As a CSO have you ever suddenly found yourself being asked to sign a Non-Disclosure Agreement (NDA)? It can feel uncomfortable, so what’s it all about?

An NDA is a legally binding contract or agreement which establishes the extent to which confidential materials can be shared between the relevant parties. An NDA can be a mutual agreement which affects the sharing of materials in both directions or just in one direction.

When organisations do business together, it is often mutually beneficial to share information which is important to that relationship. For example, if a company comes to Safehand requesting advice on DCB 0129 we might need to know important technical information about their product. The organisation may be perfectly happy to share that with us, but they wouldn’t want to see it in the hands of their competitors – who of course might even be one of our existing customers.

So, to ease everyone’s mind and make business work, organisations construct NDAs to segregate information and formally agree what can and cannot be shared. But these contracts are not gagging orders. Most NDAs limit the distribution of the material which is shared but discussing that organisation more generally or resharing information which is otherwise in the public domain is nearly always permitted.

In many ways, NDAs establish a similar relationship to that which we have with our patients. We agree that we can discuss personal details between a doctor and patient but beyond that, consent is required. NDAs are commonplace in business – they oil the cogs of collaboration. At Safehand we probably sign one or two a week.

So how does this all relate to safety and DCB 0129/0160?

It’s not uncommon for a CSO to ask a supplier for their DCB 0129 materials only for them to suddenly receive an unexpected NDA. To the uninitiated this can feel a little uncomfortable, even threatening. We might ask ourselves, what is the supplier trying to hide? Might I now be unable to discuss the project with my colleagues? Am I legally exposed?

The first thing to note is that NDAs should be established between a supplier and a CSO’s organisation, not with the individual. It is highly likely that your organisation will have an established process for dealing with these and they may go to your legal department.

But why would a supplier want an NDA? Let’s think about what makes a good Safety Case. The DCB 0129/0160 standards remind us that a Safety Case must be compelling, comprehensible and valid. These qualities can only be established through the sharing of detail and evidence. That might be technical detail with regards to how the product works or sensitivities such as ongoing test issues or known incidents and concerns. A good supplier will want to share this information with you in the interests of safety and project success. But they are less likely to want to see this in the hands of a competitor or a journalist who might well publish a particular sentence out of context or in a misleading way.

If you’ve ever read a Safehand Safety Case you’ll notice the degree of honesty and candour with which they are constructed. If the product has safety-related shortcomings, these will be set out along with mitigations and/or a plan for their resolution. For the receiving healthcare organisations undertaking their DCB 0160 work, this is precious material indeed. But suppliers have to feel comfortable that they can share this data as part of a trusted partnership.

In fact, as a Trust CSO, NDAs can sometimes be your very best friend. Suppose you are a Trust potentially contracting with a new health IT system supplier. You might want to see their Hazard Log and Safety Case before you sign on the dotted line with them – a perfectly reasonable request. But the supplier indicates that the material is Commercial in Confidence and can therefore only be shared after contract sign. You are in a chicken and egg situation. An NDA is a much simpler document than the wider commercial contract and it is perfectly reasonable to use such a vehicle as the basis for trusted sharing of the DCB 0129 documentation prior to contract sign.

A question which often arises is, if we have an NDA in place, does that limit a Trust’s CSO from being able to discuss the issue with a neighbouring Trust? In reality, you would need to look carefully at the terms of the NDA and any wider commercial contract. However, in most cases the NDA will relate only to the documentation which has been shared with you. If you identify a system issue, knowledge of that issue is potentially your information, not that of your supplier so you may well be perfectly at liberty to discuss that with another Trust.

In summary, NDAs are not to be feared and the use of them in safety management across all safety-critical industries is commonplace. What is undisputed is that sharing of safety information benefits all parties and if an NDA provides a trusted comfort blanket for organisations to have honest conversations, then that can only be of benefit to everyone.

Note that nothing in this post constitutes legal advice. You should consult a legal professional for any queries around NDAs or commercial contracts.