Why is Compliance Important in Healthcare?

Posted by Steve Alder

Compliance is important in healthcare because complying with the regulations that govern the healthcare industry can help avoid legal risks and penalties for non-compliance, protect the privacy and security of individually identifiable health information, and improve the quality and safety of patient care. In addition, demonstrating compliance with healthcare regulations can enhance the reputation of – and trust in – healthcare organizations and healthcare professionals.

Compliance in healthcare can mean different things to different people. For healthcare organizations, compliance can mean following the rules and regulations that apply to their operations. Depending on the nature of their operations, this can mean complying with (for example) HIPAA, OSHA, the Joint Commission standards, and the conditions of participation in Medicare. Most organizations also have to comply with local regulations relating to public health and emergency preparedness.

For members of organizations’ workforces, compliance in healthcare most often means complying with the organization’s policies and procedures. Although there are circumstances in which individuals can be personally liable for regulatory violations, in most cases the penalty for not complying with an organization’s policies and procedures is determined by the content of the organization’s sanctions policy (i.e., verbal/written warning, suspension, termination, etc.).

Compliance in healthcare is also important to patients. Not only are patients more likely to disclose confidential information about themselves when they feel the information will remain confidential – which can result in more accurate diagnoses and treatment plans, and better patient outcomes – but they are more likely to comply with treatment plans and therapies – resulting in less patient testing, fewer avoidable hospital visits, lower readmissions, and reduced costs for healthcare organizations.

However, although compliance in healthcare can means different things to different people, the benefits of compliance are connected. When a healthcare organization complies with regulations, it provides a safer, better educated workforce that can deliver a better standard of care to patients. When workforce members comply with organizational policies and procedures, it can reduce costs and better protect patient data, and when patients comply with their treatment plans and therapies, workforce morale and retention increases, further reducing costs for healthcare organizations.

Compliance for Healthcare Organizations

Compliance for healthcare organizations is complicated by the number of rules and regulations they have to comply with, the way regulations can overlap, and the frequency with which they can change. In larger organizations, compliance teams may be required to manage the volume of rules and regulations and the frequency with which they can change, while HR, legal, and IT teams may also be involved in developing policies and procedures and monitoring compliance with them.

Compliance for healthcare organizations is not only a legal obligation, but also a moral and ethical one. Healthcare organizations have a duty to uphold the standards of their profession and to act in the best interests of their patients. Complying with the applicable rules and regulations helps healthcare organizations deliver high-quality care that meets the needs and expectations of their patients, as well as the requirements of the law in order to avoid legal risks and penalties.

Why is Workforce Compliance Important in Healthcare?

Workforce compliance is important in healthcare because members of the workforce are the public face of healthcare organizations. By demonstrating an understanding of regulatory compliance and complying with the policies and procedures implemented by the healthcare organization, members of the workforce can build trust between patients and healthcare providers – which, not only benefits patients, but which can also result in increased workplace morale and job satisfaction.

Failing to comply with organizational policies can be professionally detrimental to workforce members. While minor violations of organizational policies and procedures might only result in a verbal warning or compliance retraining, serious or repeated violations can lead to sanctions that remain permanently on an employment record – or, in the worst cases, lead to suspension, termination of contract, and loss of license to practice.

Why is Patient Compliance Important in Healthcare?

Patient compliance, also known as medication adherence, is the degree to which patients follow the instructions of their healthcare providers. It is an important metric in the effectiveness of treatments, the prevention of complications, and the improvement of patient outcomes. However, patient compliance in healthcare is surprisingly low. According to the World Health Organization, only about 50% of patients in developed countries adhere to their prescribed therapies.

Improving patient compliance in healthcare requires a multifaceted approach that involves educating and counseling patients about their condition and treatment options, providing them with clear and simple instructions and reminders, and addressing their concerns and preferences. However, in order for this approach to work, it is necessary for patients to trust their healthcare providers – something that can be accomplished by organizational and workforce compliance in healthcare.

Improving Compliance in Healthcare

Compliance is not a one-time event, but an ongoing process that requires constant monitoring, evaluation, and improvement. Healthcare organizations need to have effective compliance programs that include policies, procedures, training, auditing, and reporting. Sanctions also need to be applied fairly and consistently. Compliance programs should be tailored to the needs and risks of each organization, and should be updated regularly to reflect the changes in the industry and to the law.

One way to improve compliance in healthcare is by deploying healthcare compliance software that can be customized for each organization’s compliance requirements. Solutions of this nature help organizations cope with multiple regulations, adapt to changing regulations, increase compliance efficiency, support growth and expansion, and improve patient outcomes. To find out if healthcare compliance software may be a solution for your organization, speak with a healthcare compliance expert.

