Schermafbeelding 2012-12-29 om 13.25.01The end of the year is upon us, and I’d like to take the opportunity to wish the readers of this blog all the best for the new year, a new year with lots of exciting developments ahead. This post will not be the usual regulatory and legal analysis of rules, but something more forward looking and analyzing how the law will deal with developments that I think are particularly interesting:

    1. Apps will become more prevalent in clinical use and will be used more and more for higher for higher risk operations, as the overview of most innovative medical apps of 2012 on shows. The European Commission is currently in the process of overhauling the MEDDEV on standalone software, announced guidance on apps and proposed mobile computing platform specific essential requirements in the newly proposed EU Medical Devices Regulation (MDR). The new accessories rule proposed will also bring a lot of peripheral apps within the scope of the MDR).
    2. As medical devices take their place in the internet of things or even of everythinginterconnectedness will become more important. Customers and patients will require it because with the increasing role of consumer technology in the eHealth ecosystem, proprietary end-to-end solutions will become more and more difficult to defend. Companies can expect to see an increase in interoperability requirements in tender requirements in the EU as clinical institutions will for example expect this for telemedicine solutions. Medical devices manufacturers should work on interoperability standards as the European Commission proposes to give itself ample tool to set standards if it is not happy with what industry develops.
    3. Clinical Decision Support software will and should become more accepted as cost and life and costs saving tool. It is amazing to me that the potential for cost and life saving by leveraging software in medical diagnosis is so widely overlooked. My opinion is that this is because of the incremental nature of deaths and potential cost savings and the disregard of hospitals for deploying quality systems that also monitor diagnostic decisions and identify opportunities and threats. Family of mine that works with quality systems for maintenance and diagnostics for big flying military hardware laugh at the thought of having maintenance mechanics decide by themselves what maintenance is needed and refusing to use software and data to assist wherever possible. This would result in foregoing enormous cost savings and and more consistent precise diagnosis of what maintenance is required. This type of evidence based diagnostics are acceptable in aviation because we don’t like airplanes full of people or loaded with bombs to crash on cities. It is apparently not acceptable in medicine because we don’t mind one person dying at a time in order to keep up the appearance that humans are better in applying diagnostic protocols than machines. And everybody agrees that the medical profession can still learn a lot from aviation in rigorous application of quality systems, see for example here and here. Of course you cannot shoehorn healthcare in aviation procedures one-on-one, but I think nobody proposes that. The EU rules for clinical decision support software are  on the move, with the Commission working on the new version of the standalone software MEDDEV.
    4. The enhancement of humans for non-medical purposes will continue and will take varying degrees of invasiveness. The borderline between devices for remedying a handicap and pure enhancement as well as treatment of a disease will become more and more blurred, as for example intelligence enhancing implantscommunication with comatose patients and prosthetic limbs that make handicapped athletes faster than non-handicapped persons develop. The new MDR proposal responded to this by means of the proposed Annex XV regime, to regulate non-medical devices that are similar to medical devices in terms of characteristics and risk profile under the MDR.
    5. The borderline between medical devices and living materials (e.g. organs) will continue to be blurred further with bioprinting being deployed to print replacement parts of the human body. This will be problematic given the MDR’s new demarcation rules that exclude tissues or cells of human or animal origin or their derivatives. Where the printing consists of a combination of medical device and cells the fun really begins, because the result may be an advanced therapy medicinal product under regulation 1394/2007.
    6. The European Commission is starting to zig-zag under the pressure applied to it because of the proposal for the General Data Protection Regulation that will hit the healthcare (and devices) industry like a ton of bricks (see for example COCIR’s position paper on the subject) and will make processing of health data, genetic data and biometric data a lot more complex. Companies are not happy at all and the Commission is now talking about implementing a risk based approach to regulation, just like the Council is too, which is not necessarily good news for the devices industry because health data, genetic data and biometric data are among the categories of data that are regulated the strictest because of the risks associated. Moreover, I’m not enthusiastic about member states’ plans to make processing of data by public institution, which can lead to unfair competition between companies and clinical institutions when it comes to clinical data. 2013 will also mark the first reading of the regulation, and we will know what the Council, the Parliament and  the Commission are proposing to change in the current draft.

Next year will be another good year for preparing for all the legal and regulatory changes that will hit the medical devices market in the EU. If you are curious as to how the new EU rules proposed for medical devices will play out and have made that a New Year’s resolution, you could check the box on that one by going to this conference in the Netherlands on 29 January. The conference is interesting because of the different model: organized by a publisher and a university it will incorporate more academic debate by having commentators respond to presenters, which is a welcome departure of the usual broadcasting model of presentations – I think. And the quality of the speakers is good, at a fair price. If you use this link to subscribe you get a 5% rebate on the conference fee. Of course I am referring to this conference here also because I am speaking there myself and because my firm contributes, but don’t let that hold you back!