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Data Companies Merge to Create Nation’s Largest Health Care Data Ecosystem



Health Data

In a $7 billion transaction, San Francisco-based Datavant is merging with data network company Ciox Health to create the nation’s largest “neutral and secure health data ecosystem.” The combined company will be branded Datavant, connecting patients, providers, payers, health data analytics, government agencies, life science companies and patient applications for secure patient data exchange. 

“The fragmentation of health data is one of the single greatest challenges facing the healthcare system today,” said Pete McCabe, CEO of Ciox Health. 

The COVID-19 pandemic brought to light the level of health data fragmentation, particularly in the US. A lack of centralized healthcare means no centralized healthcare data. These informational silos can result in expensive and redundant care, decreased patient outcomes, less understanding of contributing factors which can lead to the slower discovery of underlying risks and drug interactions. Linking data across these health data silos is critical to solving national healthcare issues during the current pandemic and beyond. 

“Every decision made in healthcare should be informed by data,” said Travis May, CEO of Datavant.  

“Our goal is to create a ubiquitous, trusted, and neutral data ecosystem where parties across the healthcare system can seamlessly and securely exchange data – unlocking better outcomes, faster research, and healthcare at a lower cost. The combined company is positioned to transform America’s health infrastructure and power the health data economy.” 

Co-founded by one of biotech guru Vivek Ramaswamy’s “vants,” Roivant launched Datavant in 2017 to connect the world’s healthcare data. Last spring, Datavant joined a consortium called the COVID-19 Research Database, a secure repository of HIPAA-compliant, de-identified, and limited patient-level data sets made available to public health and policy researchers to extract insights to help combat the pandemic.

With a privacy-preserving patient linking technology, the database is a repository of real-world data, including medical claims, pharmacy claims, electronic health records and demographic data. 

“Roivant created Datavant with Travis because we needed this data ecosystem to exist to fulfill our own mission of accelerating the development of novel medicines for patients,” said Matthew Gline, CEO of Roivant Sciences. “The combination of Datavant and Ciox Health massively expands the reach of that ecosystem and will unlock significant value for us, patients, and for the entire pharmaceutical industry. We look forward to developing additional differentiated technologies at Roivant going forward.” 

Merging with Croix Health, Datavant’s combined ecosystem will include over 2,000 US hospitals, 15,000 clinics, 120 health plans, 100 health data analytic companies, 30 life science companies, 70 academic research institutes and 75 government agencies. 

“Datavant’s groundbreaking tokenization technology and the strength of Ciox’s expanded network across providers, payers, health application developers, and life sciences markets makes this combination compelling,” said R. Martin Chavez, Vice Chairman and Partner at Sixth Street. “We are believers in healthcare technology investment that drives improvement in patient outcomes and attempts to solve our most pressing healthcare challenges. This combination has the potential to enable the US healthcare system to become more patient-centric and data-driven through its breakthrough capability for secure collaboration across all industry stakeholders.” 

Supported by a handful of investors – New Mountain Capital, Roivant Sciences, Merck, LabCorp, Sixth Street and more – the merger is expected to close in the third quarter of 2021. 

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Medical Devices

SCOTUS limits patent judges’ power but preserves PTAB review



The United States Supreme Court ruled Monday that the structure of the country’s patent adjudication tribunal was unconstitutional but declined to eradicate it, instead sending the medical device case at issue to the U.S. Patent and Trademark Office director for further review.

The case centers on whether the decisions of Administrative Patent Judges (APJs) are constitutional under the appointments clause.

In its ruling, the majority held that because APJ determinations during inter partes review (IPR) were not reviewed by the tribunal’s presidentially appointed director, their authority was “incompatible with their appointment by the Secretary of Commerce to an inferior office.”

SCOTUS’ solution? Make sure that someone appointed by the president can overrule their decisions. The justices’ choice? The USPTO director.

