What is your company’s approach to qualifying a software service provider and managing software-as-a-service (SaaS) for cybersecurity? The need for qualifying and managing your software service provider Most of the productivity gains of the past decade are related to the integrartion of software tools into our business processes. In the past, software licenses were a […]

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According to an article published in Nature Biotechnology, Harvard and MIT researchers invented a face mask for detecting SARS-CoV-2, the virus that causes COVID-19, via a user’s breath.  Instead of relying on a lab, the personal device uses sensors that use wearable freeze-dried cell-free (wFDCF) technology.  This technology contains the same molecules that cells use to recognize and manipulate nucleic acids and proteins.  According to MedGadget, unlike previous iterations of this technology which store living cells in “tiny aquariums”, wFDCF technology prevents any issues with leakage due to breakage.

To use the mask, a user presses a button on the mask to release water onto reactive wFDCF sensors.  MedGadget reports that results are given within 90 minutes and can be displayed on the inside of the mask for privacy purposes.  According to the scientific article, the wFDCF technology first cleaves viral particle samples in order to release the viral RNA.  Next, target genes located in the viral RNA are amplified via reverse transcription–recombinase polymerase amplification, in order to amplify the sequence that encodes for the spike protein.  A lateral flow assay strip is then used to display visual results similar to a pregnancy test.

“We have essentially shrunk an entire diagnostic laboratory down into a small, synthetic biology-based sensor that works with any face mask, and combines the high accuracy of PCR tests with the speed and low cost of antigen tests,” said researcher Peter Nguyen.  “In addition to face masks, our programmable biosensors can be integrated into other garments [e.g., lab coats] to provide on-the-go detection of dangerous substances including viruses, bacteria, toxins, and chemical agents.”

MIT News reports that the device can also swap in sensors for other pathogens, including influenza, Ebola, and Zika, or sensors they have developed to detect organophosphate nerve agents.

Genetic Engineering and Biotechnology News reports that the research team is “actively searching for manufacturing partners who are interested in helping to enable the mass production of the face mask diagnostic for use during the COVID-19 pandemic, as well as for detecting other biological and environmental hazards.”  The article reports that the authors have already submitted provisional patent applications for the technology.

The original article was published in Nature Biotechnology on June 28, 2021, and is available here.

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We desperately need to find a way to get more customer feedback and suggestions for product improvement, but what is the best way to do that? Surveys rarely have a high response rate, but we need to gather customer feedback. Therefore, we created this blog posting as a living document of how we are trying […]

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The post New to the Street August 8th, 2021 | Clubhouse Media Group, FINXFLO, SportemonGo, Gaensel Energy Group, Solar Integrated Roofing, GlobeX Data, RushNet, Sekur appeared first on Exploring the Block.

In this blog post I summarized the potential legal liability of issuers raising capital using Title II Crowdfunding (aka Rule 506(c)), Title III Crowdfunding (aka Reg CF), and Title IV Crowdfunding (aka Regulation A). Here, I’ll summarize the potential legal liability of a registered Title III funding portal. To start, let’s distinguish between two kinds …

Continue reading The Legal Liability of A TITLE III Funding Portal

A recent report from the Future of Privacy Forum [PDF] sets out recommendations to tackle the privacy risks associated with immersive augmented (AR) and virtual-reality (VR) technologies that are increasingly being implemented in education and training, gaming, multimedia, navigation and communication.

As AR and VR applications that let users explore a shared digital overlay of the physical world in real-time become more widely adopted and improved, they will likely converge into one ‘extended reality’, or XR. These technologies accumulate and process vast amounts of sensitive personal information including biometric data, unique device identifiers, location and information about homes and businesses. Like other emerging technologies such as artificial intelligence and 5G communications, however, this creates a risk to data subjects that could undermine the further adoption of AR and VR platforms by limiting their usefulness. Without this data, XR technologies simply cannot function.

The Future of Privacy Forum is a think tank that brings together academics, consumer advocates and industry to explore the challenges posed by technological innovation and to develop privacy protections, ethical norms and workable business practices. The purpose of its report is to consider current and future use-cases for XR technologies and provide recommendations for industry to implement them responsibly through the adoption of privacy guidelines. This includes advice for policymakers who need to consider how their data-protection law obligations are implemented in regard to the collection of personal data by XR technologies; for example, how hardware manufacturers maintain transparency in their data collection, use and sharing as well as how developers can process data locally.

The report makes several key recommendations. First, that policymakers should carefully consider how existing or proposed data-protection laws can provide consumers with meaningful rights and companies with clear obligations regarding XR data. It also suggests that hardware makers should consider how XR data collection, use and sharing can be performed in ways which are transparent to users, bystanders and other stakeholders.

For their part, XR developers should consider the extent to which sensitive personal data can be processed locally and kept on-device, while ensuring that sensitive personal data is encrypted in transit and at rest.

Platforms and XR experience providers should implement rules about virtual identity and property that mitigate, rather than increase, online harassment, digital vandalism and fraud. They also need to establish clear guidelines that mitigate physical risks to XR users and bystanders, and provide a wide range of customisable avatar features that reflect the broader community, encouraging representation and inclusion.

