Legal considerations for health tech
Have you created the next great health tech solution but unsure of what legal considerations you need to be aware of? IT Lawyers Brisbane is here to help!
There is no denying that the healthcare technology industry is booming, even the Australian Financial Review agrees that “a technology-led revolution in medicine is fast approaching”. If you’re part of this fast-growing health tech space, you’ve probably landed here because you are trying to navigate a range of corporate, compliance and contractual matters.
We here are IT Lawyers Brisbane are excited to see the expansion of health tech and, from having helped numerous health tech companies navigate their legal needs, we’ve put together this little guide on Legal Considerations for Health Tech to help you get started!
Legal considerations for health tech: Privacy
Are you aware of any privacy obligations you may have?
The number one legal consideration for health tech companies should be around personal information and privacy. Considering the sensitivity of the type of information you may hold about individuals, there is both a consumer expectation of stringent privacy policies, but also potentially a legal requirement.
If your company holds health information of individuals, you will likely fall within Australian Privacy Laws which require you to take certain measures when handling such information. One such measure is in having a Privacy Policy which clearly articulates your practices of how you handle personal information. This includes incorporating any access to individuals’ My Health Records and if and how you transfer data offshore.
Legal considerations for health tech: Cybersecurity
Do you know your legal obligations if you have a data breach?
As we’ve highlighted, recognising and responding to your privacy obligations is a key legal consideration for health tech. One of these obligations includes how you should respond where you’ve had a potential data breach. Where you are an entity that falls within Australian Privacy Laws, you may have an obligation to notify the Office of the Australian Information Commissioner (OAIC) and the individuals affected, where you have a “notifiable data breach”. There are significant fines where you fail to comply and also specific requirements on what is included in the notification. Furthermore, a failure to satisfy community standards may pose a significant risk to your reputation.
Now there are a number of factors which determine a data breach as a “notifiable data breach”. That is where a technology lawyer, like IT Lawyers Brisbane, can help you navigate this determination and potentially save you from a costly mistake and help mitigate reputational risks.
Legal considerations for health tech: Terms of Use
Do you know if your terms of use are legally compliant and appropriately address your needs?
Well drafted Terms of Use are imperative for any tech product, especially for health tech. Terms of Use can provide Intellectual Property protection, limit your liability, outline client rights and responsibilities and also evidence compliance with the Australian Consumer Law. This is a particularly important legal consideration for health tech where you may be making claims as to the health results your product can help achieve. Terms of Use can also help specify when and how agreements are formed, how payments are handled and also how agreements may automatically renew or be terminated.
Whether your health tech solution is a physical product, Software-as-a-Service or a combination of both, IT Lawyers Brisbane has extensive experience in drafting custom Terms of Use that address your particular business model and product specifications.
Legal considerations for health tech: Intellectual Property
Have you ensured that your intellectual property is adequately protected?
Your Intellectual Property (IP) may well be one of your most, if not the most, valuable asset you hold. A core legal consideration for health tech is therefore ensuring you have in place the necessary IP Protection measures. This can be vital to the success and longevity of your business and may also have implication on the value of your business. Persons investing in your business or potential buyers will typically concern themselves with the ownership and protection afforded to your IP.
There are a number of ways you can protect your IP including:
- Specific Corporate Structuring.
- Written IP Assignment Deeds with any developers you engage.
- Having Confidentiality Agreements with any entities you share your idea with (including potential customers or distributors).
Having these components in place can put your health tech business well on the way towards protecting your IP.
Legal considerations for health tech: Distribution Agreement
Are you considering entering into a distribution arrangement for your product?
A common need we see with our health tech clients is to have in place Distribution Agreements for their product. Whether you are distributing to retail outlets, service providers or resellers either offshore or within Australia, having a well-tailored Distribution Agreement is an important legal consideration for health tech.
The types of elements such a Distribution Agreement should address include:
- Pricing model.
- Price list and how often it is updated.
- Payment terms.
- Product delivery.
- Any associated marketing material, who is to produce it and how it is to be handled.
- Any limitations associated with the sale of the product.
- Allowing or disallowing sub-distributors.
It is also important that your Distribution Agreement doesn’t become subject to some of the common pitfalls we see such as creating anti-competitive behaviour, falling within the franchise code, providing insufficient detail or contradicting consumer guarantees.
Legal considerations for health tech: In summary…
So, in summary, there are a lot of legal considerations you need to be aware of if are starting or running a health tech company. From privacy to cybersecurity, terms of use, intellectual property and distribution agreements, being aware of these are just the starting points. From here, engaging a technology, commercial and corporate lawyer experienced with the health tech industry can help you put into place the policies and agreements necessary to ensure you cover these legal considerations for health tech.
IT Lawyers Brisbane can provide to you a free initial consultation to discuss your unique product and help you understand what your specific legal needs are.
