Pharmaceuticals, Life Science and Health Technology
Hooper, Lundy & Bookman's Life Science and Health Technology Practice Group serves pharmaceutical, life science and health technology companies and investors, as well as health care providers facing technology legal issues.
We bring the firm's deep and broad understanding of health law to the operational issues of health technology companies, ranging from pharmaceutical giants to seed-stage medical device and software ventures. We help our clients ensure their products and operations comply with the health care regulatory landscape. In addition, our experience representing health care providers allows us to provide valuable insight to our pharmaceutical, life science and technology clients in their relationships with providers, government agencies and insurers.
Our proximity to the world's leading life science and health technology centers provide us a wealth of experience with the different sectors of life science and health technology. Our attorneys include veterans of the life science and health technology industry, who offer health care providers an insider's knowledge of the technology issues facing their operations.
We have participated in numerous corporate and commercial transactions, including mergers and acquisitions, strategic partnerships, venture capital and public financings, technology outsourcing agreements and licensing partnerships. We have advised investment and financing firms in their pharmaceutical, life science and health technology investing.
Pharmaceuticals and Life Sciences
For our pharmaceutical and life science clients, we counsel on a wide range of matters involving fraud and abuse, reimbursement, provider contracting, facility and biologics licensure, HIPAA, privacy and clinical trials. We offer unparalleled expertise in reimbursement law to help these clients obtain reimbursement coverage for their products.
We also apply our deep experience of fraud and abuse law to help clients implement and defend their sales and marketing strategies. We counsel clients in defense of audit findings, civil and criminal fraud and abuse allegations and in developing compliance policies. We have defended pharmaceutical manufacturers, wholesalers and retailers in numerous pricing investigations involving "average wholesale price," new drug pricing, "best price," generic drugs and innovator and noninnovator drugs. We have successfully defended clients against allegations of anti-kickback and False Claims Act violations and handled government information requests.
Information Technology and Software
Our information technology and software clients face many of the same fraud and abuse issues as pharmaceutical and life science companies in devising sales and marketing strategies that are both effective and defensible under fraud and abuse law. In addition, our information technology and software clients must demonstrate to health care customers that their products comply with current regulatory requirements and are adaptable in the face of regulatory changes. Our expertise with privacy, licensing and operational issues associated with health informatics and electronic health care helps our clients meet their customers' evolving needs.
Venture Capital, Private Equity and Investment Banking
Leading venture capital, private equity and investment banking firms rely on our health care expertise when evaluating investment choices and conducting due diligence. We have a deep understanding of how the health and life science regulatory environments influence business success. We use our expertise to provide practical legal advice to health technology and life science investors assessing opportunities in an increasingly complex regulatory environment.
Health Care Providers
Emerging technologies offer enormous opportunities and challenges for our health care provider clients. Our transactional and regulatory attorneys understand the complexities of technology licensing and compliance planning. We regularly provide counseling, drafting and negotiating services to providers entering into software and hardware licensing, marketing, billing, electronic record management and co-development agreements. Once providers begin to integrate new technologies, our regulatory experts assist clients with generating innovative compliance plans addressing evolving state and federal legal requirements, including reimbursement, HIPAA (privacy, security and electronic transmissions), licensing and Web issues. Our understanding of both the law and the technology relevant to these issues allows us to help our provider clients maximize the benefits of emerging technologies.
Pharmaceutical, Life Science and Health Technology Specialties:
- Fraud and abuse
- Reimbursement coverage
- HIPAA and privacy
- CLIA licensing
- Facility licensing
- Biologics licensing
- Provider contracting
- Technology and data licensing and transfer
- Medical informatics
- Electronic medical records
- Corporate compliance
- Clinical trials compliance
- Government investigations
- Pharmaceutical pricing
- Sector investing
Ahead to: Provider Operations