Telemedicine,
Legal Excellence
FDA-regulated sites must navigate telemedicine requirements by
ensuring compliance with regulatory, legal, and privacy standards.
Our services include regulatory advising, privacy solutions,
telehealth policy development, and contract support.
Telemedicine
Regulatory Advisory Services
Privacy and Data Security
Contract Review and Drafting
Regulatory Advisory Services
Comprehensive compliance guidance for telemedicine operations
Facilities offering telemedicine services must comply with a variety of state and federal issues including licensing, informed consent issues, credentialing, and privacy concerns. The Kulkarni law firm reviews your companies specific requirements to ensure that they meet concerns .
Documentation
- Compliance Gap Analysis Report
- State-Specific Regulation Overviews
- Informed consent form development
Services
- Compliance Gap Analysis
- State and Federal Regulation Advisory
- Licensing and Credentialing Support
Privacy and Data Security
Ensuring compliance with privacy laws and data protection requirements
FDA-regulated companies may need to comply with privacy and data security laws like HIPAA, CMEA, FTC Act, wiretapping laws and more. The Kulkarni Law Firm is here to help.
Documentation
- HIPAA Compliance Policies and Procedures
- Risk Assessment Reports for Data Security
- Business Associate Agreements (BAAs)
Services
- Privacy Policy Development
- Data Security Audits
- Incident Response Planning
Contract Review and Drafting
Expert legal support for telehealth agreements and partnerships
Life science companies navigate telehealth contracts, ensuring compliance with diverse requirements while protecting your interests. Our services include drafting, reviewing, and negotiating telehealth agreements.
Documentation
- Telehealth Service Agreements
- Vendor Contracts and Licensing Agreements
- Partnership and Collaboration Agreements
Services
- Contract Drafting
- Risk Mitigation Analysis
- Negotiation Support
Why Legal Representation Matters
Legal representation in telemedicine for life science companies,
particularly in clinical research, is crucial for several reasons:
Attorney-Client Privilege
Attorney-client privilege keeps discussions safer than regular confidentiality.
Comprehensive Guidance
Addresses not only FDA regulations but also legal considerations, such as privacy laws, OIG, DOJ requirements, and state-specific telehealth mandates.
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.
