Regulatory Content for Healthcare and Life Sciences

Common Regulatory Challenges by Sector:

Healthcare Providers & Hospital Systems

Healthcare providers and hospital systems face a number of regulatory compliance challenges, which can be complex and time-consuming to navigate. Some of the key challenges include:

• HIPAA compliance: Healthcare providers and hospital systems are required to comply with the Health Insurance Portability and Accountability Act (HIPAA), which sets strict rules around the privacy and security of patient health information.
• Medicare and Medicaid compliance: Healthcare providers and hospital systems that participate in Medicare and Medicaid programs must comply with a range of regulations, including rules around billing and coding, quality reporting, and patient safety.
• The HITECH Act: Health Information Technology for Economic and Clinical Health (HITECH) Act Act encourages the adoption of electronic health records (EHRs) and related technologies. Providers must ensure their EHR systems meet the standards for privacy, security, and meaningful use to receive financial incentives and avoid penalties.
• The 21st Century Cures Act: This legislation aims to promote medical innovation and improve patient access to new treatments. Providers need to comply with the provisions related to EHR interoperability, information sharing, and patient data access.
• The Joint Commission Accreditation: Healthcare providers and hospital systems must meet specific quality and safety standards set by The Joint Commission (TJC) to maintain accreditation. The Joint Commission regularly conducts surveys and audits to ensure compliance.
• Compliance with state and local regulations: Healthcare providers and hospital systems must comply with a range of state and local regulations, which can vary widely depending on the jurisdiction.
• Compliance with emerging regulations: Healthcare providers and hospital systems must stay up to date with emerging regulations, such as those related to telehealth and cybersecurity, and ensure that they are complying with these new requirements.

Navigating these regulatory compliance challenges can be difficult, but with the Regology Regulatory Intelligence Platform, healthcare providers and hospital systems can enhance their ability to navigate regulatory change and compliance. 

Pharmaceutical & Biotech Companies

Pharmaceutical and biotech companies face a range of regulatory compliance challenges, which can be complex and time-consuming to navigate. Some of the key challenges include:

• FDA regulations: Pharmaceutical and biotech companies are heavily regulated by the US Food and Drug Administration (FDA). Companies must comply with FDA regulations related to drug development, clinical trials, manufacturing, labeling, and advertising.
• International regulations: Pharmaceutical and biotech companies must also comply with regulations in the countries where they do business. These regulations can vary widely by country and can include requirements related to drug safety, efficacy, and marketing.
• Good Manufacturing Practices (GMP): Pharmaceutical and biotech companies must adhere to GMP regulations for the production of drugs and medical devices. GMP regulations ensure that products are consistently produced and controlled to meet quality standards.
• Data privacy regulations: Pharmaceutical and biotech companies collect and use sensitive personal data in the course of their business. As such, they must comply with data privacy regulations such as the General Data Protection Regulation (GDPR) in the European Union.
• Anti-corruption regulations: Pharmaceutical and biotech companies must comply with anti-corruption regulations such as the US Foreign Corrupt Practices Act (FCPA) and the UK Bribery Act. These regulations prohibit companies from engaging in bribery or other corrupt activities when doing business abroad.
• Environmental regulations: Pharmaceutical and biotech companies must comply with environmental regulations related to the disposal of hazardous waste and the impact of their operations on the environment.

Navigating these regulatory compliance challenges can be difficult, but with the Regology Regulatory Intelligence Platform, pharmaceutical, and biotech companies can enhance their ability to navigate regulatory change and compliance. 

Health Insurance Payors

Health insurance payors, such as insurance companies and managed care organizations, face a number of regulatory compliance challenges. Some of the key challenges include:

• HIPAA compliance: Health insurance payors are required to comply with the Health Insurance Portability and Accountability Act (HIPAA), which sets strict rules around the privacy and security of patient health information.
• Affordable Care Act (ACA) compliance: Health insurance payors must comply with the Affordable Care Act, which includes provisions related to insurance coverage, medical loss ratios, and quality reporting.
• State insurance regulations: Health insurance payors must comply with a range of state regulations related to insurance coverage, benefit design, and pricing.
• Anti-fraud regulations: Health insurance payors must comply with regulations related to fraud, waste, and abuse in the healthcare system. These regulations are enforced by agencies such as the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS).
• Medicare Advantage and Medicaid Managed Care regulations: Health insurance payors that participate in Medicare Advantage and Medicaid Managed Care programs must comply with a range of regulations related to benefits, quality reporting, and network adequacy.
• Consumer protection regulations: Health insurance payors must comply with regulations related to consumer protection, such as those related to appeals and grievances, network adequacy, and transparency in pricing and coverage.

Navigating these regulatory compliance challenges can be difficult, but with the Regology Regulatory Intelligence Platform, health insurance payors can enhance their ability to navigate regulatory change and compliance. 

Medical Device Manufacturers

Medical device manufacturers face a range of regulatory compliance challenges, which can be complex and time-consuming to navigate. Some of the key challenges include:

• FDA Regulations: Medical device manufacturers are heavily regulated by the US Food and Drug Administration (FDA). Companies must comply with FDA regulations related to device design, development, clinical trials, manufacturing, labeling, and advertising.
• International regulations: Medical device manufacturers must also comply with regulations in the countries where they do business. These regulations can vary widely by country and can include requirements related to devise safety, efficacy, and marketing.
• Good Manufacturing Practices (GMP): Medical device manufacturers must adhere to GMP regulations for the production of medical devices. GMP regulations ensure that products are consistently produced and controlled to meet quality standards.
• Data privacy regulations: Medical device manufacturers collect and use sensitive personal data in the course of their business. As such, they must comply with data privacy regulations such as the General Data Protection Regulation (GDPR) in the European Union.
• Anti-corruption regulations: Medical device manufacturers must comply with anti-corruption laws such as the US Foreign Corrupt Practices Act (FCPA) and the UK Bribery Act. These regulations prohibit companies from engaging in bribery or other corrupt activities when doing business abroad.
• Environmental regulations: Medical device manufacturers must comply with environmental regulations related to the disposal of hazardous waste and the impact of their operations on the environment.
• Unique Device Identification (UDI) requirements: Medical device manufacturers must comply with UDI requirements, which require them to assign a unique identifier to each medical device they produce. This is intended to help improve patient safety and traceability in the supply chain.

