Cyber Security for Medical Devices and Hospital Networks

2021 Alliance sponsor feature article courtesy of the Sentinel Risk Advisors

Many medical devices contain configurable embedded computer systems that can be vulnerable to cyber-security breaches. In addition, as medical devices are increasingly interconnected via the Internet, hospital networks, other medical devices or smartphones, there is an increased risk of cyber-security breaches, which could affect how a medical device operates.

The Food and Drug Administration (FDA) has recently become aware of cyber-security vulnerabilities and incidents that could directly impact medical devices or hospital network operations, such as the following:

• Network-connected/configured medical devices infected or disabled by malware.
• The presence of malware on hospital computers, smartphones and tablets, targeting mobile devices using wireless technology to access patient data, monitoring systems and implanted patient devices.
• Uncontrolled distribution of passwords, disabled passwords, hard-coded passwords for software intended for privileged device access (e.g., to administrative, technical and maintenance personnel).
• Failure to provide timely security software updates and patches to medical devices and networks and to address related vulnerabilities in older medical device models (legacy devices).
• Security vulnerabilities in off-the-shelf software designed to prevent unauthorized device or network access, such as plain-text or no authentication, hard-coded passwords, documented service accounts in service manuals and poor coding/SQL injection.

The FDA has been working closely with other federal agencies and manufacturers to identify, communicate and mitigate vulnerabilities and incidents as they are identified.

FDA Recommendations/Actions

The FDA has a number of recommendations to mitigate the risks that technology may pose to health care organizations.

For all device manufacturers:

Manufacturers are responsible for remaining vigilant about identifying risks and hazards associated with their medical devices, including risks related to cyber security, and are responsible for putting appropriate mitigations in place to address patient safety and ensure proper device performance.

The FDA expects medical device manufacturers to take appropriate steps to limit the opportunities for unauthorized access to medical devices. Specifically, it is recommended that manufacturers review their cyber-security practices and policies to ensure that appropriate safeguards are in place to prevent unauthorized access or modification to their medical devices or compromise the security of the hospital network that may be connected to the device. The extent to which security controls are needed will depend on the medical device, its environment of use, the type and probability of the risks to which it is exposed, and the probable risks to patients from a security breach.

In evaluating your device, consider doing the following:

• Take steps to limit unauthorized device access to trusted users only, particularly for those devices that are life-sustaining or could be directly connected to hospital networks.
• Appropriate security controls may include user authentication, such as user ID and password, smartcard, or biometrics; strengthening password protection by avoiding hard-coded passwords and limiting public access to passwords used for technical device access; physical locks; card readers; and guards.
• Protect individual components from exploitation and develop strategies for active security protection appropriate for the device’s use environment. Such strategies should include timely deployment of routine, validated security patches and methods to restrict software or firmware updates to authenticated code. The FDA typically does not need to review or approve medical device software changes made solely to strengthen cyber security.
• Use design approaches that maintain a device’s critical functionality, even when security has been compromised, known as “fail-safe modes.”
• Provide methods for retention and recovery after an incident where security has been compromised.
• Cyber-security incidents are increasingly likely and manufacturers should consider incident response plans that address the possibility of degraded operation and efficient restoration and recovery.

For health care facilities:

The FDA recommends that you take steps to evaluate your network security and protect your hospital system. In evaluating network security, hospitals and health care facilities should consider doing the following:

• Restricting unauthorized access to the network and networked medical devices.
• Making certain that appropriate antivirus software and firewalls are up to date.
• Monitoring network activity for unauthorized use.
• Protecting individual network components through routine and periodic evaluation, including updating security patches and disabling all unnecessary ports and services.
• Contacting the specific device manufacturer if you think you may have a cyber-security problem related to a medical device.
• If you are unable to determine the manufacturer or cannot contact the manufacturer, the FDA may be able to assist in vulnerability reporting and resolution.
• Developing and evaluating strategies to maintain critical functionality during adverse conditions

Reporting Problems to the FDA

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect that a cyber-security event has impacted the performance of a medical device or has impacted a hospital network system, file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

For guidance on how to keep your healthcare facility safe and secure from cyber threats, contact Amelia Bernstein, Senior Director of Specialty Lines at Sentinel Risk Advisors.

Amelia Bernstein’s legal background allows her to provide clients with complex needs with specialty lines of coverage. As the Senior Director of Specialty Lines and a Partner in the firm, Amelia oversees a broad range of client accounts, including all of Sentinel’s professional, executive and cyber liability insurance clients. She has a proven background of providing clients with risk management solutions they were once told were impossible to achieve.

