The U.S. Food and Drug Administration has released final guidance dealing with medical applications running on mobile devices, including consumer smartphones and tablets. Under the new guidance, the FDA indicates that it intends to treat some apps with the same scrutiny which is applies to traditional medical devices.
This guidance has profound (although not entirely unexpected) impact on app developers exploring and exploiting the use of consumer electronic devices to empower people in medical and healthcare related ares. Under the new guidance, developers must look to the functionality of their software, and where appropriate, submit it to the FDA for review and approval. Typically the line of demarcation depends on whether the application interfaces with a regulated medical device, such as blood-pressure monitoring device, or if the app turns the mobile device into a device for assessing the health of an individual. Unfortunately, these lines are somewhat indistinct thus leaving app developers with open questions about whether apps that may skirt these lines are subject to FDA review or not.
This is an area where the law and regulations will continue to evolve over time. In the meantime, app developers who are venturing into products applications which could potentially fall within the jurisdiction of the FDA need to carefully consider their offering and implications of potential regulation by the FDA.
It appears that a police officer in Gwinnett County, Georgia (a suburban county to the Northeast of Atlanta, for the uninitiated) has issues nearly 800 tickets for texting and driving this year. According to the officer, the most common place where he catches offenders in the act is at traffic lights.
Georgia law prohibits not only texting, but any use of internet or web-based data, including web-based GPS navigation, while behind the wheel of a car, unless that car is parked and safely off the roadway.
The Verge has put out an interesting piece on the recent changes to Rule 506 of “Reg. D”, the section of federal securities regulations dealing with “private placements” of investment, such a angel investment and seed-round funding. Generally the changes, implemented as part of the JOBS Act, are intended to loosen some of the prohibitions on advertising investment opportunities in companies seeking private investment. There still, however, remain a lot of stings attached not only to the process of seeking such investment, but also in the process of actually receiving that investment (or determining if you can receive a particular investment). This is still an enormously complicated subject, fraught with potential peril for both potential investors and for the companies seeking outside investment.
The good news is, there are actual efforts underway to rationalize at least some of the existing restrictions on these types of “private placement” investments, and it it likely that further easing of restrictions will continue to come about. There is unlikely to ever be a “free and open market” for private placement investments, due to overriding concerns regarding fraud. That having been said, any steps creating a more rational marketplace for private investment is potentially a good thing for our entrepreneurial economy.
Within just days of the release of the new iPhone 5s, it appreas that hackers have already found a way to break Apples new fingerprint-based biometric security feature, TouchID.
Apple indicates that it is working on fixes to this apparent vulnerability already, but in the meantime, it just goes to show that reliance on new security standards or features must be done cautiously until that system is thoroughly vetted.
RSA Security, a noted data security tool maker, is advising its customers to stop making use of its BSAFE toolkit and Data Protection Manager, as it apparently includes a back-door-type vulnerability in the underlying cryptographic standard, which was engineered with input from the National Security Agency (“NSA”).
In particular, the Dual EC_DRBG pseudo random number generation routines used in these tools were deliberately compromised and/or crippled, thus undermining the security of most, if not all, of the cyptography systems which make use of it.
These vulnerabilities potentially extend to such products the McAfee Firewall Enterprise Control Center and other products using BSAFE or other systems relying upon Dual EC_DRBG.
The concern arising from this intentionally introduced vulnerability is that, not only does it make any data protected using this standard potentially open to penetration by governmental agencies, but that it undermines the overall reliability of the encryption, thus also throwing encryption based on this technology open to hacking by either foreign governments or criminal hackers.
Wired has a interesting opinion piece on iOS 7’s potential to create a new boom in app development. While the article does speak primarily to some of the advances in iOS 7 and the new iPhones, it actually speaks in a broader sense to the increasing trend away from traditional keyboard computing (whether desktop or laptop) to a much more mobile one and how that has and is affecting the user-interfaces that we utilize to interact with those devices.
Interesting article. While I certainly think it is good to teach children about intellectual property, what it is, and what the law has to say about it, I, personally, am not very comfortable with the idea of particular industries writing pro-industry curricula for our schools.
This begs the question (without answering it), of “where should the line be drawn in public / private partnerships, particularly when it comes to childhood education?”