SOC 2 and HIPAA Compliance for Remote Patient Monitoring (RPM)

Are you aware of compliance requirements for remote monitoring services? When it comes to modern day healthcare, Remote Patient Monitoring (RPM) plays a critical role in providing effective care, outside of their in person clinic visits, i.e. allowing patients to be continuously managed and monitored from the comfort of their homes. RPM uses latest technology to track patients’ health data with a goal to improve patient outcomes and lower healthcare costs for both patients and providers.

Since healthcare industry is highly regulated when it comes to patient and data security, all remote patient monitoring companies, software, healthcare providers, and care software development companies need to meet very specific compliance requirements. The two most common healthcare regulatory compliances in United States are SOC 2 and HIPAA. If you need more information on these compliance requirements, read on.

What is SOC 2 Compliance?

System and Organization Controls 2, also known as SOC 2 is concerned with sensitive data management. Just as its name suggests, this compliance framework is related to system and organization controls that deal with data transfer and management.

This compliance is specially formulated for service providers, companies, and businesses involved in technology and cloud-based services and handle client data. Since remote patient monitoring companies deal with patient data tracking and management, meeting SOC 2 compliance is a necessity for all RPM service providers. The American Institute of Certified Public Accountants (AICPA) developed SOC 2 compliance which works on the below mentioned five principles:

• Security: It is focused on securing systems and data from illegal access.
• Availability: It ensures the systems are available, accessible, and operational.
• Processing Integrity: It refers to ensuring correct and error-free processing of data.
• Confidentiality: It ensures protection of confidential data from unauthorized access.
• Privacy: It includes managing information in compliance with privacy policies and legal terms.

SOC 2 Compliance for Remote Patient Monitoring (RPM) Software

SOC 2 is one of the important compliance for healthcare organizations dealing in remote patient monitoring services. To meet SOC 2 compliance standards, providers need to make sure their security system and data handling services are being processed based on the Trust Service Criteria standards. To achieve this, software developers or companies go through a rigorous audit procedure, including:

1. Conducting Risk Assessments: As the name suggests, conducting risk assessments is the foremost step to meet the compliance requirements. Do a thorough risk assessment to identify any vulnerabilities, risks, and threats to your RPM system. To achieve this, follow the below steps:

• Asset Identification: Keep a track of your RPM elements, such as system-related hardware, software, and data storage devices.
• Threat Assessment: Next, conducting a threat assessment that helps identify potential threats, cyber attacks, and software defects.
• Impact Identification: The third one is assessing the potential impact of threats and software vulnerabilities on data security and system integrity.

2. Conducting Regular Audits: Just like assessments, audits are necessary to identify any software breaches. When it comes to meeting and maintaining SOC 2 compliance, regular audits are a key to avoid security threats to a healthcare organization. The most common audits include:

• Internal Audits: Internal audits are done by an in-office team either on the development company or healthcare provider’s end. By conducting periodic internal audits, healthcare providers can make sure they stay compliant to the SOC 2 rules and help identify areas for improvement, if any.
• External audits: As the name suggests, external audits are done by an external or an out-of-office team. You can most possibly ask a third-party auditing company to conduct an annual SOC 2 audit on the behalf of your organization. Since third parties have no vested interests, they’ll assess your controls and deliver an accurate SOC 2 report.

3. Implementing Security Controls: Security controls, such as access control is used to monitor the security of an RPM system. To find out which security controls you need, use the risk assessment criteria. Some of the common security controls include:

• Access Control: Access control is used to avoid unauthorized or unwanted access on your system. It ensures that only authorized healthcare providers have access to the RPM system. To implement access control, multi-factor authentication plays a significant role.
• Data Encryption: For cloud-based software, data encryption is a necessity. To avoid misuse of your patients’ data when it’s still on the cloud or on the transmission medium, encrypt the data using the encryption technology. Not only this, it is important to encrypt the data stored in databases and networks, no matter if it’s at rest or in transit.
• Monitoring and Tracking: To avoid any security breaches, it is important to implement continuous data monitoring and tracking approach. Right from the source of data generation to the end of system operations, identify and respond to security breaches with monitoring and data tracking.

4. Documenting and Training: To make sure security and data management protocols are met at every step, regular training and detailed documentation on SOC 2 compliance plays a critical role. To ensure your team is competent and adequately educated to meet compliance requirements, consider providing:

• Documentation: Keep thorough records of security policies, procedures, and controls to devise incident response plans and complete risk assessments on your own.
• Training: Provide regular training to your staff and patients about the security concerns, rules, and best practices to help them identify the threats and understand their responsibilities in ensuring SOC 2 compliance.

What is HIPAA Compliance?

Health Insurance Portability and Accountability Act, also known as HIPAA is a federal compliance law designed to protect patient health information. Formulated especially for healthcare industry, this compliance ensures protection of patient data and electronic PHI.

