Our healthcare regulatory practice provides legal support for healthcare providers and organizations, focusing on compliance with regulations and addressing legal challenges.
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Healthcare Regulatory Practices
Practice Areas
Healthcare Regulatory Practices - Overview
Services Offered:
- Healthcare Compliance Program Development
- Healthcare Risk Management
- HIPAA Compliance
- Healthcare Data Privacy and Security
- Healthcare Regulatory Enforcement Defense
- Healthcare Contract Disputes and Litigation
- Digital Health Innovation
1.Healthcare Compliance Program Development
Description
- Designing, implementing, and maintaining comprehensive compliance programs tailored to healthcare providers' needs.
Services Provided
- Conducting compliance assessments and gap analyses.
- Drafting and updating policies, procedures, and codes of conduct.
- Providing compliance training for employees and management.
- Establishing monitoring and auditing protocols.
- Advising on regulatory changes and updates (e.g., HIPAA, HITECH Act).
2.Healthcare Risk Management
Description
- Identifying, assessing, and managing legal and regulatory risks inherent in healthcare operations.
Services Provided
- Developing risk assessment frameworks and risk mitigation strategies.
- Conducting risk assessments related to compliance, operational, and transactional matters.
- Advising on crisis management and response strategies for regulatory issues.
3.HIPAA Compliance
Description
- Ensuring compliance with the Health Insurance Portability and Accountability Act (HIPAA) and related data privacy laws.
Services Provided
- Developing HIPAA compliance programs, policies, and procedures.
- Conducting HIPAA privacy and security risk assessments.
- Responding to breaches and assisting with breach notification obligations.
4.Healthcare Data Privacy & Security
Description
- Addressing data privacy and security issues specific to healthcare organizations.
Services Provided
- Advising on compliance with state and federal data protection laws (e.g., GDPR, CCPA).
- Drafting data use agreements and privacy policies.
- Conducting training on data privacy and security best practices.
5.Healthcare Regulatory Enforcement Defense
Description
- Representing healthcare entities in investigations and enforcement actions by regulatory agencies.
Services Provided
- Defending against allegations of healthcare fraud, abuse, and regulatory violations.
- Handling administrative hearings and appeals.
- Negotiating settlements and remedial actions with regulatory authorities.
6.Healthcare Contract Disputes & Litigation
Description
- Resolving contractual disputes and litigation involving healthcare providers and entities.
Services Provided
- Litigating disputes arising from provider agreements, reimbursement issues, and vendor contracts.
- Representing clients in arbitration and mediation proceedings.
- Advising on litigation avoidance strategies and alternative dispute resolution methods.
7.Digital Health Innovation
Description
- Navigating regulatory requirements for digital health products and services.
Services Provided
- Counseling on FDA regulations for medical devices and digital health technologies.
- Drafting terms of use and privacy policies for healthcare apps and platforms.
- Advising on intellectual property protection and technology licensing.
Case Example
We assisted a healthcare provider in navigating complex regulatory requirements for accreditation, ensuring compliance and securing the necessary certifications for operation.