Healthcare & Life Sciences

Improve Regulatory Compliance with AI

With the continued digitization of healthcare, a growing number of policies and regulations are introduced to address the latest developments, such as telehealth and alternative healthcare models. Whether you’re a hospital, health system, health insurance plan, life
sciences organization, or medical device company, Regology’s AI-driven platform can help you keep abreast of the latest regulatory updates.

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One Platform to Track and Manage Regulations

Keep Up with Frequent Changes

Get the latest updates on laws, regulations, and agency communications—whether local or international—that apply to your organization. Our AI-driven platform automates the tracking
and integration of updates in one customized law library.

Address Industry Requirements

We tailor your law library to the specific regulatory requirements of the healthcare and life sciences sector. Our platform is continuously updated to include new laws and amendments, covering Federal, State, and international regulations.

Conduct Risk Assessments

Prioritize regulatory changes according to their impact on your operations. Rank alert risk from high to low and assign it to appropriate team members to address accordingly.

Lower Costs and Resources

Whether it’s citation tracking or version control, Regology automates the most labor-intensive tasks, turning hours of work
into minutes. Mitigate risks and errors and free up resources, allowing your team to focus on high-value priorities.

How Regology Simplifies Compliance

AI-powered Regulatory Intelligence for Healthcare

Powered by the most advanced AI, our platform hosts the largest database of laws and regulations, automatically updated with new changes and requirements across all U.S. jurisdictions. Additionally, our generative AI assistant, Reggi, enables users to summarize and ask questions about laws and regulations directly in the law library.

Examples of Regulatory Topic Areas

Regology offers extensive topic coverage for the healthcare sector, including topics such as:

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HIPAA Compliance

Follow the strict rules around the privacy and security of patient health information set by the Health Insurance Portability and Accountability Act (HIPAA).

Medicare and Medicaid Compliance

Comply with a range of regulations, including rules
around billing and coding, quality reporting, and patient safety.

The HITECH Act

Meet the standards for privacy, security, and meaningful use to receive financial incentives and avoid penalties.

The 21st Century Cures Act

Comply with the provisions related to EHR interoperability,
information sharing, and patient data access.

The Joint Commission Accreditation

Incorporate specific quality and safety standards set
by The Joint Commission (TJC) to maintain accreditation.

Experience Results Company-wide

Integrate seamlessly with your existing GRC systems, allowing for streamlined information management and reporting, which are crucial for maintaining transparency and managing compliance risks.

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Enhance Organizational Agility

With Regology’s AI-driven platform, you adapt faster to regulatory changes, streamline compliance tasks, and redirect resources toward growth and innovation, reducing costs and improving operational efficiencies.

Stay Ahead in a Regulated World

Ready to transform your regulatory compliance strategy? Contact us to discover how our platform can work for you.

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Frequently Asked Questions

What is Regology?

Regology is a regulatory intelligence platform designed to simplify regulatory compliance for businesses of all sizes. Our platform provides comprehensive tools and resources to help you understand and navigate complex regulations relevant to your industry, enhancing compliance management.

How does Regology work?

Regology utilizes advanced AI Agents, algorithms, and machine learning to analyze regulatory information from global sources. It enables users to quickly identify all applicable legal content, query laws and regulations, monitor incoming changes with customized alerts, and easily map them to risks and controls, efficiently addressing compliance requirements.

What industries does Regology support?

Regology caters to a wide range of industries, with vast experience in banking and financial services, digital assets and crypto, online and land-based gaming, and technology, as well as healthcare, manufacturing and energy. Our platform is industry-agnostic and can accommodate the unique regulatory needs of different sectors, ensuring that businesses across various industries can benefit from our services.

Is Regology suitable for small businesses?

Yes, absolutely! Regology is designed to be accessible and user-friendly for businesses of all sizes. Whether you're a small startup or a large corporation, our platform offers scalable solutions to meet your compliance needs without overwhelming your resources.

How can I get started with Regology?

Getting started with Regology is easy! Simply fill out a short form to contact our team or request a platform demo, and we’ll be always available to assist you every step of the way.

