Regulation

Brexit and the Falsified Medicines Directive

In order to help patients avoid being exposed to falsified medicines, the European Commission developed a series of measures to support patients in identifying licenced suppliers of pharmaceutical medicines, and suppliers to identify whether an end-user pack of medicines was genuine. The measures outlined in the Falsified Medicines Directive (2011/62/EU) have been applied across the European Union (EU), with […]

‘IT’ gets man wrongly arrested for prescription fraud

A man presented a legitimate prescription (signed by a out-of-hours service doctor) at a community pharmacy in November last year. Pharmacy contacted the out-of-hours service then called the police.
The board papers show the pharmacy contacted IC24 who “confirmed no record of the patient being seen by an IC24 doctor”.

However, subsequently IC24 changed its view and said that the prescription was […]

February 2nd, 2017|Regulation, Value|0 Comments|
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    What is the public getting for data deals? Public Lecture 22 March, 2017

What is the public getting for data deals? Public Lecture 22 March, 2017

Data kingdoms and keys: The case of Google and the NHS

Dr Julia Powles
22 March, 4.00pm, School of Law, LG.06

For this year’s annual lecture on law and emerging technologies, we take on the valiant promises of computation and artificial intelligence – and the data deals necessary to power them. Across every field, from health and energy, to law and finance, […]

February 1st, 2017|Big Data, Regulation|0 Comments|

First patient facing app to get GP system approval

iPatient expects to get approval to integrate with a GP primary system sometime soon. The system enables patients to view their health records and test results, book appointments, use secure messaging, and request repeat prescriptions.

It has taken years of development to get to this point, with pilots in five GP practices using the Emis Health primary system.

Full article here:

August 8th, 2016|Regulation|0 Comments|
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    Hub and Spoke Dispensing: Privacy and Sociotechnical Rigidity

Hub and Spoke Dispensing: Privacy and Sociotechnical Rigidity

In a previous post, we noted how a hub and spoke model for community pharmacy had been promoted on the basis of a limited safety case. The hub and spoke model that was described was one in which items would be assembled at a hub site that would serve a number of dispensing sites, such as community pharmacies. Although […]

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    Hub and Spoke Dispensing: Safety and Sociotechnical Pliability

Hub and Spoke Dispensing: Safety and Sociotechnical Pliability

Over the course of the last year, the Department of Health has looked at the use of hub and spoke dispensing systems for community pharmacy in England, a technology which some view as an inevitable extension of electronic prescription transmission in primary care. In a hub and spoke system, medicines required for a primary care prescription are put together […]

Google and Patient Data

Further to our blog post last week, Google is now being investigated by the data protection watchdog: the Information Commissioner’s Office (ICO) over it’s data deal between the Royal Free Hospital Trust and DeepMind.

The investigation results from ‘at least’ one complaint received over the anonymising of data. While the Hospital Trust declare that all data is anonymised in transit and […]

Accelerating access to new drugs in Japan

Writing in Nature Reviews Drug Discovery, Yasuhiro Fujiwara outlines developments in Japan to reduce the time required for new therapeutic drugs to gain marketing authorisation.

Fujiwara notes that Japan historically has taken longer than the United States and the European Union to give marketing approval for therapeutic drugs. Over the course of the last 20 years approval times have been […]

Testing & Mental Health Apps

In a recent article, Nature raises concerns that ‘the technology is moving a lot faster than the science’ and many of the apps designed and marketed to help with mental health care are simply not tested. This leaves customer-patients vulnerable to apps which, at best, don’t work and could make their condition worse.

 

Of course, these apps do many things: some […]

April 25th, 2016|Regulation|0 Comments|

FTC Guidance – Marketing Your Mobile App: Get It Right from the Start

In the news this week:
The Federal Trade Commission, in partnership with the Office of National Coordinator for Health IT, the HHS Office for Civil Rights and the U.S. Food and Drug Administration, released an online tool this past week to give mobile app developers legal guidance for the development of their health products.
The FDA has limited regulatory oversight since […]

April 18th, 2016|Regulation|0 Comments|