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The FDA hopes to do this by releasing a new draft guidance that will clarify which types of CDS will not qualify as medical devices, and therefore not fall under FDA regulation.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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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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Trump administration pulls back curtain on secretive cybersecurity process

The White House on Wednesday made public for the first time the rules by which the government decides to disclose or keep secret software flaws that can be turned into cyberweapons — whether by U.S. agencies hacking for foreign intelligence, money-hungry criminals or foreign spies seeking to penetrate American computers.

The move to publish an un­classified charter responds to years of criticism that the process was unnecessarily opaque, fueling suspicion that it cloaked a stockpile of software flaws that the National Security Agency was hoarding to go after foreign targets but that put Americans’ cyber­security at risk.

“This is a really big improvement and an outstanding process,” said White House cybersecurity coordinator Rob Joyce, who spoke at an Aspen Institute event and issued a blog post on the charter.

By making it public, he said, “we hope to demonstrate to the American people that the federal government is carefully weighing the risks and benefits” of disclosure vs. retention.

The rules are part of the “Vulnerabilities Equities Process,” which the Obama administration revamped in 2014 as a multi­agency forum to debate whether and when to inform companies such as Microsoft and Juniper that the government has discovered or bought a software flaw that, if weaponized, could affect the security of their product.

The Trump administration has mostly not altered the rules under which the government reaches a decision but is disclosing its process. Under the VEP, an “equities review board” of at least a dozen national security and civilian agencies will meet monthly — or more often, if a need arises — to discuss newly discovered vulnerabilities. Besides the NSA, the CIA and the FBI, the list includes the Treasury, Commerce and State departments, and the Office of Management and Budget.

The priority is on disclosure, the policy states, to protect core Internet systems, the U.S. economy and critical infrastructure, unless there is “a demonstrable, overriding interest” in using the flaw for intelligence or law enforcement purposes.

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Companies continue to increase transparency of external audit oversight

More companies are providing investors and other stakeholders with information about audit committee oversight of external auditors, according to the latest edition of the Audit Committee Transparency Barometer, an annual report released Wednesday by the Center for Audit Quality (CAQ) and Audit Analytics.

“For the fourth year in a row, audit committees have continued to enhance transparency around their oversight of the external auditor by voluntarily and broadly increasing disclosure,” Cindy Fornelli, executive director of the CAQ, said in a press release. The CAQ is affiliated with the AICPA.

The barometer found that 37% of S&P 500 companies’ proxy statements included enhanced discussions of the factors audit committees considered in recommending the appointment of the external audit firm. That’s up from 31% in 2016 and 13% in 2014.

The analysis, which also looks at mid-cap and small-call companies in the S&P Composite 1500, found that 24% of S&P MidCap 400 companies and 17% of S&P SmallCap 600 companies provided enhanced discussion of audit committee considerations in choosing an audit firm. Those percentages are up from 10% and 8%, respectively, in 2014.

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Misinterpretation of closed Data when Treated with “Normal” Statistical Methods

Geology is among the many branches of science in which compositional data (CoDa) arise naturally. In branches such as geochemistry, compositional data seem to occur typically, when one normalizes raw data or when one obtains the output from a constrained estimation procedure, such as percentages, ppm, ppb, molar concentrations, etc.

Compositional or constrained data have proved difficult to handle statistically because of the awkward constraint that the components of each vector must sum to unity. The special property of compositional data (the fact that the determinations on each specimen sum to a constant) means that the variables involved in the study occur in constrained space defined by the simplex, a restricted part of real space.

It is important for geochemists and geologists in general to be aware of the fact that the usual multivariate statistical techniques are not applicable to compositional data. They need to have access to appropriate techniques as they emerge and become available.

Pearson was the first to point out dangers that may befall the analyst who attempts to interpret correlations between Ratios whose numerators and denominators contain common parts. More recently, Aitchison, Pawlowsky-Glahn, S. Thio, and other statisticians have developed the concept of Compositional Data Analysis, pointing out the dangers of misinterpretation of closed data when treated with “normal” statistical methods.

Learning about all elements of CoDa

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will throw light on all the important aspects of CoDa. At this session, Ricardo Valls, a professional geologist with thirty years in the mining industry, and who has extensive geological, geochemical, and mining experience, managerial skills, and a solid background in research techniques; will be the speaker.

To gain insights into CoDa, please enroll for this webinar by visiting  real case studies developedreal case studies developed

At this session, Ricardo will present several real case studies he has developed, to demonstrate the advantages of applying various aspects of the CoDa analysis in the search for and evaluation of ore bodies by comparing them with regular statistical modelling of geochemical data.

At this webinar, which will be of high value to personnel involved in mining, such as Geologists, Geochemists, Exploration Personnel, Graduate Students, and Post-Graduate Students; Ricardo will cover the following areas:

o  History of the Problem

o  The Current Situation

o  The Model

o  Normal Statistical Processing of the Data

o  Compositional Data Analysis

o  Factor and Principal Component Analysis

o  Dealing with zero and b.d.l. Values

Conclusions and Recommendations.

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Ukraine Will Pursue Hard Reforms This Fall, Finance Minister Says

After a week of back-to-back meetings in Washington, Oleksandr Danylyuk is tired. He gladly downs a cup of coffee before we turn on our microphones to discuss Ukraine’s economy. The affable forty-two-year old finance minister is one of the few reformers left in Ukraine’s Cabinet of Ministers and has a reputation as a doer. He’s in town for the International Monetary Fund’s and World Bank’s annual meetings.

When Danylyuk took over after Natalie Jaresko stepped down in April 2016, expectations weren’t high, but he has exceeded everyone’s expectations. My colleague Anders Åslund captured it well: Danylyuk has “turned out to be the reform anchor in a government that has been less committed to reform than the previous government, and he has managed to keep the state finances in good order.”

The former investment banker managed to render elusive value-added tax refunds automatic, which pleases many foreign businesses, and has presided over a period of modest economic growth. In September, Ukraine returned to the international finance markets with the introduction of a $3 billion Eurobond, and analysts expect that there may be more offerings. Ukraine’s macroeconomic indicators are good, and Danylyuk has become one of the more convincing reform voices within the government—and someone that Ukraine’s formidable civil society actually respects.

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U.S. asks China not to enforce cyber security law

GENEVA (Reuters) – The United States has asked China not to implement its new cyber security law over concerns it could damage global trade in services, a U.S. document published by the World Trade Organization showed on Tuesday.

China ushered in a tough new cyber security law in June, following years of fierce debate around the move that many foreign business groups fear will hit their ability to operate in the country.

The law requires local and overseas firms to submit to security checks and store user data within the country.

The United States, in a document submitted for debate at the WTO Services Council, said if China’s new rules enter into full force in their current form, as expected by the end of 2018, they could impact cross-border services supplied through a commercial presence abroad.

“China’s measures would disrupt, deter, and in many cases, prohibit cross-border transfers of information that are routine in the ordinary course of business,” it said.

“The United States has been communicating these concerns directly to high level officials and relevant authorities in China,” the U.S. document said, adding it wanted to raise awareness among WTO members about the potential impact on trade.

“We request that China refrain from issuing or implementing final measures until such concerns are addressed.”

China’s Ambassador to the WTO Zhang Xiangchen spoke on Tuesday at a WTO conference panel on trade protectionism, which he said was an underestimated problem that was causing a crisis at the WTO.

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