The best way to select a healthcare lawyer or FDA attorney (or FDA regulatory consultant) for legal advice about your health and wellness service, practice, facility, or product, is to follow this four-step process.
1. Look for an attorney with specific healthcare and FDA legal experience.
Find a healthcare or FDA lawyer who has specific experience in healthcare and FDA matters.
You can find out the experience a healthcare or FDA attorney has by carefully reviewing their website.
Many attorneys say they practice healthcare law, but their healthcare experience is in fact limited. For example, an attorney may say he or she does healthcare law but be a litigator who has represented only one healthcare client in one business dispute. Healthcare and FDA law is highly specialized. A good healthcare or FDA attorney is a veteran of many battles in the field. That attorney understands the complexity of legal and regulatory issues in the health and wellness field, and the importance of solid legal advice in a strategic way that helps you build your dream.
Your healthcare or FDA lawyer should be sophisticated, and have a thorough grounding in many legal issues facing health and wellness practices, and companies. You can assess this by looking at the legal services and experience the attorney showcases on the law firm website. Simply saying that one practices healthcare law is not enough; on the other, having dozens if not hundreds of blog posts, over time, demonstrates a consistent commitment to representing clients in the health and wellness industries.
2. Check that your healthcare and FDA attorney has broad knowledge of applicable law.
Assess your healthcare lawyer or FDA regulatory attorney’s knowledge of multiple areas of healthcare and FDA law.
As we’ve said, healthcare law is a specialized legal arena, and yet healthcare law also contains many sub-specialized areas of law within it. Because many legal and regulatory issues can coincide, it is important to choose a lawyer who has the birds’ eye view of a general counsel, and who can analyze in many different directions at once.
Healthcare law is unlike many other areas of law that are more discrete. In the health and wellness industries, many situations require that your healthcare or FDA lawyer understand and be able to navigate complex, nuanced legal rules across many areas.
This can include, for example, knowledge of the way that legal issues intersect, when dealing with:
- corporate practice of medicine, kickbacks, Stark, and fee-splitting
- healthcare practitioner licensing issues, including scope of practice of non-MD providers
- medical board discipline and psychology or nutrition board discipline
- Medicare and private insurance contracts
- telemedicine, mobile medical apps, and online health and wellness
- HIPAAand privacy and security of protected health information
- malpractice liability and informed consent practices
- medical device, cosmetics, and dietary supplement legal rules
- state and national healthcare politics and policy, and health and wellness industry strategies and trends
- alternative, complementary, and integrative medicine
- stem cell regulation and laws governing emerging therapies, from stem cell injections to cord blood banking
- concierge medicine and hybrid practice models
- energy medicine and future technologies, including robotics and artificial intelligence
- everything from bioethics to biopharma
3. Find a healthcare or FDA lawyer with stand-out legal experience and stellar credentials.
Is your healthcare and FDA lawyer someone whose experience, skill and expertise stand out above others? Does your attorney have stellar credentials – such as big-firm experience, academic teaching and publishing, awards, and reputation in the community?
If so, you are likely to get efficient and effective legal service. Look to the attorney’s overall experience and the data on the website to get a sense. Call and talk to the healthcare or FDA attorney for a few minutes to get a sense of how that person’s professional mind works.
The hourly rate is no indication of the lawyer’s efficiency and effectiveness. A good lawyer is thorough, comprehensive, and competent in many areas. That healthcare attorney will give you good value as he or she renders counsel. Good advice takes experience, research, and analytical super-power. It’s better to get solid legal advice upfront, especially if you are a health start-up venture or putting together a medical device, cosmetic, dietary supplement, or OTC drug which puts you at risk of FDA or FTC enforcement, or a practice that trigger medical board scrutiny.
4. Be sure you like your healthcare or FDA attorney.
Does your healthcare and FDA lawyer have a calm demeanor and a good personality? Lawyers sometimes look, sound and feel like robots (not the latest AI version, either). Find a lawyer who comes across as personable and approachable. Your FDA regulatory consultant or healthcare attorney may have stellar credentials, but should not be a stuffed shirt. Find someone who not only gives you clear legal advice, but also relates to you in a personal manner. It’s okay to smile and enjoy your legal consultation, even as you get valuable counsel for your business or healthcare project.
These four steps will help you select the right healthcare or FDA lawyer.