Resources

Get Your Industry Insights Here

Compliance

August 11, 2025

Making Sense of the Noise: Staying Ahead of Compliance Changes

Compliance

August 5, 2025

From Spreadsheet to Strategy: Regulatory Compliance with Limited Resources

Banking

June 4, 2025

How Banks Will Be Handling Compliance in 2025

Ready to Learn More?

We would be happy to discuss your regulatory compliance needs. Contact our leading team of experts today.

Healthcare & Life Sciences

Healthcare & Life Sciences Compliance

With the continued digitization of healthcare, a growing number of policies and regulations are being introduced to address new developments like telehealth and alternative care models. These emerging regulatory expectations demand a more integrated and agile approach to change management. Whether you’re a hospital, health system, health insurance plan, life sciences company, or medical device manufacturer, Regology’s purpose-built AI agents can help you manage regulatory compliance with more foresight and confidence.

Request a demo

Largest Unified Law Repository

A complete, up-to-date, and trustworthy source of regulatory information is essential for identifying obligations early, interpreting them correctly, and implementing timely changes. Regology delivers the largest unified database of laws and regulations for the industry—continuously updated across all US federal and state jurisdictions, as well as globally—so your compliance team can act decisively, with the assurance that no critical requirement has been overlooked.

One Platform to Tackle Healthcare Compliance Needs

Healthcare and life sciences are some of the most highly regulated industries. What you want is early visibility into government oversight priorities, audit triggers, and policy changes, and this is where Regology can act as a force multiplier. Our regulatory intelligence platform uses purpose-built AI agents to continuously monitor and analyze laws, regulations, and new legislation, automatically identifying gaps and mapping applicable requirements to your policies and controls. It allows your team to act faster, stay proactive, and keep compliance programs up to date without wasting resources on low-value tasks.

Cover All Markets & Services

Even if your organization spans multiple healthcare products, services, and jurisdictions, Regology enables you to tailor the platform to your unique regulatory needs. Ensure no regulation slips through the cracks across any state, country, or sector you operate in.

Gain Regulatory Foresight

Skip the broad healthcare headlines and focus on operational triggers instead. Our AI agents actively monitor legislative progression and flag applicable changes so you can identify future high-risk areas and know where to focus your compliance resources.

Be Audit Ready

Embed audit readiness into your daily compliance workflow. Regology automatically captures every regulatory update, notifying the right team members, and maintains a complete, time-stamped history of actions taken. When audit time comes, your team can produce comprehensive, source-linked evidence without any last-minute scrambles, reducing audit stress.

Lower Costs & Fees

Bring higher levels of automation to drastically reduce legal research time and third-party outsourcing costs. Heavy-duty tasks like tracking citations, monitoring amendments, and performing impact analysis are handled by AI agents—turning hours of manual work into minutes. This not only saves time but also minimizes costly risks and hefty fines.

Regology for Your Healthcare Organization

From hospitals and health systems to pharmaceutical and biotech companies, medical device manufacturers, insurers, and caregiving services, our platform is built to interpret, map, and manage regulatory change with the precision, speed, and confidence your organization needs to stay ahead.

Care Providers

The Regology Platform helps hospitals (University Hospitals, Speciality Hospitals, Private Hospitals, Public Hospitals) and health systems take the stress out of compliance with the help of AI Agents. Instead of staff chasing down every new policy or update, our AI Agents do the heavy lifting—scanning changes, flagging what matters, and connecting the dots to your existing policies. The result? Less paperwork, fewer surprises, and more time for providers to focus on patient care.

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Medicare and Medicaid regulations

Hospitals and health systems participating in Medicare or Medicaid must comply with a range of rules around billing, coding, quality reporting, and patient safety to meet federal and state requirements.

State regulations

Providers must also navigate a myriad of state health regulations, which can vary widely by jurisdiction – from facility licensing requirements to public health mandates.

Emerging requirements

New regulations in areas like telehealth, cybersecurity, and pandemic response continue to arise. Providers need to stay up to date on these emerging rules and integrate them into their compliance programs.

HIPAA compliance

Providers must adhere to the Health Insurance Portability and Accountability Act (HIPAA), which sets strict rules for protecting the privacy and security of patient health information.

