Posted by Tyler Chancey, GCFA on

Tyler Chancey is a seasoned cybersecurity professional currently serving as the Director of Cyber Security at Scarlett Cybersecurity Services, With a solid foundation in Computer Software Engineering from the University of Florida, Tyler holds a repertoire of certifications that underscore his expertise. These include the prestigious Microsoft 365 Certified: Enterprise Administrator Expert and Microsoft 365 Certified: Security Administrator Associate, showcasing his mastery in Microsoft's enterprise solutions. Tyler's commitment to comprehensive security is further evidenced by his CompTIA Security+ certification, demonstrating proficiency in core cybersecurity principles. Additionally, his GIAC Certified Forensic Analyst (GCFA) credential attests to his advanced skills in forensic analysis—an invaluable asset in today's complex cybersecurity landscape. Tyler's dedication to staying at the forefront of industry standards is evident in the active pursuit and maintenance of these certifications, making him a trusted authority in the field.

healthcare cybersecurity regulations

Data is the lifeblood in the health industry. Effective risk, cybersecurity, and privacy procedures are crucial as healthcare data becomes more digital and customers expect greater access and control over their data. That’s why we must know about healthcare cybersecurity regulations to avoid losing sensitive information.

Healthcare cybersecurity regulations are the basic steps or rules that should be applied to protect ourselves from hacking agencies. More and more hospitals, clinics, and other healthcare facilities use online systems, making it easier for hackers to break in and steal information.

According to statistics, In 2021, 52% of the significant cybersecurity breaches in the United States happened in the healthcare industry. There were also 43% of incidents where staff data was attacked and 39% when patient data was attacked. Additionally, 15% of the thefts involved intellectual property and data from private companies. This stat shows how many healthcare payers and providers worldwide had chosen security standards for their strategic partnerships as of 2018.

Now, what are the primary healthcare cybersecurity regulations? What are potential solutions for protecting yourself from hackers to keep yourself safe from hacking agencies? This article will help find all possible solutions to these problems. Let's dive in.

What are Healthcare Cybersecurity Regulations?

The health industry is crucial and sensitive, so hackers find it a perfect target to attack and steal data. Cybersecurity attacks on healthcare can result in the loss of essential data that can cause the loss of crucial human life. If exposed to hackers, they can use sensitive information to get prescriptions, obtain treatment, or create false medical claims. 

These activities have the potential to create long-term and widespread damage for anyone whose information has been taken That is why it is imperative to prevent such attacks from hackers.

See Also: What Is Healthcare Cyber Security? Why is it Important?

Risk Assessments:

Healthcare cybersecurity is a growing concern for the industry. As the cost of healthcare rises and more people rely on it, cyberattacks can have serious consequences. Healthcare organizations are constantly being attacked and need many ways to defend themselves. 

To prevent their systems from being breached and protected against hackers, healthcare organizations need to be aware of their risk assessment in cybersecurity. For instance, they must be aware of common cybersecurity threats

Common Threats

There are several very common cyber threats to consider:

Before implementing a cyber security policy or plan, healthcare organizations need to do risk assessments. A risk assessment ensures that organizations are aware of what could happen if their data is compromised by a hacker and how much this could cost them.

A risk assessment will help you determine if your current security measures have any holes that need to be filled before you start implementing new policies or procedures.

Cybersecurity Healthcare Laws and Regulations

Healthcare cybersecurity regulations are a big deal, and it's important to know what they are.

The healthcare industry is crucial because it affects the lives of many people at the same time. So to keep critical data safe, there are many laws and regulations governing healthcare cybersecurity you should know about.

Health Insurance Portability and Accountability Act (HIPAA)

HIPAA was passed in 1996 to take severe steps against cybersecurity in the healthcare industry. It was primarily signed in the U.S. The main goal of HIPAA in Cyber Security is to keep data on healthcare servers from being seen by people who shouldn't be able to, like hackers. Protected health information (PHI) can only be viewed or changed by selected and covered accessors once and if HIPAA permits them.

