Healthcare Information Technology

As the complexity of our healthcare system increases, so does the need for cost-effective, sustainable, and innovative technological solutions. We counsel companies providing and receiving those solutions, drawing upon our deep experience in representing clients in the technology industry and in the healthcare and life sciences industries, where we are recognized nationally for our expertise.

Our industry-specific experience ranges across companies and projects, including:

• Health information exchange
• Cloud-based storage and services delivery
• Clinical documentation and decision support
• Electronic medical records and electronic health records
• Mobile health (mHealth) applications
• Telemedicine
• Disaster recovery and data breach
• Privacy and security
• Revenue cycle management
• Business intelligence
• Research and data analytics and visualization

In advising healthcare technology clients, we draw upon cross-disciplinary expertise in primary areas of need that include the following:

Regulatory and Compliance Matters

We counsel clients in structuring significant business transactions to comply with complex federal and state statutes and regulations affecting the healthcare technology industry. We have extensive practical experience in developing and implementing individually-tailored compliance programs for our clients and in providing related training. We also have substantial experience dealing with regulatory audits and investigations. Clients rely on our advice to meet important federal and state healthcare and data privacy regulatory requirements, including:

• HIPAA and other privacy rules and compliance
• Security rules and compliance
• Data breach response
• ARRA and HITECH Acts, including Meaningful Use requirements
• Anti-kickback statutes, Stark Law, and False Claims Act
• Sunshine Laws
• Foreign privacy law compliance
• FDA, including 510(k) and pre-market approval clearance process, marketing and promotion rules, medical devices, and mobile apps
• Clinical research, including Institutional Review Board requirements and provider/sponsor arrangements
• Antitrust compliance

Corporate and Operational Advice

• Business formations geared to the special needs of healthcare technology companies
• Electronic health record (EHR) and electronic medical record (EMR) issues and related contract negotiation
• Business tax planning
• E-Commerce, including website establishment and maintenance and electronic payment systems
• IPOs, private venture capital and bank, and other institutional debt financings
• Structuring and negotiating equity and debt infusions
• Structuring mergers, acquisitions, and divestitures
• Affiliations, Research Collaborations, and Development Agreements
• Licensing, Distribution, OEM, and VAR Agreements
• Negotiating joint ventures, alliances, and strategic partnerships
• Intellectual property counseling and trademark, patent, and copyright filings
• Negotiation and development of employee and independent contractor agreements, confidentiality and non-disclosure agreements, restrictive covenant agreements, and work-for-hire agreements
• Structuring employee stock and stock option plans, shareholder agreements, employment agreements, compensation and benefit plans
• Preparation of internal and external agreements to limit the risks associated with data security and breach

Litigation

We have successfully litigated significant cases in state and federal trial and appellate courts across the country, covering virtually every aspect of healthcare and technology law, including:

• Intellectual property and contract disputes over healthcare technology
• False advertising, trademark, and other unfair competition litigation
• Trade secret protection and prosecution, including seeking emergency injunctive relief against threatened theft of trade secrets and confidential business information
• Software license disputes
• Antitrust litigation
• Data breach and security-related litigation

We provide our healthcare technology clients with timely, creative, and effective advice and guidance, working from key office locations in Atlanta, the center of a thriving healthcare IT market, and in Washington, D.C., the locus of continuing regulatory change.