The HITECH Act

The Health Information Technology for Economic and Clinical Health (HITECH) Act encourages the adoption of electronic health records. Providers need to ensure their EHR systems meet standards for privacy, security, and meaningful use in order to receive financial incentives and avoid penalties.

The 21st Century Cures Act

This legislation promotes medical innovation and improved patient access to treatments. Healthcare organizations must comply with provisions related to electronic health record (EHR) interoperability, information sharing, and patient data access.

The Joint Commission accreditation

Hospitals and clinics must meet specific quality and safety standards set by The Joint Commission (TJC) to maintain accreditation. TJC regularly conducts surveys and audits to ensure healthcare providers uphold these standards.

Pharmaceutical & Biotech Companies

For pharma and biotech companies, compliance can feel like an obstacle to innovation. Regology’s AI Agents make it easier by tracking global requirements, interpreting changes, and linking them to your processes in real time. Teams no longer have to waste weeks on manual research or second-guess if they missed something—AI Agents give them the clarity and confidence to move breakthroughs forward faster.

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FDA regulations

Drug and biotech products are heavily regulated by the U.S. Food & Drug Administration. Companies must comply with FDA requirements at every stage—from research and clinical trials to manufacturing, labeling, marketing, and post-market surveillance.

International standards

Life sciences companies must also meet regulations in each country where they operate. These can include EU directives, ICH guidelines, and other national regulations governing drug safety, efficacy, and marketing authorization. Ensuring compliance across multiple regulatory regimes is a constant challenge.

Good Manufacturing Practices (GMP)

Companies must adhere to strict GMP standards for producing drugs and biologics. GMP guidelines ensure products are consistently produced and controlled according to quality standards, requiring comprehensive documentation and quality control processes.

Data privacy laws

Pharmaceutical and biotech organizations often handle sensitive personal data (e.g., patient information in clinical trials). They must comply with data protection regulations, such as the EU’s General Data Protection Regulation (GDPR) and other privacy laws, to ensure proper consent, data security, and confidentiality.

Anti-corruption laws

Firms must comply with laws such as the U.S. Foreign Corrupt Practices Act (FCPA) and the UK Bribery Act, which prohibit bribery and other corrupt practices. This is especially relevant when conducting international business, such as interacting with healthcare professionals or government officials abroad.

Environmental regulations

Life sciences companies must follow environmental laws related to the use and disposal of hazardous materials and waste from research and production. Compliance includes proper waste management, pollution controls, and meeting any environmental impact standards.

Payors

Health plans deal with a flood of shifting requirements across states and programs. Regology’s AI Agents help by watching for changes 24/7, pointing out what’s important, and tying it directly to your policies and controls. That means less manual work, smoother audits, and stronger compliance programs—without burning out your teams or blowing up your budget.

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HIPAA compliance

Like providers, payors must also comply with HIPAA’s strict privacy and security rules for member health information, ensuring all patient data is handled and shared in a lawful manner.

Affordable Care Act (ACA)

Insurers must meet numerous ACA requirements, from covering essential health benefits and preventing exclusions for pre-existing conditions to maintaining certain medical loss ratios and reporting on quality of care.

State insurance regulations

Every state has its own insurance laws governing policy coverage mandates, premium pricing, network adequacy, and consumer protections. Payors must stay compliant with each state’s insurance commissioner and regulatory guidelines where they operate.

Anti-fraud and abuse rules

Payors are subject to regulations aiming to reduce fraud, waste, and abuse in healthcare. Agencies like the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) enforce strict rules around claims processing, billing integrity, and program fraud control.

Medicare Advantage and Medicaid managed care

Insurers that administer Medicare Advantage plans or Medicaid managed care programs must comply with additional federal program rules — including benefit coverage standards, member communications, quality ratings, and network adequacy requirements — as outlined by CMS.

Consumer protection laws

Health insurers must follow laws designed to protect consumers, such as rules for transparent communication of benefits and costs, fair grievance and appeals processes, and timely handling of claims and denials.