According to the 3 Rules of HIPAA, the selected users send their requests and explain why they want to access the server, which HIPAA verifies. The users can access the servers; otherwise, they are directly blocked. HIPAA is working only in the United States now, but they look forward to expanding their services.


The penalties for non-selected users are very harsh. If any are found, HIPAA has the right to take legal action against them. Depending on the type of HIPAA violation, the fines can be anywhere from $100 to more than $50,000. The penalties of HIPAA have a calendar-year cap of around $1,500,000 dollars.

Learn more about HIPAA at


HIPAA-covered organizations must follow HITECH. In 2009, HIPAA enacted the Health Information Technologies for Economic & Clinical Health Act, which encourages the usage of electronic health records EHRs. It also added standards to protect patient privacy and security when sharing PHI electronically.

HITECH increased civil & criminal HIPAA fines while addressing patient privacy concerns. HITECH:

  • Required annual medical cybersecurity audits.
  • Developed a graded HIPAA infraction system.
  • HIPAA's Privacy & Security Rules to business contacts.
  • Enhanced Breach Notification.

Learn more about HITECH at

HHS 405

The healthcare sector and the Department of Health and Human Services created the 405(d) regulations. Section 405 (d) of the Cybersecurity Act of 2015 required HHS to set up the CSA 405(d) Task Group. The Task Force can help healthcare institutions if they adopt a "single set of voluntary, consensus-based, industry-led cybersecurity principles, practices, methods, procedures, and processes."

The culmination of this research is the Healthcare Industry Cybersecurity Practices (HICP) framework, which guides the implementation of best practices in healthcare cybersecurity. The HICP evolves with the times but always includes specific recommended procedures:

  • Electronic mail endpoint security
  • Administrating User Permissions
  • Security measures for preventing data loss
  • administration of networks
  • Protection from threats
  • Emergency procedures
  • Safety of Medical Equipment

Learn more about HHS 405 at

CFR 42

42 CFR Part 2 is a rule from the Federal Trade Commission that says how information in electronic health records should be kept safe from hacking and other unauthorized access or disclosure.

These regulations apply to any organization that handles electronic health records, including healthcare cybersecurity providers, insurers, government agencies, and any cybersecurity service that creates or uses these records in providing healthcare services.

Learn more about CFR 42 at


The Control Objective for Information & Related Technology ensures healthcare businesses properly manage cybersecurity threats. Every healthcare organization should use COBIT to detect and resolve server weaknesses.

Any company can use business COBIT internationally. COBIT 2019 simplifies integration for users. COBIT standards cover all organizations' demands to safeguard government and non-government servers and websites.

Learn more about COBIT at


HITRUST serves government and non-government institutes globally and can be customized to meet their needs. It can help with large and small servers. HITRUST's third-party blockade prevents hacker attempts and encrypts all data. It alerts users of attacks, so they may take action.

The HITRUST CSF ensures HIPAA. This certification is required by the Department of Health and Human Services & is meant to make sure that organizations are following these federal rules.

  1. The HITRUST CSF covers different domains:
  2. Your organization's security policy and procedures
  3. Your organization's information technology infrastructure
  4. Your organization's physical security measures
  5. The security of your information assets
  6. The security of your network infrastructure
  7. The authentication, authorization, and accounting mechanisms used within your environment
  8. The management of access to your network resources through user identification, authentication, authorization, and accounting technologies
  9. Your environment's ability to detect, prevent, respond to, and recover from an attack or incident occurring on your network infrastructure or data assets
  10. Data Security
  11. Remote Access Management
  12. Data Classification and Control
  13. Encryption Keys Management
  14. Audit, Monitoring & Control of Systems
  15. Security Incident Management System (SIMS) and Security Incident Reporting System (SIRS)
  16. Vulnerability Management (VM) 
  17. Penetration Testing Service Provider (PTSP) 
  18. Business Continuity Management (BCM) 

Learn more about HITRUST at


The Quality System Regulation (QSR) is a set of regulations issued by the US Food and Drug Administration (FDA) that applies to manufacturers of medical devices. These regulations are intended to ensure that medical devices are safe and effective for their intended use.