The 411 on HITECH and HIPAA IT Compliance

By Judi Grassi

2020 Alliance sponsor feature article courtesy of Carolinas IT: A Logically Company

Most group practices and clinics have adopted the Electronic Health Record (EHR). If you’re one of these organizations, you know how imperative it is to keep your Electronic Protected Health Information (EPHI) safe. Both HIPAA and the HITECH Act lay out very specific requirements about data protection and regardless of your size, you are required to keep your Protected Health Information (PHI) data secure. This is especially imperative if your organization electronically transmits health information for financial or administrative reasons, such as claims processing, benefit eligibility, referral authorization requests, and other transactions defined under the HIPAA Transactions Rule.

Three Areas of HIPAA IT Compliance

HIPAA IT compliance is the responsibility of every administrative and clinical staff member in your organization. To make compliance requirements easier to digest, HHS established three areas of HIPAA IT compliance.

1. 1. Administrative — These measures ensure the integrity of patient data and accessibility only to authorized parties. It requires HCOs to:
      • Implement a security management process that identifies potential risks to EPHI and appropriate security measures to reduce risks and vulnerabilities.
      • Designate a security official who is responsible for ensuring HIPAA and HITECH compliance.
      • Identify who has authorized access to EPHI.
      • Provide appropriate security training to employees and follow through with appropriate sanctions against any employee who violates security policies.
      • Perform a periodic assessment to assess the effectiveness of your security policies.
   2. Physical — These measures ensure the security of facilities and devices that contain EPHI. It provides HCOs to:
      • Limit physical access to their facilities to authorized personnel only and protect against physical intrusion.
      • Ensure secure access to workstations and electronic media. This includes procedures for the transfer, removal, disposal, and re-use of electronic media to ensure appropriate protection of EPHI.
   3. Technical — These measures ensure that your IT systems and networks are secure from data breaches and unauthorized access. It requires HCOs to:
      • Protect their IT systems against digital intrusion and ensure that EPHI is transmitted over a secure network.
      • Only allow authorized individuals to access EPHI and ensure IT systems provide an audit trail to track EPHI access.
      • Ensure EPHI is not improperly or erroneously altered or destroyed.

HITECH Compliance

The HITECH Act of 2009 shored up these privacy and security provisions:

• HCOs, business associates, and service providers are all responsible for the security of EPHI.
• HCOs must promptly notify affected individuals whose PHI was compromised.
• HCOs must report any security breach that affects more than 500 individuals to the HHS Secretary.
• HCO business associates must notify the HCO of any breach at or by the business associate.
• Breaches affecting fewer than 500 individuals must be reported to the HHS Secretary on an annual basis.

How to Comply with HIPAA and HITECH Technical Measures
Whether you are a hospital, clinic, medical practice, HCO business associate, or HCO service provider, you will need to address the following in order to comply with HIPAA and HITECH technical measures.

• Develop policies and procedures for data backup and recovery.
• Back up your data on a regular, frequent basis and ensure you can retrieve exact copies of EPHI and restore any lost data. Follow the 3-2-1 backup rule: 3 copies of your data across 2 media with 1 copy stored offsite.
• Establish acceptable but aggressive Recover Time Objectives (RTOs) and Recovery Point Objectives (RPOs) and develop a disaster recovery plan that meets these objectives.
• Periodically test your disaster recovery plan to be sure it works before a real disaster happens.
• Perform an annual risk assessment to determine whether your systems and data are a security risk and how vulnerable you are to attack.
• Develop a data breach response plan to identify who is responsible for what when a breach occurs, how to communicate with individuals whose PHI was compromised, how to handle the media, minimize further data loss, and remediate the breach.
• Encrypt EPHI data in transit and at rest.
• Ensure HCO business associates and service providers meet HIPAA and HITECH security requirements.

Noncompliance Fines
If you are found in noncompliance with HIPAA and HITECH regulations, it can cost you. Fines are based on the violation category or level of perceived negligence and can range from $100 to $50,000 per violation, with a maximum penalty of $1.5 million per year for each violation (see Figure 1).

Figure 1

If you are breached and fined, your organization is listed on the HHS Office for Civil Rights (OCR) Breach Portal and “Wall of Shame” if the breach involves 500 or more individuals. If your organization has a breach of this magnitude, the name of your HCO will be permanently listed.

Final Thoughts

HCOs have two choices when it comes to HIPAA IT compliance requirements: DIY (Do It Yourself) or hire an IT Managed Service Provider (MSP). Whether you are a large or small HCO, you may find that you have limited IT resources and/or skills in-house to ensure your EPHI is private and secure. Therefore, many HCOs look to HIPAA-compliant MSPs to back up their systems, ensure the privacy of EPHI, and provide the best protection from security breaches.

Figure 1: Categories of Violations and Respective Penalty Amounts Available. Source: https://www.federalregister.gov/documents/2013/01/25/2013-01073/modifications-to-the-hipaa-privacy-security-enforcement-and-breach-notification-rules-under-the#h-95