Medical Device Manufacturers

From evolving standards to post-market surveillance, medical device manufacturers require significant resources, expertise, and robust systems to ensure patient safety and market access. Regology’s AI Agents take the pressure off by monitoring global updates, showing exactly what applies, and keeping a complete trail for audits. This way, manufacturers can speed up approvals, expand into new markets, and innovate without adding more risk.

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FDA regulations for devices

In the U.S., medical devices are strictly regulated by the FDA. Manufacturers must adhere to the FDA’s requirements for device classification, design controls, pre-market approvals or clearances, clinical testing, labeling, and post-market surveillance.

International device laws

Device makers need to satisfy regulatory regimes in different markets (such as the EU Medical Device Regulation (MDR) or other country-specific approvals). Each region may have distinct standards for device safety, performance, and registration, making global compliance a complex task.

Good Manufacturing Practices (GMP)

Adherence to GMP (also known as Quality System Regulations for medical devices) is mandatory. This ensures that devices are consistently produced and controlled according to quality standards, requiring thorough process controls, equipment calibration, and quality assurance procedures.

Data privacy requirements

Many modern devices and accompanying software collect patient data. Manufacturers must comply with data privacy laws (like GDPR in the EU or HIPAA in the US) when devices interface with protected health information to protect user data and prevent unauthorized access or breaches.

Anti-corruption compliance

Device companies must abide by anti-bribery laws, such as the FCPA and UK Bribery Act. For example, offering medical devices or incentives to healthcare providers must be void of any kickbacks or illicit inducements.

Environmental regulations

Manufacturers must follow environmental laws for handling and disposing of hazardous substances used in device production (e.g., certain chemicals, batteries) and comply with e-waste and recycling regulations for electronic medical devices.

Unique Device Identification (UDI)

Regulatory authorities (like the FDA) require devices to have a Unique Device Identifier for tracking and traceability. Compliance involves assigning and managing UDIs for each device model and ensuring they are registered in relevant databases.

Healthcare Administration

Administrators carry the weight of ensuring every department stays compliant, and it often feels like an uphill battle. Regology’s AI Agents help by keeping watch for new requirements, flagging risks early, and handling repetitive tasks automatically. That way, administrators don’t have to scramble to catch up—they can run their organizations with more clarity, confidence, and less stress.

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HIPAA compliance

Administrators must ensure that their organization fully complies with HIPAA’s privacy and security rules, implementing proper policies, training, and safeguards to protect patient health information across all departments.

Medicare and Medicaid program rules

If the facility bills Medicare or Medicaid, administrators need to maintain strict compliance with coding and billing regulations, quality reporting requirements, patient rights, and safety standards tied to these government programs.

The Joint Commission standards

To achieve and retain accreditation, healthcare organizations must continuously meet The Joint Commission’s quality and patient safety standards. Administrators play a key role in preparing for TJC surveys, correcting any deficiencies, and integrating TJC guidelines into daily operations.

OSHA regulations

Employers in healthcare must comply with Occupational Safety and Health Administration (OSHA) requirements to ensure a safe workplace. This includes protocols for handling biohazards, patient lifting procedures, employee injury reporting, and overall workplace health and safety standards.

Anti-discrimination laws

Healthcare administrators must enforce compliance with employment laws such as Title VII of the Civil Rights Act, the Americans with Disabilities Act (ADA), and the Age Discrimination in Employment Act (ADEA). This means implementing fair hiring practices, providing reasonable accommodations, and maintaining a workplace free of discrimination or harassment.

Keeping up with emerging regulations

New rules around healthcare delivery often emerge – for example, telehealth service regulations, data security mandates, or public health emergency directives. Administrators need agile processes to stay current with these changes and update internal policies accordingly.

Healthcare Technology

Health tech moves fast, but compliance moves just as quickly. Regology’s AI Agents help companies keep up by scanning privacy, security, and digital health requirements in real time, then highlighting what matters most. Compliance gets baked right into everyday operations, so teams can scale their solutions with trust and speed instead of being slowed down by uncertainty.

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FDA oversight of software

Certain medical software and mobile health applications may be regulated by the FDA as medical devices. Health tech providers must determine if their products fall under FDA jurisdiction and, if so, comply with guidelines on software safety, efficacy, and cybersecurity (as outlined in FDA guidance for Software as a Medical Device, for example).