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314,000 Patients Affected by Cyberattack on CompleteCare Health Network

Posted by Steve Alder

CompleteCare Health Network, a health system serving patients in southern New Jersey, has recently confirmed that the protected health information of 313,973 patients has potentially been compromised in an October 2023 ransomware attack.

An unauthorized third party gained access to certain CompleteCare Health Network computer systems and attempted to use ransomware to encrypt files. CompleteCare Health Network said this was a sophisticated ransomware attack that was detected and stopped on or around October 12, 2023. Third-party cybersecurity experts were engaged to investigate the attack and determine the nature of any unauthorized activity, and whether any patient data was involved. The substitute breach notice on the CompleteCare Health Network states, “Please know that we have taken steps to ensure your data will not be further published or distributed,” which appears to confirm that there was data exfiltration, the threat group behind the attack threatened to publish the data, and payment was made to prevent that outcome.

CompleteCare Health Network conducted a review of all files on the affected systems and confirmed they contained protected health information. The types of information involved varied from patient to patient and may have included names, phone numbers, addresses, and some sensitive personal information and/or personal health information. Notification letters started to be mailed to the affected individuals on December 15, 2023. Each individual notification letter states the exact types of data involved. CompleteCare Health Network said no reports have been received to indicate any actual or attempted misuse of patient data, but as a precaution, complimentary credit monitoring and identity theft protection services have been offered to the affected individuals.

“Data security is one of our highest priorities. Upon discovering the incident, we immediately took the affected systems offline and began the process of securing and confirming the fortification of our systems,” said a spokesperson for CompleteCare Health Network. Measures taken in response to the breach include revising policies and procedures and network security software, and reviewing how patient data are stored and managed. Since the attack, the network has been monitored 24/7 by third-party cybersecurity experts and CompleteCare Health Network has engaged leading cybersecurity firms to assist with monitoring its network for the long term.

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Plaza Radiology Data Breach Affects Up to 569,000 Patients

Posted by Steve Alder

Plaza Radiology, which does business as Chattanooga Imaging across several locations in Tennessee and North Georgia, has suffered a cyberattack and data breach that has affected up to 569,000 patients.

Plaza Radiology identified the cyberattack on October 21, 2023, but did not disclose any details about the nature of the attack, other than stating that the initial results of the forensic investigation confirmed there had been unauthorized access to a small number of files on its network that contained patient information.

The analysis of the results from the forensic investigation is ongoing and, at this stage, there have been no reports of any actual or attempted misuse of patient data. Plaza Radiology reported the data breach to the HHS’ Office for Civil Rights on December 20, 2023, and said it will be mailing individual notification letters to the affected patients when the specific individuals affected have been identified and the types of data involved have been determined.

Legal counsel for Plaza Radiology confirmed that several steps have been taken in response to the security breach to improve cybersecurity and prevent similar breaches in the future. Those measures include changing passwords on accounts, enabling multi-factor authentication, replacing the affected desktop computers and network servers, and providing enhanced security awareness training to the workforce.

Plaza Radiology has confirmed that complimentary credit monitoring and identity theft protection services will be offered to individuals whose sensitive information was accessed in the attack and encourages all patients to be vigilant against identity theft and fraudulent uses of their data.

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Florida Bill Seeks Safe Harbor for Organizations with Robust Cybersecurity Programs

Posted by Steve Alder

Healthcare organizations and businesses in Florida could soon be given protection against data breach lawsuits if they implement and maintain cybersecurity measures that meet government and industry standards. The Florida Cybersecurity Incident Liability Act (H.B 473) has been introduced in the Florida legislature and aims to introduce a “safe harbor” that limits liability for all businesses that implement reasonable and appropriate cybersecurity measures that meet industry standards and cybersecurity frameworks.

Businesses can make significant investments in cybersecurity to protect their networks and sensitive data from unauthorized access, but the sophisticated nature of cyber threats means that cyberattacks may still succeed. It is now common for multiple lawsuits to be filed over data breaches that allege a failure to implement appropriate cybersecurity measures, irrespective of the cybersecurity measures that have been implemented. The Florida Cybersecurity Incident Liability Act is intended to provide businesses with a legal defense against tort claims in data breach lawsuits and encourage the adoption of security frameworks.

