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Software as a Medical Device or SaMD is a rapidly evolving field set to get bigger shortly. The pace of advancing technology is rapid, and the opportunities for financial gains are considerable.

But a key element that must always be front and center is compliance. Compliance with safety regulations, laws, and governmental limits on what can and can not be done. This is even more true when the SaMD collects and stores patient data, with the European markets being especially sensitive to this. What should an investor keep in mind? Let’s take a look at some of these compliances, and how these affect the SaMd market in Europe.

SaMD, Data, and Compliance

SaMD receives input data which, through algorithms and AI, it organizes into

  • Health Profiles
  • A Diagnosis
  • Health Risk Assessments
  • Recommendations for Treatment
  • A Meta-Image of Patient Health

This initial data may come from

  • A Wearable Smart Device
  • An X-Ray
  • An MRI
  • A List of Patient Symptoms.

In Europe, SaMD is often referred to as Medical Device Software (MDSW) and is overseen by a separate set of European Union regulations which are still in the process of being written up, agreed on, and implemented within Europe.

One recently drafted regulation is EU 2017 / 745, which prioritizes product safety, patient data protection, and full transparency regarding how the software works and how data is used or stored. This regulation leaves the specifics of determining whether or not a device is compliant up to each member state, but a few broad takeaways can be gleaned.

Key Points To Consider

One thing for investors to consider is the great importance that the European Union places on patient privacy and how digital data is handled. This is something I’ve often encountered in dealings abroad. Indeed, strict EU regulations have made it hard for some social media companies to introduce their products there.

When aiming to launch a SaMD product in the EU, consider…

  • Data must stay within the EU, and may not be transferred abroad
  • Patient data may not be sold or used for commercial purposes
  • Patients may request their private medical data to be deleted
  • Privacy and data laws may change as the product is being developed

Ensuring compliance in the European Union will come down to a keen awareness of how seriously data privacy is taken in Europe. A fluent literacy in EU law is also vital. Leaving everything to your legal department and refusing to consider EU compliance laws is irresponsible business management.

Communication Abroad is Vital

Be willing to communicate with lawyers and data rights organizations abroad. The more you know, the better a chance at success you’ll have. I’ve seen some investors express excessive optimism simply because a product solved a problem. Don’t expect the novelty or efficiency of a SaMD product to carry itself. If your data practices are not up to snuff, the ship won’t sail.

Be willing to communicate with European

  • Lawyers
  • Data Privacy Experts
  • Businessmen
  • Medical Investors

for a better sense of what to do and how to keep SaMD compliant. Beating American competition to the punch will take foresight, hard work, and literacy in evolving law,

but the fiscal rewards can be considerable.

So how can you prepare to launch a SaMD product in Europe? Keep the perspective of customer privacy in mind, 100%. Too often, American investors are immediately thinking of profitability and brokerage before anything else. This mindset works in the U.S. but can cost you overseas markets. Take the perspective of the patient with data concerns. Remember, your goal is to launch successfully and profit off of the software. To be truly successful, you’ll have to set aside some of the capital-heavy thinking

that propels much American data handling. Instead, focus on ahead-of-the-curve data safety and be willing to have no access to patient data or metadata Stateside. The benefits will be a lucrative new field and years of trust with European markets. Ask yourself

  • Does this go above and beyond with data privacy?
  • Would a privacy-focused patient or hospital use my software?
  • Am I considering long-term investments or short-term gains?

Keep these thoughts at the forefront as you develop the product, and you’ll do well.

Final Thoughts

Compliance with European data laws can be a challenge for American companies. Software as Medical Devices is an emerging technology that has some excellent applications, but handling patient data in Europe is complex.

As an investor, understand that European patient data privacy laws are stringent. You won’t have access to patient data Stateside. You must also take care that the software you’re developing does not unduly share sensitive information abroad with commercial third parties.

The rewards for complying with existing EU law and thinking ahead can be considerable. Be willing to learn, comply, and do away with the data brokerage mindset of American software policy. Think long-term, and you can crush the competition.

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