defining qualified persons: The PREP Act provides legal protection to certain "qualified persons" involved in the development, manufacture, testing, distribution, administration, and use of medical countermeasures. OASH specifies who qualifies as such persons, expanding the pool of healthcare providers who can respond to a public health emergency.
- Expanding healthcare services: OASH has the authority to make determinations that can significantly expand access to healthcare services during emergencies. For example, they can authorize out-of-state healthcare providers to deliver telehealth services to in-state patients, enhancing access to health services.
- Facilitating medical countermeasures: OASH is involved in the logistical aspects of distributing and administering medical countermeasures like vaccines and treatments during an emergency, ensuring that these resources are effectively utilized where they are most needed.
- Collaborating with other agencies: OASH collaborates with other HHS components and federal agencies to ensure a coordinated response to public health emergencies. This includes aligning strategies and actions with the overall goals of the PREP Act.
See also: HIPAA Compliant Email: The Definitive Guide
Amendments made under the Fourth Amendment
The amendment expands the definition of "Covered Persons" to include healthcare personnel using telehealth, allowing them to treat patients across state lines during emergencies. It also revises training requirements for pharmacists and interns, ensuring they are well-prepared to administer COVID-19 and childhood vaccinations.
The Act broadens the scope of medical countermeasures by extending liability protections to additional private distribution channels. It also clarifies the scope of legal immunity by including situations where not administering a covered countermeasure is covered under the Act's liability protections.
See also: Case study: Common data sharing practices among telehealth services
Kirsten Peremore