The Department of Health and Human Services (HHS) is responsible for the enforcement of the HIPAA compliance and mandates the safeguarding of Protected Health Information (PHI).

Since modern day healthcare industry is focused on RPM technology to deliver convenient in-home care to patients, meeting the HIPAA compliance that safeguards patient data and ensure confidentiality of health information over the cloud software is a necessity.

The key rules involved in maintaining HIPAA compliance includes:

• Privacy Rule: As the name denotes, this rule governs the use and disclosure of Protected Health Information.
• Security Rule: For ensuring security of the electronic PHI, security rule is enforced. It safeguards PHI and promotes confidentiality, integrity, and availability.
• Breach Notification Rule: This notification rule is to inform and notify both patients and HHS about potential data breaches or security risks.
• Omnibus Rule: The Omnibus Rule updates HIPAA laws to stay in sync with the technological advancements and safeguard PHI.

HIPAA Compliance for Remote Patient Monitoring (RPM) Software

When it comes to meeting HIPAA compliance, providers needs to adhere to the above mentioned Privacy Rule, Security Rule, Breach Notification Rule, and Omnibus Rule. To maintain compliance, software developers or healthcare providers must concentrate on the Security Rule.

1. Conducting Risk Analysis: To avoid any potential data breaches or security threats, a detailed risk assessment is necessary. To conduct risk analysis to ensure HIPAA compliance for your healthcare practice, follow the below:

• Assess Potential Risks: Check the possibility of potential threats or security risks to ePHI, such as illegal or unauthorized access, data breaches, and system failure.

2. Implementing Safeguards: The second step in ensuring HIPAA compliance is implementing safeguards to protect patient data. HIPAA requires three types of safeguards, namely administrative, physical, and technical safeguards to protect ePHI. Using risk analysis, you can implement the following safeguards:

• Administrative Safeguards: This involves the policies and procedures that govern the selection, development, and maintenance of security measures. 

• Physical Safeguards: This involves the measures to protect and safeguard physical access to ePHI.
• Technical Safeguards: This involves technology-based safeguarding measures for ePHI.

3. Breach Notification Procedures: Whenever a data breach happens, it’s important to generate an alert to the affected individuals, healthcare practices, remote care patient companies, and everyone involved. In the case of an ePHI-related data breach, HIPAA requires:

• Alert Generation: It is necessary to notify affected individuals or those whose ePHI has been compromised.
• Report to HHS: If the data breach affects 500 or more individuals, notify the HHS.
• Contact Media: In case, the data breach can potentially affects more than 500 people in a given jurisdiction, contact media outlets.

4. Documentation & Compliance Monitoring: To guarantee your service provider meets the HIPAA compliance requirements, maintain a detailed documentation that lists all/ any measures taken to safeguard data security and undertake regular compliance monitoring to guarantee HIPAA compliance.

• Documentation: Have a detailed document that keeps track of risk assessments, safeguards, training, and breach alerts.
• Monitoring: Monitor compliance by reviewing and updating HIPAA policies, conducting internal audits, and addressing compliance gaps, if any.

Maintain SOC 2 & HIPAA Compliance With HealthArc’s Advanced Care Management Software

When it comes to ensuring data protection for remote patient monitoring software and healthcare providers offering RPM services, meeting the SOC 2 and HIPAA compliance is a necessity. By implementing the required security controls, preventing data breaches, conducting regular risk assessments, and providing regular training, healthcare providers can safeguard patient data and protect their privacy in the long run, thereby making an RPM system more reliable and secure.

HealthArc’s all-in-one HIPAA & SOC 2 compliant advanced care management platform helps practices in connecting to their patients in a remote setting, without compromising the security and protection of confidential patient data. With our remote care software, we optimize reimbursement and minimize documentation for increased clinical efficiency.

Being HIPAA and Soc 2 compliant, we promise unmatched data security and privacy, along with adherence to CMS guidelines and policies. Monitor your patients 24/7, refill prescriptions, review diagnostics, and make referrals using HealthArc.

To find out how our digital health platform can help you reduce hospital readmissions and achieve your healthcare practice goals, schedule a free demo or give us a call at +201 885 5571.

Bibliography

SOC 2 Compliance: American Institute of CPAs (AICPA). (2020). SOC 2: The Basics. https://www.aicpa-cima.com/topic/audit-assurance/audit-and-assurance-greater-than-soc-2

HIPAA Compliance: U.S. Department of Health and Human Services (HHS). (2013). Health Information Privacy. https://www.hhs.gov/hipaa/for-professionals/privacy/index.html

Remote Patient Monitoring (RPM) and Compliance: American Telemedicine Association (ATA). (2022). Telemedicine and Remote Patient Monitoring: A Guide to Compliance. https://telehealth.hhs.gov/providers/preparing-patients-for-telehealth/telehealth-and-remote-patient-monitoring