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The complete healthcare compliance guide for digital health solutions

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Mar 06, 2023

5 min read

The healthcare industry is highly regulated and patient privacy and care are paramount. Digital health solutions in particular are experiencing heightened scrutiny from patients and regulatory bodies. As a result, healthcare compliance should be a top concern for every healthcare provider and organization.

In order to properly maintain full regulatory compliance in healthcare, digital solutions must first understand what compliance really means and what the common issues are. We have put together a guide for understanding what you need to know, along with a compliance audit checklist to see how your solution stacks up.

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What is healthcare compliance?

Healthcare compliance is defined as the ongoing process of meeting the legal, ethical, and professional standards specific to a healthcare organization or provider.

There are numerous federal, state, local and private agencies responsible for issuing healthcare compliance laws and regulations. Developing, implementing, and updating compliance programs that align with the rules of each agency can be a challenging and time-consuming—but necessary—endeavor.

Beyond an altruistic desire to eliminate fraud, waste, and abuse, digital health solutions don’t have a choice when it comes to health compliance—the Patient Protection and Affordable Care Act (ACA) mandates that providers implement a compliance plan.

Compliance issues in healthcare

With increasingly stringent data protection laws, healthcare organizations must prioritize their compliance efforts to safeguard their patients’ data and avoid costly legal and regulatory consequences.

One of the major challenges organizations face is the vast scope of compliance standards in healthcare. Compliance regulations encompass everything from patient care, billing, reimbursement, managed care contracting, research standards, ADA compliance, OSHA, the Joint Commission standards and HIPAA privacy and security considerations. Failure to comply with any one of them can have severe consequences.

Digital health solutions are particularly vulnerable to compliance violations, liability, and adverse repercussions. Complying with health information technology laws and regulations can help protect against any potential data breaches or cybersecurity threats.

Furthermore, the regulatory landscape is constantly evolving, with new laws and regulations emerging regularly. Healthcare organizations must stay vigilant and continually reassess the effectiveness of their healthcare compliance programs so they can ensure they are up-to-date and meeting all legal requirements.

Compliance audit checklist

Every healthcare provider and organization should have a compliance program in place that features education, communication and proactive measures.

While the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has produced guidance documents that help organizations establish a culture committed to compliance, it can be difficult to understand where to start. Below is a checklist to help ensure you have the foundation for a strong healthcare regulations and compliance program:

  1. Conduct a risk assessment
    Identify potential areas of privacy and security risks within your digital health solution by reviewing things like HIPAA guidelines for healthcare professionals, FDA regulations, and state-specific laws. Make sure to examine the overall design and functionality of your solution against those regulations and standards, including compliance in software development and medical coding compliance.
  2. Review policies and procedures
    Develop, distribute, and implement written standards of conduct that describe your organization’s commitment to meeting legal and ethical standards. Ensure your policies address key compliance areas, such as data privacy and security, informed consent, and reporting requirements. These standards should be communicated to all employees, contractors, and vendors working with your organization.
  3. Assess training and education programs
    Make sure employees have access to regular education and training programs that cover up-to-date compliance policies and procedures, applicable laws, and regulations. Regularly evaluate the effectiveness of your training programs to ensure that they are providing the necessary knowledge and skills to meet medical compliance requirements.
  4. Review data security protocols
    Evaluate your data security protocols, including data encryption, access controls, and secure data storage, to ensure they meet industry best practices for healthcare IT compliance.
  5. Review incident response procedures
    Develop and maintain open lines of communication so that employees can report compliance concerns without fear of retaliation – including a process for anonymous reporting. Institute a process for promptly responding to complaints, with the built-in ability to impose corrective action and discipline for noncompliance of your employees.
  6. Evaluate ongoing compliance monitoring
    Implement and regularly review internal monitoring and audit processes to measure compliance so you can address known deficiencies in a timely manner.
  7. Document the audit
    Record any findings from your audit, including any areas of noncompliance or potential risk, to guide the development of an action plan to address these issues.

Healthcare compliance requires ongoing attention and monitoring to ensure that your organization is operating within the scope of all applicable regulations and standards. By following this compliance audit checklist, you can ensure your organization has an effective program in place that meets legal and ethical obligations.

Getting certified in healthcare compliance

Healthcare compliance programs should promote not only compliance with rules, requirements and standards of ethical conduct, but also a culture that promotes prevention, detection, and resolution of conduct that does not conform to these requirements. Healthcare compliance audits are an effective means of measuring the effectiveness of your compliance.

Compared to traditional care delivery models, there are added layers of complexity for digital health solutions. Organizations need to consider interoperability and FHIR compliance on top of standard healthcare compliance. HTD is your partner for planning, designing and developing custom healthcare software that empowers people and takes all aspects of compliance into account.

HTD is a digital services group working with the healthcare and wellness industries. HTD's experienced team works with clients to plan, design, and build custom healthcare software.

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