Navigating these regulatory compliance challenges can be difficult, but with the Regology Regulatory Intelligence Platform, medical device manufacturers can enhance their ability to navigate regulatory change and compliance. 

Healthcare Administration

Healthcare administration involves managing the business operations of healthcare organizations, such as hospitals, clinics, and medical practices. Healthcare administrators face a range of regulatory compliance challenges, including:

• HIPAA compliance: Healthcare administrators must ensure that their organizations comply with the Health Insurance Portability and Accountability Act (HIPAA), which sets strict rules around the privacy and security of patient health information.
• Medicare and Medicaid compliance: Healthcare administrators must ensure that their organizations comply with regulations related to billing and coding, quality reporting, and patient safety for Medicare and Medicaid programs.
• The Joint Commission Accreditation: Healthcare administrators must meet specific quality and safety standards set by The Joint Commission (TJC) to maintain accreditation. The Joint Commission regularly conducts surveys and audits to ensure compliance.
• OSHA regulations: Healthcare administrators must ensure that their organizations comply with regulations related to workplace safety, which are set by the Occupational Safety and Health Administration (OSHA).
• Anti-discrimination laws: Healthcare administrators must ensure that their organizations comply with laws related to anti-discrimination, including Title VII of the Civil Rights Act, the Americans with Disabilities Act (ADA), and the Age Discrimination in Employment Act (ADEA).
• Compliance with emerging regulations: Healthcare administrators must stay up to date with emerging regulations, such as those related to telehealth and cybersecurity, and ensure that their organizations are complying with these new requirements.

Navigating these regulatory compliance challenges can be difficult, but with the Regology Regulatory Intelligence Platform, healthcare administrators can enhance their ability to navigate regulatory change and compliance. 

Healthcare Technology 

• Healthcare technology providers face a range of regulatory compliance challenges, which can be complex and time-consuming to navigate. Some of the key challenges include:
• FDA Regulations: Healthcare technology providers are regulated by the US Food and Drug Administration (FDA) for medical software, mobile medical applications, and other healthcare-related technology. Companies must comply with FDA regulations related to device design, development, clinical trials, manufacturing, labeling, and advertising.
• Health Insurance Portability and Accountability Act (HIPAA) compliance: Healthcare technology providers must ensure that they comply with HIPAA’s requirements, which set strict rules around the privacy and security of patient health information.
• Cybersecurity regulations: Healthcare technology providers must comply with regulations related to cybersecurity, such as those established by the National Institute of Standards and Technology (NIST) and the Cybersecurity Information Sharing Act (CISA).
• Data privacy regulations: Healthcare technology providers collect and use sensitive personal data in the course of their business. As such, they must comply with data privacy regulations such as the General Data Protection Regulation (GDPR) in the European Union.
• Anti-corruption regulations: Healthcare technology providers must comply with anti-corruption laws such as the US Foreign Corrupt Practices Act (FCPA) and the UK Bribery Act. These regulations prohibit companies from engaging in bribery or other corrupt activities when doing business abroad.
• Reimbursement regulations: Healthcare technology providers must ensure that their products and services are in compliance with reimbursement regulations, including those established by Medicare and Medicaid.
• Telehealth regulations: Healthcare technology providers must comply with regulations related to telehealth, which can vary by state and by type of service.

Navigating these regulatory compliance challenges can be difficult, but with the Regology Regulatory Intelligence Platform, healthcare technology providers can enhance their ability to navigate regulatory change and compliance.

Caregiving Services

Caregiving service providers face a range of regulatory compliance challenges, which can be complex and time-consuming to navigate. Some of the key challenges include:

• State and local regulations: Caregiving services must comply with a range of state and local regulations related to licensing, insurance, and employee background checks.
• Employment regulations: Caregiving services must comply with federal and state employment regulations, including those related to minimum wage, overtime, and discrimination.
• Medicare and Medicaid compliance: Caregiving services that participate in Medicare and Medicaid programs must comply with regulations related to billing and coding, quality reporting, and patient safety.
• HIPAA compliance: Caregiving services must ensure that they comply with the Health Insurance Portability and Accountability Act (HIPAA), which sets strict rules around the privacy and security of patient health information.
• RISE Act and American Rescue Plan Act: The RISE Act (Recognize, Assist, Include, Support, and Engage Family Caregivers Act) was signed into law in 2018, requiring the development of a national strategy to support family caregivers. Caregiving services may need to adapt their policies and procedures to comply with this new legislation. The American Rescue Plan Act includes provisions that provide financial support to caregiving services to help them manage the impacts of the COVID-19 pandemic. This act also includes funding for states to provide additional support to family caregivers.
• Consumer protection regulations: Caregiving services must comply with regulations related to consumer protection, such as those related to contract disclosure, transparency in pricing and services, and billing practices.
• Workers’ compensation regulations: Caregiving services must comply with workers’ compensation regulations, which vary by state and provide coverage for employees who are injured or become ill on the job.

Navigating these regulatory compliance challenges can be difficult, but with the Regology Regulatory Intelligence Platform, caregiving service providers can enhance their ability to navigate regulatory change and compliance.