FDA Releases New Guidance to Advance Digital Medical Tech

Digital tool use is growing, and rapidly. To keep up with these changes, the Food and Drug Administration released a Digital Health Innovation Action Plan over the summer. It aimed to redesign medical device regulation to effectively address new tools, while also making way for innovation in the field.

The FDA quickly followed up the plan with several initiatives, including the launch of its Digital Health Software Precertification Pilot Program, which looks to fast-track the development and uses of digital health technologies. The FDA chose nine companies to participate in the program in September, including Fitbit, Samsung and Apple, among others.

Now, to close out the year, the agency has released three policy documents that will shape future health IT oversight and innovation.

“We recognize that our regulations play a crucial role in the efficient development of such technologies. Therefore, our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation,” FDA Commissioner Scott Gottlieb said in a statement. “Moreover, we must always lean in the direction of enhancing access to more information — not restricting information flow — given the ability of reliable information to positively impact daily life.”

Aside from encouraging innovation, the three new guidances — two drafts and one final — also address key provisions of the 21st Century Cures Act that seek to lay out the FDA’s role in digital health — where it is needed and where it is not.

These three new guidances include:

A Clarifying Look at Clinical Decision Support Software

As the pool of health data grows thanks to technologies such as wearables that collect data on everyday activities, the need to sift through data and use it to create actionable insights is rising. Backed by machine learning, clinical decision support (CDS) software aggregates and digests healthcare data to help inform or support clinician decisions on treatment options, diagnostic tests and more.

“This type of technology has the potential to enable providers and patients to fully leverage digital tools to improve decision-making,” Gottlieb said. “We want to encourage developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating old and new medical maladies.”

The FDA hopes to do this by releasing a new draft guidance that will clarify which types of CDS will not qualify as medical devices, and therefore not fall under FDA regulation.

Essentially, the guidance outlines that CDS or similar patient decision support (PDS) software that allow the clinician to “independently review the basis for the recommendations” will not fall under FDA guidance. Software that analyzes or processes “images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram” and uses these analyses to make treatment recommendations will fall under FDA oversight.

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Cyber security a growing concern for Canadians

Canadians are more concerned about cyber security than they were in 2016.

According to the Canadian Internet Registration Authority (CIRA)’s latest Internet Factbook, 75 per cent of Canadians are worried about the threat of cyber attacks against organizations they know, a 13 per cent increase from 2016.

They’re also less likely to make online purchases from a business after a cyber attack: Nearly 45 per cent of Canadians surveyed said they would probably stop buying items online from a business following a major cyber attack, which happens nine times more often per capita in Canada than in the U.S.

“The first step to building a better online Canada is understanding the experiences, perceptions and needs of Canadian internet users,” Byron Holland, CIRA president and CEO, said in a press release.

Jacques Latour, CIRA’s chief technology officer, echoed Holland’s statement, while calling for investment in Canada’s Internet infrastructure, which he said would contribute to a healthier online environment in Canada.

“Over three quarters of Canadians are concerned about their personal information on the Internet if it is stored or routed through the U.S,” Latour said. “Investing in Canadian Internet infrastructure, which includes local Internet exchange points that help Canadian data stay within our borders, should be a priority for governments, businesses and Canadian Internet service providers.”

But it’s not just large companies that have to contend with cyber attacks. The Canadian Chamber of Commerce’s Cyber Security in Canada report says 71 per cent of all breaches impact small businesses.

 

 

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3D Printing: FDA Finalizes Guidance for Medical Devices

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The US Food and Drug Administration (FDA) on Monday finalized guidance on medical device additive manufacturing, also known as 3D printing.

The guidance finalizes the draft version from May 2016 and largely keeps intact the recommendations and considerations laid out in the draft.

FDA Commissioner Scott Gottlieb said Monday that the guidance “will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and [ensures] our regulatory approach is properly tailored to the unique opportunities and challenges posed by this new technology.”

Gottlieb also said that FDA has now reviewed more than 100 3D printed medical device applications, including knee replacements and implants used for facial reconstruction, up from the 85 reviewed at the time the draft was released.

FDA describes the guidance as a “leap-frog” guidance in that it is meant to provide manufacturers about its initial thinking on manufacturing 3D-printed devices and how to characterize and validate such devices. The final guidance also emphasizes that the recommendations made will not be applicable to all 3D-printed devices due to the wide array of available additive manufacturing technologies and materials.

Some changes in the final guidance include new considerations for handling complex design files and cybersecurity considerations for patient-matched devices.

