Medical Practices,
Legal Excellence
Supporting medical practices with tailored legal solutions to ensure
compliance, mitigate risks, and enable operational success.
Medical Practices
False Claims and Anti-Kickback Statute
Contract Support
Telemedicine Regulations
Patient Privacy Laws
False Claims and Anti-Kickback Statute
Navigate complex federal healthcare regulations
We help medical practices navigate complex federal healthcare regulations by identifying and mitigating risks related to improper claims and financial arrangements.
Documentation
- Compliance Program Policy Manual
- Contract Risk Assessment Report
- Self-Audit Checklist
Services
- Tailored Compliance Program Development
- Contract Review and Risk Evaluation
- Internal Process Audits
Contract Support
Ensure fair, balanced agreements aligned with your interests
Sites must ensure that clinical trial agreements and other agreements are fair, balanced, and aligned with your best interests. The Kulkarni Law Firm advises clients with these interests
Documentation
- Clinical Trial Agreements (CTAs)
- Vendor Contracts
- Material Transfer Agreements (MTAs)
Services
- Contract Negotiation Support
- Confidentiality and IP Protection
- Contract Lifecycle Management
Telemedicine Regulations
Navigate the evolving landscape of telehealth compliance
We help navigate the evolving landscape of telemedicine regulations, ensuring legal compliance across state lines while prioritizing patient care.
Documentation
- Telemedicine Compliance Manual
- Patient Consent Forms
- Licensing Review Report
Services
- Legal guidance for telehealth compliance
- Draft and review telemedicine contracts
- Audits and investigations
Patient Privacy Laws
Comply with federal and state medical privacy regulations
Healthcare providers must not only comply with federal medical privacy laws like HIPAA, but may also need to comply with state specific medical privacy laws like CMEA. Furthermore marketing may impact other privacy laws including CCPA/ CPRA, state wiretapping laws and more.
Documentation
- Privacy and Marketing Policies
- Website Terms and Conditions
- Data Processing Agreements (DPAs)
Services
- Privacy Impact Assessments (PIAs)
- Data Subject Rights Management
Why Legal Representation Matters
Compliance with legal and regulatory requirements is essential
for clinical research practices in physician offices.
Attorney-Client Privilege
Ensures critical discussions and sensitive information are protected beyond the scope of standard confidentiality agreements.
Comprehensive Legal Guidance
Encompasses adherence to FDA guidelines, privacy laws, and evolving regulatory frameworks from agencies such as the OIG and DOJ.
Compliance Support
An attorney ensures compliance, protects your interests, and supports innovation.
Why Choose the
Kulkarni Law Firm?
Contact the Kulkarni Law Firm for practical and legal guidance.
Experience
20+ years as an attorney, pharmacist, and compliance expert.
Expertise
Author, podcaster, and educator on clinical research.
Education
Teaches at Drexel, Temple, and other universities.