The QSR includes a requirement for manufacturers to establish a quality management system (QMS) to ensure that their devices meet the FDA's requirements and to provide a framework for continuous improvement.

The QMS includes procedures for identifying and mitigating risks associated with using the device, including cybersecurity risks. This includes implementing controls to protect against unauthorized access, use, disclosure, disruption, modification, or destruction of device data and information.

Manufacturers of medical devices are required to comply with the QSR, which includes conducting a risk analysis and implementing a cybersecurity management program as part of their QMS. The QSR also requires manufacturers to report certain cybersecurity incidents to the FDA as soon as possible and take appropriate corrective and preventive actions.

QSR Resources

Some specific resources that may be helpful include:

  • Quality System Regulation: Medical Device Good Manufacturing Practice" (21 CFR Part 820): This is the regulation that manufacturers must follow, which lays out the requirements. 
  • Guidance for Industry and FDA Staff: Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. This document guides on developing and implementing a cybersecurity incident response plan specific to the medical device industry.
  • Medical Device Cybersecurity: FDA Safety Communication": This safety communication provides recommendations for manufacturers, hospitals, and healthcare providers on managing cybersecurity risks associated with medical devices
  • FDA's Cybersecurity Webpage. This webpage provides a collection of resources on cybersecurity, including guidance documents, information on reporting cybersecurity incidents, and links to other relevant organizations.

Additionally, professional organizations and industry groups provide guidance and resources on the QSR and cybersecurity in healthcare, such as the Health Information Trust Alliance (HITRUST) and the Medical Device Innovation, Safety, and Security Consortium (MDISS).

Learn more about QSR at

NIST: The National Institute of Standards and Technology

A framework of standards, guidelines, and best practices for managing cybersecurity risks in critical infrastructure was developed by the National Institute of Standards and Technology (NIST).

The NIST framework is designed to help organizations in critical infrastructure sectors, such as energy, finance, and healthcare, to understand and manage their cybersecurity risks in a structured and systematic way. The framework comprises five core functions: Identity, Protect, Detect, Respond, and Recover

It provides a common language and framework for organizations to use when assessing and improving their cybersecurity capabilities. The framework is voluntary, and organizations can choose which parts to implement based on their specific needs and risk profile.

Compliance with NIST is mandatory?

Compliance with the National Institute of Standards and Technology (NIST) Framework for Improving Critical Infrastructure Cybersecurity is not mandatory, but it is widely adopted and recommended as a best practice for managing cybersecurity risks.

Many organizations in critical infrastructure sectors must comply with regulations that mandate using the NIST framework or similar standards. For example, the Cybersecurity Information Sharing Act (CISA) of 2015 requires specific critical infrastructure organizations to adopt the NIST framework as part of their cybersecurity risk management programs.

Additionally, many organizations, not only from critical sectors but from various industries, voluntarily adopt the NIST framework to improve their cybersecurity posture, manage the risk and demonstrate due diligence to the public, customers, and stakeholders.

However, it is essential to note that simply complying with the NIST framework does not guarantee complete protection against cyber threats, it is a continuous process of risk management and must be regularly updated and reviewed to adapt to the new threat landscape.

Best Possible Practices to Prevent Hacking

The doctors and the staff should be provided with the proper certificates to deal with medical equipment that can be hacked. Also, IT experts who work in the health sector should have the right kind of training. IT professionals in the healthcare industry should take a proper test and be granted a license to work and deal with cyber work.

Healthcare departments also require a more online-based system, which increases the system's risk. Most of the time, IT specialists discover problems after they have already occurred. So, the system should be set up with the right antivirus software so that the problem can be found quickly and the proper steps can be taken to avoid a significant loss.

It’s best to get a consultancy from professional cybersecurity providers. You can also subscribe to a 3rd party cybersecurity service. Many firms also provide outsourced cybersecurity, which can be a good option. 

Data leaks not only make it easier for hackers to steal data, but they can also make hackers cut off access to their servers for healthcare IT experts. An effective data leak detector can be made that can be very helpful in detecting if any data leaks happen on the server.