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How the Future of Finance Gives You Total Control

In the world of commerce, internet is king as it never sleeps and continues to take transactions long after you and I have laid to rest for the night. With the evolution of finance and online transactions the internet world has taken large steps to make it easier for the consumer and investor to feel more safe and secure with the funds which are being processed.

Remember when Paypal came on the scene? “E-commerce”? It was still like a toddler – wobbling across the room and making the grown-ups feel just a little nervous. Now it’s just commerce. People latched onto this new way of transacting and now it is one of the biggest modes of payment.

Future

Like Paypal, cryptocurrency has big potential. In 2009, Bitcoin launched onto this transactional scene and today, hot on its heels, enters Zen Protocol, a blockchain which is built for finance and completely erases the need for bankers and brokers.

What does this mean for you as a consumer or financial investor, and how does Zen Protocol make a good product even greater? I’m glad you asked. Let me give you the three tips why ZP is one of the hottest reasons you should get involved.

#1 – Safety and Security are Key

When you press the “BUY” button on your favorite clothing line do you pause and hope your financial information won’t be stolen?

I would wager the answer to that question is a “No”. You trust them. You’ve purchased from them before or know someone who has. Besides, their site has that little “s” at the beginning of the URL.

All joking aside, when it comes to cryptocurrency, security and safety is no joke with these guys. You may or may not have heard, but a few weeks ago over $150 million were permanently frozen on the Ethereum blockchain by what seems to have been a mistake. The cause: an Ethereum contract called “Parity multisig”, used by numerous individuals and organizations to store their funds, contained a simple bug.

Believe it or not, this was the second critical bug for this contract. Back in May, when the first flaw was discovered, some “white hat” hackers saved most of the tokens and returned them to their owners. Not this time.

Zen Protocol takes steps to solve the security and safety issue by making it easy to ensure the code actually works for you. It works with a language designed to prove what contracts do – a method called “formal verification”. It also makes simple transactions – like multisig – easy to do, without using special contracts.

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Intensifying Cybersecurity Fears Could Fuel Blackberry Rebound

Sometimes there’s a temptation to think that cyberattacks are an unfortunate consequence of our ever-increasing interconnected digital world, which is underscored by the fact that most Americans walk around with a personal computer in their pocket. Cyberattacks, however, are nothing new.

In 1999, the so-called Melissa virus infected Microsoft Word documents and wreaked havoc on business and personal computers powered by Windows worldwide. It caused an estimated $80 million in damage and was the impetus behind the sales boom in anti-virus software, which has gained near universal acceptance since. Shortly after that, in 2000, a hacker dubbed Mafiaboy unleashed a series of distributed-denial-of-services (DDoS) attacks on a string of consumer sites, including Amazon, eBay, E*TRADE and Yahoo!, at the time the no. 1 search engine in the world. The blitz resulted in over $1 billion in damage.

Still, there’s no question that cybersecurity concerns have become more acute more recently. In all, cybersecurity lapses cost the global economy $450 billion last year and will exceed $2 trillion by 2021, according to estimates. That suggests that companies getting ensnarled in a hacking incident is as much an inevitability as it is a risk. The fallout will paralyze some businesses and entail massive PR problems (It took Target years to overcome the breach that took place during the holiday shopping season a few years ago), while for others the implications will be far worse.

Not surprisingly, then, the market for cybersecurity goods and services is expected to expand rapidly in the years ahead. According to the research firm Cybersecurity Ventures, global spending in this area will grow, year-over-year, by 12% to 15% until 2021, when it’s expected to exceed $1 trillion. This would seem to spell good news for cybersecurity firms such as FireEye, Symantec and Palo Alto Networks.

A more under-the-radar beneficiary, though, could be Blackberry. The company’s past troubles are well documented. It’s essentially the Blockbuster Video of smartphones, once controlling more than 50% of the market, only to see their dominant position implode once Apple and Alphabet developed superior operating systems. Blackberry has since shunned its hardware business entirely, announcing last year that it will focus on enterprise software and the emerging internet of things (IoT) industry.

As part of this evolution, the company last month launched a cybersecurity consulting division, the culmination of a fresh round of strategic acquisitions that beefed up its expertise in the area. In many ways, this is a natural evolution for Blackberry, which has long been a leader in encryption services. For years, it was the preferred handset provider for US government officials who trafficked sensitive information, including White House staff, members of Congress and the intelligence community, thanks, in part, for its reputation for successfully securing devices.

