Many healthcare providers are turning to consumer mobile devices to collect and deliver telemonitoring healthcare data, and lack of regulation is putting CIOs in an awkward spot.
The fact that consumer smartphones and tablets are cheaper than specific medical equipment opens a new market for their manufacturers. Just last summer, Samsung agreed to modify and create a custom version of their Galaxy SII smartphone for Preventice -- a developer of mobile health solutions and remote monitoring systems -- disabling downloads, which might interfere with the cellular connection, and enabling the phone to be used for their BodyGuardian telemonitoring application.
Applications such as BodyGuardian collect information from different sensors implanted on the patient, and then transmit those readings to the cloud using a wireless connection. Physicians are then able to login and see data.
While this is good news for healthcare providers, insurers, and patients, it becomes an issue when the privacy of electronic health records is involved. Medical devices are required to be FDA approved, and need to comply with the privacy regulations of the Health Insurance Portability and Accountability Act (HIPAA), but smartphone apps don’t currently have the same restrictions.
Storing and monitoring data in the cloud is a good way to manage massive amounts of information and ensure wireless access by physicians, but it raises many questions about who owns the data and how secure it is.
Some patient and privacy advocates are starting to complain about the possibility that telemonitoring providers could be selling their data to third parties, mostly to marketing firms, drug companies, and insurers. For some patients, the most disturbing fact is that they don’t know where, how, and for what purposes their healthcare monitoring data is stored and processed -- and they can’t get access to it.
In order to see a glimpse of the data their bodies are sending over the cloud, they need an appointment with their physician.
In the United Kingdom, the National Health Service (NHS) has promised to allow patients full access to their healthcare records, mostly electronic ones, by 2015, after they implement the necessary software and infrastructure for it. The European Union, through their Data Protection directives and regulations, legislates that every EU citizen has the right to access, modify, and cancel any data about themselves that is not legally required, including the “right to be forgotten.”
But American healthcare providers don't need to inform their users about the data they keep, control, and analyze, and are finding new ways to monetize that data.
The FDA has been looking at this issue and plans to make a review of mobile devices and apps used in conjunction with monitoring devices to see if the information collected and its processing complies with patients’ privacy rights. Eventually, it many force all app manufacturers to seek the agency’s approval before marketing their products to healthcare professionals.
Companies such as Preventice are seeking FDA clearance for products such as BodyGuardian, but as stated in the FDA letter of “approval,” the devices “do not require approval of a premarket approval application (PMA).”
It's interesting to note that Preventice sought approval for the monitoring device, not for the transmission unit. Even if the FDA required additional testing of the monitoring devices, there is no assurance that the smartphone, another “transmission device,” or the cloud service, wouldn't be compromised.
Without a clear set of rules requiring all companies collecting healthcare information to clearly inform the patients where the information is stored, how it can be processed, and when it can be sent to third parties, CIOs are placed in an awkward position.
CIOs would be foolish to avoid these apps, which most definitely provide a valuable service for doctors, and often at a fraction of the cost of medically-approved devices. But if you select a device that is eventually ruled to be in violation of future privacy regulations, the expense could be considerable. While not always possible, smart CIOs might want to be extra careful and assume all privacy regulations in place for medical devices are already in place for mobile apps and cloud usage.
When that isn't possible, at the very least, it would be wise to pick a partner that seems to have patient privacy in mind, rather than ones who are definitely and openly selling patient information.
At the very least, CIOs should be as explicit as possible with partners over precisely what is happening with all data they don't have full control over. Knowing now will save you a lot of trouble as the situation evolves.
Your Wireless Medical Device is Mining Your Health Data
Flexibility and IT Made Zara the Biggest Fashion Retailer
Manufacturers and retailers looking to model "just-in-time" manufacturing and logistics could do much worse than look at Zara.
Most people outside of Spain knew little or nothing about Zara, the now hugely successful fashion retailer, until about a decade ago. Owned by Spanish company Inditex, 37-year-old Zara overtook Gap as the biggest apparel retailer in the world in 2008. Now it has 5,887 retail stores -- 360 opened just last year -- and 116,110 employees in 86 countries.
There are several factors behind Inditex's success in the highly competitive fashion market:
Vertical integration: Inditex wants to keep store inventory to a minimum, and keep a fast turnaround of new products. This encourages customers to buy the product as soon as they see it in a store because the same product might not be there the next time, and Inditex does not always send stores the same product twice.
Customer feedback and fast response: The IT infrastructure of the company and fast logistics allows the company to deliver a sold-out product to a store in India in less than 48 hours.
