HEALTHCARE

Improve Compliance for Healthcare with Generative AI

Whether you’re a hospital, health system, health insurance plan, life sciences, or medical device company, Regology’s Generative AI can help you keep abreast of the latest regulatory developments.

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AI Helps Get Ahead of Changes

With the continued digitization of healthcare, there is a growing number of policy changes and regulations introduced to address recent developments, such as telehealth and alternative healthcare models. These rapid changes require a more integrated and agile regulatory change management approach. Is your organization ready?

Optimize Legal Coverage

Ensure your corporate blueprint covers the latest policy changes to Medicare and Medicaid programs (such as Price Transparency Requirements) and other supplemental areas that present a potential risk under key US Federal fraud and abuse statutes.

Innovate While Maintaining Compliance

Align your pharmaceutical development, manufacturing, and quality assurance with the latest regulatory guidance for sales and marketing practices, government drug price reporting, post-marketing drug safety reporting, and quality control activities.

Get the Diversity You Need

Cover diverse state and federal regulatory frameworks for health insurance in the US, including requirements for contract provisions, premium payment terms, and Centers for Medicare & Medicaid Services regulations and policies.

Comply with Compulsory FDA Requirements

Regulatory control increases with the classification of your medical device (Class I to Class III) whether you are a domestic or a foreign manufacturer intending to register with the FDA. Ensure you cover all the compulsory regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with, including PMA, IDE, QS and MDR.

Know the Latest Standards

With increased governmental oversight, healthcare administrators in private and public organizations face stringent demands and program requirements. Ensure your healthcare administration is aligned with the most up-to-date performance standards, reporting requirements, and other critical processes and procedures imposed by state and federal law.

Stay Abreast of Ongoing Regulatory Changes

With the recent regulatory advancements on the subject of interoperability, usability, accessibility, privacy and security of health IT, there have been many clarifications of HIPAA privacy rules and other related exchanges and uses of electronic health information. As a healthcare technology provider, you need to ensure a good grasp of the ongoing regulatory changes.

Include All Upcoming Legislation

Following the RAISE Act and the American Rescue Plan Act, more proposed legislation is underway to address caregiver and long-term care support. Look to include upcoming legislation in your regulatory coverage.

Largest Law Repository for Healthcare

Powered by the latest AI, our Smart Law Library comprises the largest database of laws and regulations, automatically updated with new requirements and changes across all U.S. jurisdictions.

Explore Regulatory Change Management

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AI-Powered Healthcare Regulatory Intelligence Platform

We infuse the latest AI into our regulatory intelligence platform to automate manual processes involved in managing regulatory change and compliance policies. Using our platform, you can be more proactive with your compliance programs and ensure timely policy adjustments across your organization.

Improve Regulatory Foresight

Anticipate change instead of reacting to new laws and regulations that have a direct impact on your healthcare, life sciences, or insurance organization.

Cut Down Alert Noise

Mitigate irrelevant notifications by only receiving those regulatory alerts that target your compliance requirements.

Reduce Costs

Bring higher levels of automation to your team to streamline workflows and drastically reduce your research and compliance costs.

Cover All Markets & Services

Even if your organization covers multiple healthcare products, services, and sectors, Regology enables you to tailor the platform to your unique regulatory needs.

Regology for Your Healthcare Organization

Our experts in the regulatory environment and SaaS are here to discuss your regulatory change and compliance concerns. Reach out anytime.

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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.

Tackling regulatory compliance hurdles can be a daunting task. However, with the Regology Regulatory Intelligence Platform, healthcare providers and hospital systems can handle regulatory transitions faster and maintain 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 Regology’s AI-powered platform that automates complex processes, pharmaceutical and biotech companies enhance their ability to manage 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.

Dealing with these regulatory compliance challenges can be difficult, but with our 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 device 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 regulatory compliance hurdles can be daunting. However, with Regology’s Regulatory Intelligence Platform, medical device manufacturers can bolster their capacity to steer through regulatory modifications and ensure 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.

Maintaining regulatory compliance in top shape can be tough. Yet, with the Regology Regulatory Intelligence Platform, healthcare administrators can simplify regulatory change management and ensure 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.

Addressing the intricacies of regulatory compliance can be challenging. Yet, with the support of the Regology Regulatory Intelligence Platform, healthcare technology providers can strengthen their regulatory change management and ensure 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.

Managing the complexities of regulatory compliance can be demanding. However, with the Regology Regulatory Intelligence Platform, caregiving service providers can uphold compliance by better managing regulatory changes.