HIPAA and health data laws

Companies handling protected health information on behalf of clients (e.g., cloud services for hospitals or apps for patients) must implement HIPAA-compliant safeguards and business associate agreements. Ensuring privacy and security of health data is a core legal obligation for health tech firms.

Cybersecurity regulations

Given the rising threat of cyber attacks, health tech providers often align with frameworks like NIST’s cybersecurity standards and may need to comply with laws like the Cybersecurity Information Sharing Act (CISA) when applicable. They must ensure robust security measures to protect systems from breaches, ransomware, and other attacks.

Data privacy regulations

Beyond health-specific laws, general data protection rules, such as the GDPR (applicable to any EU user data) or state privacy laws (like California’s CCPA), can apply. Health tech solutions must incorporate compliance for user consent, data usage, storage, and cross-border data transfers.

Anti-corruption and compliance

If operating globally, health tech companies must also be mindful of FCPA, UK Bribery Act, and similar laws to avoid any corrupt practices in sales or partnerships. This is especially pertinent when working with government-run healthcare or international markets.

Reimbursement and healthcare billing rules

Technology that facilitates healthcare services (e.g., telehealth platforms or billing software) needs to account for Medicare/Medicaid and insurance reimbursement regulations. Ensuring that coding, billing, and documentation functions meet regulatory standards is essential for client compliance.

Telehealth and cross-state rules

Caregiving Services

Caregiving organizations already have their hands full supporting people who depend on them. Regology’s AI Agents step in to track shifting requirements, send the right alerts to the right people, and keep records organized for audits. This gives providers peace of mind—less time spent worrying about compliance, and more time spent caring for those who need it most.

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State licensing

Caregiving organizations must comply with state regulations on licensing, caregiver qualifications, insurance requirements, and background checks for employees. These rules vary widely by region and service type.

Employment regulations

Caregiver services must adhere to labor laws, such as minimum wage and overtime requirements, as well as anti-discrimination and fair employment practices. Keeping up with federal and state labor regulations is essential to managing a caregiving workforce.

Medicare and Medicaid compliance

If the service is reimbursed by Medicare or Medicaid (for example, home health care under Medicare), it must meet the program’s conditions of participation, billing rules, care standards, and reporting requirements to receive funding.

HIPAA compliance

Care providers who handle patient health information (e.g., coordinating medical care or handling health records as part of their service) must protect that information in line with HIPAA’s privacy and security rules, even if they are not traditional healthcare facilities.

RISE Act and American Rescue Plan Act

The Recognize, Assist, Include, Support, and Engage Family Caregivers Act (RISE Act) mandated the development of a national strategy to support family caregivers. Meanwhile, the American Rescue Plan Act of 2021 provided funding and directives to bolster caregiving services impacted by the COVID-19 pandemic. Caregiving providers may need to adjust policies and leverage available support in response to these laws.

Consumer protection regulations

Businesses providing caregiving services must follow consumer protection and elder care laws—for example, clearly disclosing service contracts and fees, upholding standards of care, and ensuring truthful marketing practices.

Workers’ compensation

Like all employers, caregiving services must carry workers’ compensation insurance and comply with related regulations to protect employees who might be injured or fall ill on the job (especially important given the physical nature of caregiving work).

Frequently Asked Questions

What is Regology?

How does Regology work?

What industries does Regology support?

Is Regology suitable for small businesses?

How can I get started with Regology?

Getting started with Regology is easy! Simply fill out a short form to contact our team or request a platform demo, and we’ll be always available to assist you every step of the way.

Resources

Get Your Industry Insights Here

Compliance

August 11, 2025

Making Sense of the Noise: Staying Ahead of Compliance Changes

Compliance

August 5, 2025

From Spreadsheet to Strategy: Regulatory Compliance with Limited Resources

Banking

June 4, 2025

How Banks Will Be Handling Compliance in 2025

Ready to Learn More?

We would be happy to discuss your regulatory compliance needs. Contact our leading team of experts today.