DigitalHealth.London’s Programme Director, Yinka Makinde, reflects on developments in the digital health space, including the appointment of a new NHS England (London) Medical Director for Primary Care and Digital Transformation; new funding opportunities; and a growing sense of optimism for future innovation.

This month I wanted to pause a little, to reflect on the last few weeks, as a lot has happened outside of DH.L, but in the broader ecosystem to help strengthen our chances of being able to realise our own vision – which is to accelerate the adoption of technology across the health and care sector. The appointment of Dr Jonty Heaversedge, new NHS England (London) Medical Director for Primary Care and Digital Transformation; the recent £86 million fund for medicine and technology SMEs (with £35 million allocated to a Digital Health Technology Catalyst); and the Innovation Technology Payment.

These three milestones have driven up optimism amongst those that work in, and supply the health care sector. We are seeing leadership and the funding to back the transformation agenda.

But what’s needed next? Four ideas come to mind:

  1. A more robust and scalable way to identify, define and feedback ‘need’ in the system
  2. A larger network of accredited evaluation sites where innovators can go to test out their solutions
  3. A trusted mechanism of scouting the market place for suitable innovations
  4. A clearly defined set of standards that technology developers can build against to ensure they are building for safety, scale and sustainability.

I am watching with interest the pace at which we will start to see emerging collaborations that will help to make these ideas a reality.

As a side note, this is an interesting news story from the USA. On Thursday the Food and Drug Administration (FDA) announced the launch of its “Software Pre-certification (PreCert) Pilot Program”, a voluntary programme that will focus not on particular products but on firms and developers. If the FDA is satisfied that a firm is responsible and safe in its development, then it won’t need to regulate each product from that firm. This is a tailored approach to regulating technology, quite dissimilar to previous FDA regulatory ventures. The new FDA Commissioner Dr. Scott Gottlieb stated that “Pre-certified companies could submit less information to us than is currently required before marketing a new digital health tool. In some cases, pre-certified companies could not submit a pre-market submission at all. In those cases, the pre-certified company could launch a new product and immediately begin post-market data collection.”

Applications for the new PreCert pilot open on 1 August. Initial participants in the pilot will range from small startups to large companies that develop both high- and low-risk software products that are devices. Including medical product manufacturers as well as non-traditional software developers.

For more information on this, and for details of an upcoming webinar being hosted on 1 August, read here. There will be some valuable learnings for the UK from this.