It’s also their responsibility to consult with the larger community of stakeholders including industry experts, advocates, policymakers, XR users and non-XR users, and integrate community feedback into decisions about software and hardware design and data collection, use and sharing.

For their part, researchers working in this area need to obtain informed consent prior to conducting research via XR technologies and consider seeking review by an institutional or ethical review board if consent is impractical.

Many of these recommendations are aimed at industry and the considerations are best reflected within privacy policies as well as end-user license agreements (EULAs). The difficulty with attempting to retrofit existing policies and agreements for this industry is that they run the risk of not fully appreciating the way these technologies operate. The usual box-ticking method of agreeing to EULAs and privacy policies common with software and websites may not fit so easily into XR.

The extensive personal data collected by XR technologies helps create better immersive experiences, but it can also exacerbate privacy risks – the unique nature of these technologies makes it difficult to mitigate risks by applying existing privacy policies and practices from other digital media sectors and requires new innovative approaches to choice, security and transparency. For example, VR headsets can capture large amounts of personal data such as dexterity, ease of movement and reaction times, potentially building up a health profile – eye-tracking technology is far more intrusive than cookies.

VR manufacturers need to ensure privacy is protected and data processed and stored securely – and only if they have the express consent to do so. They should also consider, where a device’s processing of medical data assists with diagnosis or treatment, whether medical device authorisation is necessary and whether the privacy risks arising from research could be mitigated by data anonymisation.

The FPF recommendations aim to provide a way for industry and policymakers to tackle this without compromising the benefits provided by XR technologies. The report considers that XR technologies are ever-evolving and seeks to address this by focusing on actual harms tied to user data.

The desired outcome is clearly for policymakers to work within an innovation-friendly regulatory environment by clarifying and harmonising existing rules and introducing industry-standard recommendations specifically tailored for the XR industry. The best way to do this is for industry and policymakers to get behind recommendations such as those provided by the FPF and consider how best to implement these within their existing practices.

Rayyan Mughal is a commercial contract lawyer and associate with Marks & Clerk.

Next Blog Alternative energy based on the use of fuel cells is gaining more and more popularity and is increasingly being used in the automotive, aerospace, and energy industries as well as other sectors of the economy. What is a Fuel Cell? Fuel cells (FC) are electrochemical devices which convert the chemical energy of a Read More...

The post An Introduction to Fuel Cells: What Are They, How Do They Work, and How Can We Improve Their Efficiency? first appeared on Turbomachinery blog.

How much does a 510k cost is the most common question I receive from customers, and there are three parts to the cost of a 510k. If you want to save $9,559 on your 510k cost of submission to the FDA, you need to listen to ALL of this video and follow every single step […]

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The U.S. Supreme Court recently decided a case resolving a patent dispute between two medical device companies, Hologic, Inc. and Minerva Surgical.  The opinion was closely watched because it raised the question of whether an inventor who has assigned a patent is legally prevented from later attacking the validity of that same patent — a doctrine historically referred to as “assignor estoppel.”

The Supreme Court’s opinion on June 29, 2021, upheld but limited this doctrine, defining its boundaries and emphasizing it is based on legal principles of equity and fair dealing.

In the case, Csaba Truckai was a listed inventor on a patent application, the rights to which were subsequently acquired by Hologic, Inc. Mr. Truckai then founded Minerva Surgical, Inc. and developed an endometrial ablation system.  Hologic sued Minerva for patent infringement of one of the assigned patents related to endometrial ablation.

In response to the claims of patent infringement, Minerva attacked the patent as allegedly invalid. In response, Hologic argued that, under assignor estoppel, Minerva should be prevented from attacking the patent’s validity because Minerva’s founder, Mr. Truckai, was an inventor on the same patent.

In deciding the case, the Court recognized the fairness principle of assignor estoppel — that an inventor shouldn’t be able to initially tout an invention to the patent office, only to later disclaim its worth after assigning it. However, the Court decided that the lower court had applied assignor estoppel too expansively to muzzle inventors.  Thus, the Court held that the doctrine applies only when an inventor makes statements (explicitly or implicitly) in assigning a patent, and later contradicts those statements in litigating against the owner of the patent. The Court reasoned that an assignment does carry an implied assurance of a patent’s validity, but where the assignor has not made explicit or implicit representations that contradict an invalidity defense, there is no ground for assignor estoppel.

To illustrate the boundaries of assignor estoppel, the Court provided three non-exhaustive examples of when assignor estoppel does not apply:

• First, when assignment occurs before an inventor can make a warranty of validity (e.g., “when an employee assigns to his employer patent rights in any future inventions he may develop during his employment”);
• Second, when a later legal development renders the warranty of validity irrelevant (such as a change in the law); and
• Third, when a change in patent claims occurs for an assigned application (e.g., “the new claims are materially broadened” during patent prosecution after the assignment takes place).

Nevertheless, each assignor’s and each company’s situation is unique, and the application of assignor estoppel depends on the particular situation. Medical device companies and others concerned about patents should seek the guidance of professional legal counsel when making any determination regarding whether assignor estoppel applies.

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