Learn more about NIST at


The Center for Internet Security (CIS) Critical Security Controls 

The Center for Internet Security (CIS) Critical Security Controls are a set of 20 security controls that organizations can use to improve their cybersecurity posture. These controls are intended to address the most common and critical cyber threats and are based on the experience of experts from government, industry, and academia.

The 20 CIS Critical Security Controls are:

  1. Inventory of Authorized and Unauthorized Devices
  2. Inventory of Authorized and Unauthorized Software
  3. Secure Configurations for Hardware and Software on Mobile Devices, Laptops, Workstations, and Servers
  4. Continuous Vulnerability Management
  5. Controlled Use of Administrative Privileges
  6. Maintenance, Monitoring, and Analysis of Audit Logs
  7. Email and Web Browser Protections
  8. Malware Defenses
  9. Limitations and Control of Network Ports, Protocols, and Services
  10. Data Recovery Capability
  11. Secure Configurations for Network Devices such as Firewalls, Routers, and Switches
  12. Boundary Defense
  13. Data Protection
  14. Controlled Access Based on the Need to Know
  15. Wireless Access Control
  16. Account Monitoring and Control
  17. Security Skills Assessment and Appropriate Training to Fill Gaps
  18. Application Software Security
  19. Incident Response and Management
  20. Penetration Tests and Red Team Exercises

These controls are particularly relevant to the healthcare sector as they contain sensitive personally identifiable information (PII) and protected health information (PHI), which are highly valuable to cyber-criminals. Adopting these controls can help healthcare organizations to protect against cyber threats and ensure compliance with regulations such as HIPAA. You can also explore hiring a HIPAA Compliance Officer or HIPAA Compliance Consultant to your organization.

Learn more about The Center for Internet Security (CIS) Critical Security Controls at

ISO/IEC 27001

ISO/IEC 27001 is an international standard that provides a framework for an information security management system (ISMS). It is designed to help organizations of any size or type to protect their information assets, such as financial data, personal information, and confidential business information.

The standard is based on a systematic approach to managing sensitive company information so that it remains secure. It includes the following components:

  • A policy for information security that sets out the organization's overall intentions and direction
  • Procedures that describe how the policy is put into practice
  • Checking that the procedures are working as intended
  • Reviewing and improving the ISMS

It is based on the Plan-Do-Check-Act (PDCA) cycle, a continuous improvement process. This standard defines the management system and the requirements for its implementation and provides a common language for information security management.

ISO/IEC 27001 certification formally recognizes an organization's compliance with the standard. It is achieved through a certification body's independent assessment and audit process. Organizations certified to ISO/IEC 27001 can demonstrate to customers, suppliers, and other stakeholders that they have a robust and effective information security management system.

Learn more about ISO/IEC 27001 at


The Payment Card Industry Security Standards Council is a non-profit group that sets information security guidelines for the credit card industry and shares them with the public. The PCI DSS is often called "the PCI framework" or "the PCI standard."

The PCI DSS aims to help organizations deal with the risk of data breaches, whether because of an employee's mistake or because someone is trying to steal information. The PCI DSS is meant to protect cardholder and authentication data by ensuring that organizations have policies and procedures that help them follow federal laws and regulations and other standards set by the industry.

According to PCI DSS, healthcare organizations are responsible for maintaining a secure environment for systems and data used to process health insurance claims. This includes:

  • Maintaining a complete and accurate list of all sensitive cardholder data stored on the organization's network.
  • Maintaining up-to-date backups of all cardholder data stored on the organization's network.
  • Implementing strong access controls, including least privilege principles, account management and authorization, role-based access control (RBAC), and least privilege auditing;
  • Ensuring that all information technology resources are properly segregated from each other, physically separated from patient care areas, and protected from unauthorized access.
  • Using encryption technologies when appropriate.
  • Regularly testing security controls and procedures against threats or vulnerabilities that security assessments or benchmarks have identified.

PCI DSS has three primary components

  • Physical controls: Locking doors and installing hardware security modules prevent access to networked devices.
  • Logical controls include monitoring log files and restricting access to certain applications or web pages.
  • Operational controls include policies regarding when employees can work on the network, what they can do while working on it, and how long they have access before changing their password.