The Florida Cybersecurity Incident Liability Act will place limitations on liability for cybersecurity incidents. Counties, municipalities, and businesses that acquire, maintain, store, or use personal information will not be liable in connection with a cybersecurity incident provided they have adopted a cybersecurity program that substantially aligns with any standards, guidelines, or regulations that implement any of the following:

  • The NIST Framework for Improving Critical Infrastructure Cybersecurity
  • NIST Special Publication 800-171 – Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations
  • NIST Special Publication 800-53 and 800-53A – Security and Privacy Controls for Information Systems and Organizations / Assessing Security and Privacy Controls in Information Systems and Organizations
  • The Federal Risk and Authorization Management Program 42 security assessment framework
  • The Center for Internet Security (CIS) Critical Security Controls.
  • The International Organization for Standardization/International Electrotechnical Commission 27000 series (ISO/IEC 27000) family of standards

There will also be limitations on liability for entities that are regulated by the state or Federal Government or that are otherwise subject to the following laws and regulations:

  • The Health Insurance Portability and Accountability Act’s security requirements (45 C.F.R. part 160 and part 164 55 subparts A and C)
  • The Health Information Technology for Economic and Clinical Health (HITECH) Act requirements (45 C.F.R. parts 160 and 164.)
  • Title V of the Gramm-Leach-Bliley Act
  • The Federal Information Security Modernization Act of 2014

The scale and scope of substantial alignment of a cybersecurity program with these laws reflect the size, complexity, and nature of the business activities, as well as the sensitivity of the personal information collected and stored, the availability and cost of security improvement tools, and the available resources for cybersecurity. In data breach lawsuits, the defendant will have the burden of proof to establish substantial compliance with these laws, cybersecurity frameworks, and standards.

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The Benefits of Outsourced Healthcare Compliance

Posted by Steve Alder

Outsourced healthcare compliance is when external experts or agencies take responsibility for some of an organization’s compliance obligations – either working inhouse as a separate compliance unit, working inhouse as a consultant to a compliance team, or working remotely via healthcare compliance software. They can also work as outsourced compliance experts for one particular regulation (i.e., HIPAA), or one element of multiple regulations (i.e., workforce training).

Outsourced healthcare compliance services can perform a wide range of compliance tasks, including risk assessments, policy development, training programs, audits, and ongoing compliance monitoring. By outsourcing these tasks, healthcare organizations can leverage specialized knowledge and experience not readily available in-house or lacking the resources to keep up to date with changes to federal, state, and industry regulations.

The Benefits of Outsourced Healthcare Compliance

Outsourced healthcare compliance has the primary benefit of enabling organizations to concentrate on core healthcare operations while entrusting some or all of their compliance obligations to experts. Some of the other benefits of outsourced healthcare compliance include:

Access to Specialized Knowledge

It is difficult for small compliance teams to keep up to date with every federal, state, and industry healthcare compliance requirement. Outsourced healthcare compliance provides access to experienced compliance professionals who are not only up to date with current compliance requirements, but who are also aware of changes under consideration.

Enhanced Efficiency

Due to having specialized knowledge of all applicable compliance regulations, outsourced healthcare compliance services can enhance efficiency by eliminating duplicated requirements – for example, HIPAA, OSHA, and CMS’ conditions for participation in Medicare all include similar emergency preparedness requirements.

Risk Reduction

Having specialized knowledge can also help organizations reduce the risk of non-compliance in cases where (for example) a provision of state law preempts a provision of HIPAA or additional training requirements exist due to the nature of an organization’s operations. Reducing the risks of non-compliance reduces the likelihood of penalties for non-compliance.

Better Trained Workforce

Due to their experience with different types of healthcare organizations, outsourced healthcare compliance services are often more familiar with how workforces absorb and apply training. This means training sessions can be better compiled and delivered by an external source to increase the likelihood of a better trained and compliant workforce.

Cost Savings

Outsourcing healthcare compliance can lead to cost savings by avoiding the requirement to hire an employee with the necessary compliance experience (i.e., a HIPAA Privacy Official). By comparison, outsourcing healthcare compliance allows organizations to pay for external compliance services on an as-needed basis.

How to Evaluate External Compliance Services

Selecting an external compliance service requires careful consideration of several key factors. It is important that, if a service provider is offering a technology solution, that the technology solution is customizable to meet all the organization’s compliance obligations. It is also important the provider offers technical and administrative support to deploy and configure the solution.

Other tips include ensuring the provider can demonstrate expertise in healthcare compliance, and an  understanding of industry regulations and best practices. It may also be necessary to research the provider’s reputation via a reputable source to assess their previous successes and failures – particularly with regards to integrating their technology solution into an existing IT infrastructure.

Finally, it is vital that prospective outsourced healthcare compliance experts provide reasonable expectations of what their services might entail. These expectations should include loss of organization control and the potential for a lengthy transition period – during which time there may be operational disruptions. In all cases, before engaging an outsourced healthcare compliance service, it is best to seek independent compliance advice.

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