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60 Cybersecurity Predictions For 2018

Like death and taxes, there are only two safe predictions about cybersecurity in 2018: There will be more spectacular data breaches and the EU General Data Protection Regulation (GDPR) will go into effect on May 25. But as the continuing digital transformation of our lives entails the ongoing digital transformation of crime, vandalism and warfare, 2018 could also bring a lot of new takes on old vulnerabilities, some completely new types of cyberattacks, and successful new defenses.

The following list of 60 predictions starts with three general observations and moves to a wide range of cybersecurity topics: Attacks on the US government and critical infrastructure, determining authenticity in the age of fake news, consumer privacy and the GDPR, the Internet of Things (IoT), Artificial Intelligence (AI) as a new tool in the hands of both attackers and defenders, cryptocurrencies and biometrics, the deployment of enterprise IT and cybersecurity, and the persistent cybersecurity skills shortage.

IoT vulnerabilities will get more critical and more dangerous. Despite this, there will be no real changes in US law to regulate these devices. This isn’t a very risky prediction; Congress is currently incapable of passing even uncontroversial laws, and any IoT regulation faces powerful industry lobbies that are fundamentally opposed to government involvement. More interesting is what’s happening in Europe. GDPR takes effect next year, and European regulato rs will begin to enforce it. The regulation has provisions on security as well as privacy, but it remains to be seen how they will be enforced. If Europe starts enforcing Internet security regulations with penalties that make a difference, we might start seeing IoT security improve. If not, the risks will continue to increase—Bruce Schneier, Schneier on Security

Sophisticated adversaries will leverage the granular metadata stolen from breaches like Equifax, OPM, and Anthem, in precision targeted attacks that rely on demographic and psychographic Big Data algorithms powered by machine-learning and artificial intelligence. Attackers will deploy armies of bots to propagate the false narratives used to weaponize malicious fake news, inflate partisan debates, and undermine democratic institutions; meanwhile, they will launch multi-vector DDoS, ransomware, and malware campaigns to impede critical infrastructure cybersecurity and national security. The demographic and psychographic metadata will enable advanced spear-phishing operations against privileged critical infrastructure executives and pervasive Influence Operations against populations—James Scott, Senior Fellow, Institute for Critical Infrastructure Technology

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Statement from FDA Commissioner Scott Gottlieb, M.D.

As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we’re focused on taking actions that reduce the scope of new addiction by decreasing unnecessary exposure to opioids. At the same time, we also must take steps to help those with acute and chronic pain who need access to medicines, including opioids, get access to improved alternatives. Until we’re able to find new non-opioid forms of pain management for those who need treatment for pain, it’s critical that we also continue to promote the development of opioids that are harder to manipulate and abuse, and take steps to encourage their use over opioids that don’t offer any form of abuse deterrence.

Opioids with abuse-deterrent formulations (ADFs) are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding. To date, the U.S. Food and Drug Administration has approved 10 opioid drugs with these properties. But their uptake has been slow among doctors who are treating patients in pain. The reason for their more limited use is likely multifold. We know there can be a learning curve that comes with new technologies. Some prescribers may not be aware of the existence of these drugs, or may be uncertain of when to prescribe the abuse-deterrent versions. But we also know a significant barrier to use can be price. Because these new formulations are currently only available as brand-name products, they’re inherently more expensive than the numerous non-abuse deterrent formulations that are also available in generic formulations.

Transitioning from the current market, dominated by conventional opioids, to one in which most opioids have abuse-deterrent properties, holds significant promise for a meaningful public health benefit. But to transition this market more quickly to the ADFs, and consider permanently withdrawing the older formulations that lack abuse-deterrent features in the event these products were judged to be less safe ‒ there are a number of factors we must consider. One of the factors that the FDA would consider relates to generic access. We must have the potential to improve access to the newer formulations, for appropriately selected and monitored patients, through the introduction of generic competitors.

In order to support this transition and encourage advancements in this area, today the FDA issued a final guidance to assist industry in their development of generic versions of approved ADF opioids. This guidance includes new recommendations about the type of studies companies should conduct to demonstrate that the generic drug is no less abuse-deterrent than its brand-name counterpart. We’re also taking additional steps beyond the new guidance to help developers of generic ADFs navigate the regulatory path to market as quickly as possible and make the review process more efficient and predictable. For example, we’re developing appropriate, improved testing methodologies for evaluating complex features like abuse deterrence for both brand name (innovator) and generic opioid drug products. In addition, we’re also taking a flexible, adaptive approach to the evaluation and labeling of ADF opioids.

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