Learn more about PCI DSS at

GDPR Data Security Regulations in the EU

The European Union General Data Retention Regulation GDPR is the most recent regulation addressing privacy issues in healthcare settings. It came into effect on May 25, 2018, following a six-year process of negotiations between EU member countries. The GDPR applies to all organizations within the EU that handle the personal data of EU residents.

Under this law, companies must tell the government within 72 hours of finding a data breach or loss of personal information. It is also necessary for them to let users know what sort of information they will receive, how it will be used, and under what circumstances it will be shared. Companies must also have the right policies and procedures to meet GDPR requirements.

Learn more about GDPR Data Security Regulations at

What does it take to maintain cybersecurity compliance in the healthcare sector?

It takes a lot of work, and it's not just about being an outsider. If you're a business owner or employee, you must keep up with everything from properly stored data to updated software and passwords. If you're a patient, you need to know that your information is safe from hackers and that no one can access your medical records without authorization.

We'll look at how to keep cybersecurity compliance in the healthcare sector, but first, let's talk about what "compliance" means in this context. When we say "compliance," we mean following all laws and regulations related to your company's operation, whether federal or state laws or industry standards set by organizations like HIPAA or PCI-DSS.

You also have to ensure your security policies are current and up-to-date, so if you've got any old ones lying around on your drive, get rid of them! Your security policies should be regularly reviewed by an outside party, so everyone knows where they stand when protecting themselves from cyberattacks.

The first step in maintaining cybersecurity compliance is implementing a strong authentication strategy. A strong authentication strategy involves using multi-factor authentication (MFA) at all access points within your network so that only authorized users can log on. MFA helps prevent unauthorized access, which can lead to data breaches and identity theft.

Current trends in healthcare cybersecurity regulations & changes

One of the most recent changes to healthcare cybersecurity rules is that all health plans and healthcare providers now have to follow the HIPAA security standards. All employees now have to go through background checks and, whenever possible, get two-factor authentication. The Healthcare Information & Management Systems Society  has called the need for two-factor authentication "an important step forward."

Also, the Centers for Medicare & Medicaid Services (CMS) has said they will add more rules about HIPAA compliance over the next few months. It is expected that these changes will make a big difference in the future security of the healthcare industry.

Security Controls in Healthcare Cybersecurity

Healthcare cybersecurity regulations are a great way to protect your health data from cyber threats. Both basic and advanced safety controls must be implemented to ensure the security of healthcare facilities. 

Basic security controls include

Advanced Security Controls Include

Best Possible Practices to Prevent Hacking

The doctors and the staff should be provided with the proper certificates to deal with medical equipment that can be hacked. Also, IT experts who work in the health sector should have the right kind of training. IT professionals in the healthcare industry should take a proper test and be granted a license to work and deal with cyber work.

Healthcare departments also require a more online-based system, which increases the system's risk. Most of the time, IT specialists discover problems after they have already occurred. So, the system should be set up with the right antivirus software so that the problem can be found quickly and the proper steps can be taken to avoid a significant loss.

It’s best to get a consultancy from professional cybersecurity providers. You can also subscribe to a 3rd party cybersecurity service. Many firms provide outsourced cybersecurity as well which can be a good option. 

Data leaks not only make it easier for hackers to steal data, but they can also make hackers cut off access to their servers for healthcare IT experts. An effective data leak detector can be made that can be very helpful in detecting if any data leaks happen on the server.

Final Thoughts

The government and non-government sectors in healthcare focus more on preventing hacking in healthcare departments than they did in the past. Some of them have already started investing more in healthcare cybersecurity solutions. But many still need to learn how dangerous it can be not to make your healthcare servers safe.

These days, hackers grab our data without telling us. Thus, good teams should monitor attacks and threats. Risking the healthcare sector means risking patient lives.

In the health department, the servers are as important as any other task that needs our attention. If small pieces of information are lost, it can significantly impact the health of many people who rely on the public and private health sectors. Therefore, their responsibility is to ensure the privacy and security of their users' data.

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