In today’s healthcare landscape, the complexity and magnitude of cyber threats have highlighted the need for robust regulations to protect patients and organizations. However, understanding and complying with these regulations can be challenging, emphasizing the importance of gaining a solid grasp of the regulatory landscape.
One misconception that persists is the belief that the Health Insurance Portability and Accountability Act (HIPAA) covers all health information. In reality, HIPAA’s scope is limited to health plans, healthcare clearinghouses, and healthcare providers engaged in standard transactions, along with their business associates.
Patients may also assume that HIPAA safeguards their health data regardless of the entity collecting it or its storage location. However, only covered entities and their business associates are subject to HIPAA regulations.
Additionally, confusion prevails among healthcare providers regarding when they can release information and when they cannot. Even though HIPAA has been in effect for over 20 years, there remains uncertainty among these individuals.
Another area of confusion lies in the role of the Federal Trade Commission (FTC) in safeguarding health data held by entities not covered by HIPAA, particularly in the digital health space. With only a small number of digital health apps falling under HIPAA jurisdiction, the FTC plays a significant role in this arena.
Alongside the FTC’s Health Breach Notification Rule, other regulations impacting health data include substance use disorder regulations, state laws, and international laws. Compliance and breach response can be challenging due to the multitude of regulatory elements at play.
Elizabeth Hodge, Partner in the Healthcare Practice Group at Akerman, emphasizes the importance of maintaining a thorough incident response plan that considers both compliance activities and operational disruptions. Organizations should periodically test their response plans, ensure offline backups that can be recovered effectively, invest in various safeguards, and provide cybersecurity training to their workforce.
Frequently Asked Questions (FAQ)
What does HIPAA cover?
HIPAA covers health plans, healthcare clearinghouses, and healthcare providers engaged in standard transactions, along with their business associates.
Does HIPAA protect all health information?
No, HIPAA only applies to covered entities and their business associates, safeguarding health data within the context outlined by the regulations.
What is the role of the Federal Trade Commission (FTC) in protecting health data?
The FTC plays a significant role in protecting health data held by entities not covered by HIPAA, particularly in the digital health space where few apps are subject to HIPAA jurisdiction.
What are some challenges in maintaining compliance with health data regulations?
Some challenges include understanding which breach notification laws apply, as entities may be subject to HIPAA or the FTC’s jurisdiction. Additionally, all 50 states have breach notification laws, some of which include health information, and there is a growing rollout of consumer privacy laws at the state level.
How can organizations navigate compliance and data breach response?
Organizations should stay updated on guidance from government agencies, develop and test incident response plans, keep backups offline and regularly test their recovery capabilities, invest in various safeguards, and provide ongoing training and education on cyber threats to their workforce.
Source: Healthcare Strategies – (URL)