Yes, absolutely there are very different rules that you have to follow for healthcare products. It mostly boils down to what you are claiming, and what the 'class' of your product is as defined by the FDA.

You have to go through an extensive process to get certain healthcare products approved by the FDA. And even when approved, it's only approved with certain restrictions on how you can market it.

I've worked with two startups on getting products through FDA, and worked with them on how to legally market their products before FDA approval (i.e. how to correctly abide by the restrictions while still being able to market).

If you'd like to discuss the restrictions more with respect to your specific product let me know,

all the best,

Lee

I probably know more about this than anybody. I have been working in the business of healthcare marketing for many years now.

There are some differences, but I will not focus on the FDA, etc. All businesses have their Big Brother. The real difference is consumer trust and how do you build that trust. This depends on several factors including what type of product you are selling, who are your competitors and the advertising tone deaf of your market. Have they already been bombarded with similar products? If so, you will have to use a different path to get to them.

The secret to success: I have had the pleasure of knowing and working with some of the biggest names in business, celebrities, actors, entrepreneurs, business people, and companies from startup to billion dollar operations. The number one reason for their success is doing what they know and love while doing it in new, creative, and innovative ways.

Best of luck,
Take massive action and never give up.
Michael

Michael Irvin, MBA, RN

Data security and privacy controls are things to consider carefully. Depending on the jurisdiction you fall in, there can even be legislation that you need to follow (e.g. HIPAA).

Having a strong data protection and a clear privacy statement is not only good for your peace of mind, it also demonstrates that you care about your customers data and set you apart from other healthcare businesses. Here in the Europe there are strong directives for protecting private identifiable personal data and especially anything related to healthcare.

Yes, I think in general you should think about "government," "professional society" and "industry" regulations or standards. For instance, take an MRI scan. The government, i.e., CMS, will approve an MRI for payment, a professional society such as the American College of Radiology may need to be the entity to develop what the definition of delivering an MRI is, and an industry entity may define specific parameters around what the technical pieces are for an MRI. The takehome message is you should keep this framework of government, professional society and industry in mind when communicating messages around healthcare. Each may have a different take on the service/product.