Customers are encouraged by the sales staff to comment on products and give opinions about why they like or dislike any particular garment. Store managers collect this information daily and send it to headquarters, where it is evaluated by marketers and designers. Keeping the manufacturing of designs close to home enables a quick turnaround, from design to store in about three weeks.
Proximity to factories: Inditex does manufacture some clothing in Asia, but not to save cost. It is to save time in supplying the Asian market and to keep its own factories in Europe and North Africa free to respond quickly to customer demands.
Location: Inditex's investment in real estate is legendary; they own premium commercial space in many cities. Recently, the group purchased the building housing the newly-opened Apple store in Barcelona, considered to be the most expensive real estate in the city. They have opened Zara, Massimo Dutti, and other store brands in the vicinity of luxury neighbors, such as Gucci, Prada, and Cartier. According to The New York Times last November, Inditex paid $324 million last year to buy space at 666 Fifth Avenue, the most expensive retail space ever sold in Manhattan.
Interestingly, Zara retains part of its flexibility by choosing its markets carefully. The "just-in-time" approach leads them to largely ignore the lucrative American market. You can find Zara stores in cities such as Boston, New York, Los Angeles. and Chicago, but you can't find them in most malls. One reason is the larger clothing sizes necessary for the American market. "Zara to me is a European store for European style; it's very fashion forward. And what is the problem in America? They don't fit in the clothes. So why do it? Having to make larger sizes makes production so much more complex,” said Jesus Echevarria, in the New York Times story.
Zara's strategy in America may seem limiting in one aspect, but it is actually indicative of consistent decisions to align manufacturing and retail decisions to keep supply chains short, communication intimate, and provide fast response to the customer and to retail outlets.
CIOs looking to achieve similar results need to work with the CMO to align customer communications and marketing while working with the CFO, COO, and CEO to align the manufacturing strategy with the strategy as a whole. It is Zara's close alignment and focus on short lines of supply and communication that make it so quick and flexible. Every CIO can make changes like these "just in time" to save their company.
Is The Wikipedia Effect Plagiarism?
Most analysts agree that the $6 billion textbook business in the US is ripe for a digital makeover. But authors, publishers, and retailers are facing a bigger threat to their long-established business -- free electronic textbooks.
Basically, it’s the Wikipedia effect. There are several “free” online resources with all the material necessary to compile the same, if not more, information found in any conventional textbook.
So, how do you go from Wikipedia and other free content sites to a full e-book that matches the $200 textbook used in your Calculus class? Boundless Learning, a Boston company that has been giving away free electronic textbooks for college students, has the answer.
Boundless founder Ariel Diaz found his new business idea when trying to take a crash course on “Quaternions” for a consulting project. Instead of buying a book on the subject, he used a Wikipedia article, and found it extremely detailed and accurate. The difference with Boundless is that it uses the content available online to create a free alternative to existing textbooks, pulling freely-available articles from online sites to match the information (not the words) found on the original.
Teachers are also joining the revolution. Many university professors are beginning to give away free electronic versions of their textbook for individual classes. Instead of trying to make more money selling the book, they want to have more students attending the class. Their classes become popular, and students are happy to not spend more money on textbooks.
It's tempting for schools to embrace this technology. Colleges and K-12 schools are struggling worldwide to get funding, and students are complaining about increasing tuition fees. Saving money on textbooks could ease the pain and help more students afford college. K-12 administrators, especially CIOs charged with bringing new technology and course materials into the classroom, would love to save money and bring in new technology at the same time.
College CIOs should look at the possibilities of new editing platforms, and facilitate the digital transformation of course content for instructors and students.
But there may be an important catch. Publishers (Pearson Education, Inc.; Cengage Learning, Inc.; Bedford, Freeman & Worth Publishing Group, LLC, and D/B/A Macmillan Higher Education), are now suing Boundless, claiming that Boundless “generates these 'replacement textbooks' by hiring individuals to copy and paraphrase from Plaintiffs’ textbooks." Boundless refutes the charges, saying it uses sophisticated algorithms and human editors to compile the books from copyright-free online sources.
With legal issues pending, it might not be the best time to invest in bringing these e-books into the classroom. And some would certainly question the potential value of a textbook made by a computer, edited on the cheap, and given for free. But, ultimately, something has to be done.
As Dr. Mark J. Perry, Professor of Economics at the University of Michigan says, “The cost of college textbooks has been rising at almost twice the rate of general CPI inflation for at least the last thirty years.” He claims that textbook publishers operate a “cartel-style” model.
