In a move of solidarity, Google supports Apple in its fight against the US government to provide a “back door” into the popular iPhone…a move that would allow the government to hack all of Apple’s customers.
Google CEO Sundar Pichai just weighed in on Apple’s battle with the FBI, which has ordered Apple to help it unlock the phone of one of the shooters who killed 14 people in San Bernardino, California, last year in an apparent terrorist act.In a series of tweets, Pichai wrote that although Google gives “law enforcement access to data based on valid legal orders,” that is “wholly different than requiring companies to enable hacking of customer devices and data,” which could set a “troubling precedent.”
I would love this. “What time is it on Earth?” #UTC https://www.washingtonpost.com/news/worldviews/wp/2016/02/12/the-radical-plan-to-destroy-time-zones-2/?tid=sm_fb
As a business traveler, this is troubling news:
Due to the government’s knee-jerk reaction, the cost of travel will be rising sharply. Now, I hate getting trapped on the plane too, but the cost of these fine (and the costs associated with avoiding them) *will* be passed on to consumers….as will difficulty in getting where we’re going. Sounds like a great idea, doesn’t it?
As all of the discussion on Healthcare reform comes to a head, I think it warrants some comments from me regarding “The Greed of Pharma”. Let me start by saying that Pharma is a for-profit business like any other.
I think it is important to note that neither pharma (nor the insurance industry for that matter) has particularly high profitability (ROE %’s). The following industries have a higher ROE % (Return on Equity rating) than Pharma (21 of them, and in the order listed). Cigarettes has nearly triple Pharma’s profitibility (and the US Gov is a de facto share holder); Aerospace has double. So why would Pharma be expected to foot the healthcare bill (and squeal like a pig -to paraphrase Congressman Marion Berry of Arkansas) when there are so many other more deserving candidates?
Aerospace/Defense – Major Diversified
Information & Delivery Services
Diversified Computer Systems
Beverages – Wineries & Distillers
Processed & Packaged Goods
Auto Parts Stores
Education & Training Services
Industrial Metals & Minerals
I’ve submitted this abstract to the SQA for their annual meeting in April and am really hoping it is accepted. A very similar one that I posted last year was not….but this year, it seems that this sort of stuff is on their “hot topic” list. Fingers crossed.
The Impact of Electronic Systems, eHRs, and eData on Clinical Research
Although the use of electronic data in the pharmaceutical industry is by no means a new phenomenon, its impact has evolved over time. Technology has revolutionized our lives in many ways; in the way we access information, in our entertainment, in the way we do business, and in the way we interact. This technological revolution has had very pronounced impacts on the GxP industries: eRecords, eData, eSignatures, Data Processing, Data Mining and the Regulatory Standards associated with them.
These impacts have been most apparent in the cGMP and GLP areas and there is a fair level of comfort with eData and Validation in those areas. Increasingly however, the impact of eData and the need for controls around its use can be seen in the GCP area. Due to its large reliance on external sources of data, Clinical Research has some unique challenges. This session will cover:
I. Technology in Pharma and Validation Overview: a discussion of these concepts (which are widely felt to be cGMP artifacts) and relating them to the GCP area through analogies.
II. Centralized GCP Technology: The use of centralized eData and eSystems, primarily on the “sponsor side” has some unique challenges due to very short timelines and the external nature of clinical data inputs. Also the challenges of study-specific validation activities will be addressed.
III. De-Centralized GCP Technology – “Technology at the Clinic”: The advent of electronic Health Records (eHRs) has had a profound impact on Clinical Research and the way in which source data is handled, however the adoption of eHRs has been uneven, piecemeal, and largely independent of any research concerns . Resultantly, source data at clinical sites varies widely in format, from purely paper systems through purely electronic integrated source systems. However, a large and growing number of sites use a hybrid paper/electronic model with various sources of data, scans of source destroyed by hospital systems, paper notes, dictated notes, email notifications, and central sponsor data collection systems. Some ideas on how to address various hybrid source data scenarios will be presented.
Level: Basic Validation, Intermediate Clinical
Key Words: GCP, Electronic Data, Hybrid Source, Validation
I’ve gotten some questions of late that have had me thinking about the core of what I do; fundamental questions as to what it is and why. This is a good thing and I feel that now is a good time to till this fertile soil and see what can be learned (or remembered).
Over the next few weeks, I plan to explore these ideas in a series of posts. I’m planning on submitting an abstract or two to the SQA conference and this will be a good stepping-off point to get that effort underway. I plan to present on a subfield in which I am working very heavily in my current role; Clinical System Validation. That is, Computer System Validation for the Clinical (GCP) arena within the greater pharma landscape (pharma, medical devices, and related industries).
In any case, its been too long since I’ve added some really good content here. Keep your fingers crossed that I’ll be able to put up something useful, interesting, or both.