Julian Hitchcock, ably assisted by Zac Fargher, has kindly agreed to spend an evening updating people on the regulation of medical and in vitro devices at a joint DHACA/Heath Technology Forum London meeting on Wednesday 17th July.
This comes at a time of huge uncertainty so Julian and Zac’s advice will be especially important for members: in addition to Brexit, the Notified Body capacity crisis is imperiling the implementation dates of both the MDR in 2020, and the IVDR after that.
Anyone following this editor’s recommendations will already be aware of Julian’s presentational clarity and depth, and his very humourous style.
Booking is here. Please try to arrive at 6.15 pm on 17th July so we can get started promptly at 6.30 pm. Julian and Zac will speak until 8pm, after which there will be time for networking drinks, kindly sponsored by Bristows, who are also generously hosting us for the evening.
Do come and join us!
Confused on how a CCG (clinical commissioning group) is funded? Mystified about the relationship between local authorities and the NHS? Updated last month, The King’s Fund’s handy organograms (US=org chart) explain the formal organization of the NHS, how it is funded by Parliament, and the relationships between entities. The slides are downloadable. There are also two six-minute videos that tackle how NHS and NHS England work. See this page also for links to content on local service design, governance, and regulation, plus NHS finances. How is the NHS structured?
But it may break them…well, give them a fracture. Or a good hard marketing lesson. Specialty pharma Duchesnay thought it had hit the jackpot with negotiating a promotional spokeswoman endorsement from pregnant celebrity Kim Kardashian of its morning sickness drug Diclegis. The Kardashian Marketing Machine cranked up. Kim (and mom Kris Jenner) took to Instagram, Facebook and Twitter in late July with (scripted) singing of Diclegis’ praises to their tens of millions of followers. The Instagram posts linked to an ‘important safety page’ a/k/a The Disclaimers. That wasn’t near enough for the Federal Drug Administration (FDA) which governs the acceptable marketing of all drugs in the US. On August 7th a tartly worded letter arrived at Duchesnay’s Pennsylvania HQ cited multiple violations of marketing regulations, notably risk information, and told Duchesnay to cease these communications immediately or withdraw the drug, which would be highly unlikely as it is successful. They also were require to provide “corrective messages” to the “violative materials”.
* Duchesnay reaped a bounty of free media (see below), on top of the (undoubtedly expensive) Kardashian endorsement. Yes, they did pay the cost of a FDA nastygram and a legal response, and the warning will live on in their file. However, a lot of target-age women now know Diclegis and others know about the relatively obscure Duchesnay.
* This was a calculated marketing risk that tested the boundaries of social media and celebrity endorsement. (more…)
Medical apps may not be strangers to doctors’ offices anymore but they also realize that apps are difficult to recommend responsibly to patients or even to find, because there is no real guidance or validation. This current article in JAMA online confirms the perception and the need for care integration that both Editors Charles especially and Donna have pointed out lo these many years. However this Editor is quite disillusioned at the attempts to date to ‘curate’ apps with the Happtique failure and the relatively low profile to date of IMS Health’s AppScript and professional review site iMedical Apps and the stated intentions of SocialWellth which purchased Happtique. The reality is that the numbers are against it–IMS Health in their study estimated 40,000 medical apps–in 2013. For apps that want to take the high road, it’s economically difficult, but could be rewarding in the long term. The WellDoc BlueStar diabetes tracking and management support app did with FDA clearance and prescription-only use, but few so far can see a revenue model there. Also MedCityNews.
Intended use determines degree of health app regulation–and also how you communicate your attributes and performance claims. Bradley Merrill Thompson, who performs an invaluable service by advising our field on regulation, compliance and interacting with FDA, demonstrates how a developer can determine where the intended use of an app might fall (more…)
PWC Health Research Institute has released a Spotlight Brief on the US telehealth (read telemedicine for telehealth) regulation which states that recent regulatory action may be the catalyst to spur the fledgeling telehealth market.
Expansions in Medicare reimbursements, Government telehealth grants amounting to several million dollars and legislative action in many States are all seen as supporting new entrants as well as traditional players and growing the US telehealth market that PWC says is estimated as high as $10 billion.
Benefit to consumers is of course lower costs and easier access. Challenges mentioned are licensing, reimbursement, privacy and security. Read the full report here.
Just tripped over this interesting item by Dana Pirvu on the Epstein Becker website favourably contrasting the EU approach to regulating telehealth with the US approach: well written and concise…and nice to see that Europe is ahead in this area. It was posted in April but still seems very relevant.