Valant lawyers assist health care practitioners and entities with health care regulations, licensing and practice issues, privacy and confidentiality/HIPAA, sale acquisition of practice, telemedicine and e-wellness, kickback rules, bioethics, and Medicare/Medicaid regulations. By drawing on our talents and experiences, clients will be aware of nuances of health law and will comply with the requirements of state and federal fraud and abuse laws and other statutory and regulatory challenges unique to health care professional entities.
We also promote, protect, and defend products made by industries regulated by the U.S. Food and Drug Administration (FDA). The products we help get to market include foods, pharmaceuticals, medical devices, dietary supplements, and cosmetics. In addition, we have a very comprehensive practice in the regulation of packaging materials for food and cosmetics and other food-contact articles. Aliant lawyers represent clients in addressing all issues relating to these products, including the suitability of their composition, inspection of manufacturing facilities, labeling and advertising, recall procedures, quality assurance programs, and appropriate responses to consumer complaints and tampering incidents. We also have substantial experience conducting “due diligence” audits of marketed products, labeling, advertising claims, and manufacturing operations, both for the clients’ internal control purposes and as part of product line or corporate acquisitions.
Here are some examples of how our lawyers assist clients:
- Legal Review & Advice Relating to the Practice.
- Claims and/or guarantees made in the practice/ FTC/FDA Disclaimer for main website and marketing materials.
- Use of any potential “medical devices” under the federal Food, Drug & Cosmetic Act.
- Analysis of Stark and federal anti-kickback issues for illegal business arrangements (such as splitting fees between MD, Center and practitioner).
- Contract between MD/DO and Center/Clinic/Practice/Spa.
- Legal and contractual issues involving service as medical director.
- Contract between non-medical Practitioner and Center/Clinic/Practice/Spa.
- Medical supervision issues (e.g., Botox, spa therapies).
- Privacy Form (non-HIPAA, mirror form; or HIPAA manual if billing electronically).
- HIPAA Manual and Forms (including Business Associate form).
- CLIA advice (chemical services, lab tests, blood fluids); scope of practice and standard of care issues regarding lab tests.
- Physician Employment Agreements
- Management Services Organizations (MSO) Agreements