What does the King's Speech mean for MedTech?

One of the key areas of focus is regulatory reform and in particular attempts to ease what is felt to be an overly rigid and constraining approach (resulting in less innovation making it through to market). These proposals are not specific to MedTech, or even health more broadly, but certainly have implications for both. Notably, the Regulating for Growth Bill will include the following proposals:

• A statutory 'growth' duty on regulators, requiring them to actively promote innovation alongside their broader regulatory duties and powers. The Information Commissioner is already subject to such a duty as it was introduced in the Data Use and Access Act 2025 (DUAA), but this prompted considerable debate, especially in the House of Lords, about the clear balance and trade-off between growth and safety. This is an interesting line to tread, not least given the essential role that regulators such as the Medicines and Healthcare Products Regulatory Agency (MHRA), Care Quality Commission (CQC) and others play in ensuring patient safety, and we will have to wait and see how the duty is expressed when further details are released. It is also noteworthy that the duty will be accompanied by powers for ministers to issue strategic steers to regulators on how to meet the duty, as well as reporting requirements for compliance to be assessed against. This may well raise concerns of direct political interference with regulation. However, it could also be seen as a mechanism for getting new technology innovations more quickly to market, especially in sectors like independent healthcare which have an agility more suited to be able to do this; and

• Cross-economy 'sandboxes' to create more benign conditions for testing new technologies. This was described in a background briefing note produced by the Government as follows: “The intention is to enable controlled, live‑market trials where existing laws can be modified or suspended to allow experimentation in relation to technologies such as medicines, autonomous maritime and defence technology, AI and other fast‑growing technologies”. Regulatory sandboxes are not new as they have been run by several regulators for many years. This new proposal allows for the underlying legal and/or regulatory compliance obligations, which would otherwise apply, to be relaxed. In a health context, this will mean balancing the need to safeguard patient safety, especially when it comes to initiatives involving, say, diagnostics while enabling innovation. Not only can new medicines and medical devices be tested but the flexibility of the sandbox model may also benefit future regulatory pathways.

Both of those proposals will be included in the Regulating for Growth Bill, which is expected to be introduced to Parliament at some point this year (we will provide a more detailed update on the specific proposals at that stage). 

In addition to the above, we do also now have the Health Bill which deals with a broad range of matters for the future of the health sector - for an overview of the Health Bill, see our recent article here. Clearly the manner in which health services will be planned and delivered going forward will be of interest to those operating in the MedTech sector, but the Health Bill has fairly limited direct provisions relating to MedTech. That said, there are a couple of specific areas we have identified that may be of potential interest:

• The Single Patient Record (SPR) will be enabled by introducing a duty on health and social care providers (both public and independent sector) to share patient information into the SPR. The details of this will be set out in regulations. Those regulations can provide that any patient information shared in consequence is done in compliance with duties of confidentiality (seemingly to avoid any obstructive attempts to cite information law obligations as being a blocker to information sharing). This is quite a narrow provision in itself, as it relates specifically to the SPR, but may be of relevance to those who provide treatment as part of the NHS and/or record-keeping systems to NHS customers as they may well hold information falling within the scope of regulations. It is also worth bearing in mind the new powers under the DUAA relating to compatibility of IT systems in the NHS as they could, in principle, be used in due course to ensure that any providers with potentially relevant information design their systems compatibly with the SPR; and

• The Health Bill sets out some of the detail for the abolition of NHS England, notably setting out the commissioning functions which will be transferred to Integrated Care Boards (ICBs). They include commissioning of primary care, dental, ophthalmic and pharmaceutical services and so MedTech focused on those particular service lines arguably has more, albeit smaller, opportunities arising out of a regional rather than national approach. The Health Bill also proposes to merge the functions of the Health Services Safety Investigations Body (HSSIB) into the CQC. This may have a bearing in the future for how investigations into those who undertake CQC-regulated work are complying with their regulatory obligations.

We are still light on detail for the more granular implications of all of the above, whether that is because we will need to see the precise proposed form of legislation (whether that be primary legislation to enact broader regulatory reform or secondary legislation in the form of regulations to give effect to the Health Bill). We will monitor these developments closely and provide further updates in due course.