Navigating Compliance in the Healthcare Sector

Ethical Considerations

The healthcare industry is based on a set of ethical principles that guide patient interactions as well as relationships with healthcare providers, vendors and partners. On a patient level, the primary ethical considerations include such universal healthcare principles as informed consent, patient autonomy, avoiding harm and ensuring equity and access, among others.

On a healthcare provider and partner level, which directly relates to corporate compliance, healthcare ethical guidelines require transparency and honesty in communication, avoiding conflicts of interest, ethical resource allocation, developing whistleblower channels, and long-term sustainability. Businesses operating in the healthcare sector are expected to adhere to these principles, reflecting them in their governance and compliance policies, their organizational structure and while working with their vendors and suppliers.

Data Privacy Requirements

In healthcare, data privacy is a paramount requirement, which sets high standards for all touchpoints, from patient intake, screening and questionnaires to sharing information with vendors and partners, making filings with regulators and setting up digital channels. 

Such regulations as HIPAA, CCPA  in the U.S., PIPEDA and HIA in Canada and GDRP in the E.U. require businesses operating in the healthcare industry to conduct regular risk assessments, set up safeguards and arrange training to ensure safe handling of protected information. The teams shall observe the applicable requirements at all stages by having safe data handling practices and setting up a secure digital environment that adheres to the regulations.

Heavy Regulations with Industry-Specific Laws

The healthcare sector is among the most regulated industries subject to international, federal, state and local regulations. Specifically, in the U.S. and Canada, healthcare businesses are scrutinized for compliance and are always penalized for violations.

Medical substances and devices must conform to the requirements of regulatory bodies such as the U.S. Foods and Drugs Administration or Health Canada, which assess the safety and efficiency of medical products according to health standards. Additionally, healthcare providers in the U.S. working with patients who receive "designated health services" paid by Medicare or Medicaid should comply with the Stark Law, which regulates such aspects of compliance as:

• making referrals to other organizations,
• financial relationships, 
• structuring of agreements,
• maintaining comprehensive records and documentation,
• implementing compliance programs,
• risk mitigation and audits.

Automating Compliance 

By automating compliance, healthcare providers can improve their efficiency and scalability through adherence to the regulations at all times. In doing so, companies need to ensure compliance both on the patient's level and on the internal company level, reflected in its entity management and organizational structure.

According to numerous case studies and reports, entity management software plays a pivotal role in automating compliance on the company level by offering automated workflows and reminders and helping teams stay proactive. Entity management software allows automated tracking, helps to avoid missed tasks and deadlines and provides audit trails, offering accountability within an organization.

Creating a Single Source of Truth for All Corporate Records 

In the data-driven environment, having a single source of truth for the healthcare business is critical to ensure regulatory compliance. The teams need a central database for all corporate records to access, process and share information instantly.

By utilizing centralized platforms such as entity management software, healthcare compliance teams allow real-time access to all corporate information from anywhere on any device. When healthcare businesses leverage a centralized database for their records, companies can provide access rights to their data to third parties, utilize automation tools and ensure data accuracy and consistency.

Provide for Data-Safety and Security

As data safety and security are among the primary concerns for the healthcare industry, companies need secure solutions to ensure compliance. These solutions should adhere to applicable regulations, like CCPA and GDRP, and provide for a high level of protection against data loss and cybercrime.

When companies operate in such data-intensive businesses as healthcare, they need robust technologies to protect both their corporate data and the personal data of patients. Instead of storing information locally, exchanging files by email or creating third-party risks by sharing access, businesses need safe technologies like entity management software to have their critical data secure. 

Streamlining Communication Among All Stakeholders 

As many healthcare organizations have highly diversified structures operating across sectors, geographies and jurisdictions, businesses seeking to enable regulatory governance and compliance need a central platform to ensure efficient communication for all teams. Meanwhile, the global shift to remote working places additional emphasis on digital technologies, capable to streamline collaboration and increase engagement.

Healthcare businesses that leverage entity management software provide all their teams, stakeholders and third parties with various access rights, which allow them to update and add data in real-time and to collaborate on the platform. In turn, improved collaboration and interdepartmental visibility results in higher efficiency and better compliance,