“In the end, seven justices said they agree with the court’s proposed remedy, so that is the part of the decision that will have lasting impact: The director now has review authority over all written decisions that PTAB will put out in inter partes reviews,” said Christopher Ricciuti, partner at Oblon, a law firm specializing in intellectual property, in a phone interview. “What remains to be seen is how and how often that power will actually be used.”

According to the justices’ opinion, Smith & Nephew, Inc., and ArthroCare Corp. petitioned for inter partes review of an Arthrex, Inc., patent, and three APJs found the patent invalid. Arthrex appealed, claiming the structure of the PTAB was unconstitutional under the appointments clause.

The Supreme Court has ordered the present case be sent back to the currently acting director, Patent and Trademark Office Commissioner Drew Hirshfeld, for review.

In doing so, it gave Hirshfeld and his followers the authority to review all cases that go through the tribunal moving forward — most notably, its cases centering on inter partes review.

Through inter partes review, PTAB allows companies to challenge existing patents outside of the lengthy patent litigation process by asking the tribunal to reconsider whether they satisfy the requirements that inventions be “novel” (new) and “nonobvious” (i.e., difficult for the average person to come up with on their own). This process has invalidated over 2,000 patents since its inception in 2011.

The ability to do this has been a crucial tool for generics and biosimilars companies seeking to challenge brand medicines’ monopolies without placing their own infringement at issue.

But the question of whether PTAB’s administrative judges are allowed to issue such determinations at all has lingered.

Adjudicating Above Their Constitutional Station

As the court explained in its decision, the APJs were making decisions that should lie with “principal officers.” The problem there is that principal officers must be appointed by the president under advice of the Senate, according to the Constitution’s appointments clause.

The clause allows Congress to assign appointment of “inferior officers,” but those officers are not politically accountable and should therefore have their decisions reviewed by someone in the president’s chain of command, according to the Constitution.

At the PTAB, judges are chosen and overseen by a director who is selected by the president. However, their decisions, which the court called “the final word in the executive branch,” are only reviewed by their fellow APJs, not the director.

“This restriction on review relieves the director of responsibility for the final decisions rendered by APJs under his charge,” the court said.

Chief Justice Roberts delivered the majority opinion, joined in parts I and II by Justices Alito, Gorsuch, Kavanaugh and Barrett, but dissented to in part III by Justice Gorsuch. Justice Breyer issued a separate decision concurring in part and dissenting in part, joined by Justices Sotomayor and Kagan, and Justice Thomas dissented, joined by Justices Breyer, Sotomayor and Kagan as to parts I and II.

The Key: Finality of Decision-Making

The court analyzed its decision on whether PTAB administrative judges were principal or inferior officers based on its prior ruling in Edmond v. United States, which required them to be directed and supervised by someone appointed by the president.

While the Federal Circuit had focused on the director’s role as a supervisor and advisor, SCOTUS said the key to making this determination is where final decision-making power lies. The court looked to its own precedent in Edmond to say that IPR judges were not, at present, acting as inferior officers because their determinations were not evaluated by the tribunal’s director, who is an executive officer.

In their March arguments before the court, the government and Smith & Nephew reasoned that the PTAB director held soft power through the ways they could influence IPR: The director could hire APJs predisposed to deciding “in his preferred manner,” for example.

But, the court countered: “Such machinations blur the lines of accountability demanded by the Appointments Clause and leave the parties with neither an impartial decision by a panel of experts nor a transparent decision for which a politically accountable officer must take responsibility.”

“APJs exercise executive power, and the President must be ultimately responsible for their actions,” the court said.

The Federal Circuit’s Solution? Threaten to Fire Them

The court below wanted to solve the problem by invalidating APJs’ existing tenure protections, saying the Secretary of Commerce could fire them at will.

But SCOTUS said this failed because the Secretary was only allowed to terminate them “for such cause as will promote the efficiency of the service,” not because she disagreed with their rulings.

“The most important practical result of Arthrex for the PTAB’s day-to-day operation is that the tenure protections of administrative patent judges are restored,” said Saurabh Vishnubhakat, a professor at Texas A&M Law School, in an email. “Even for those who thought a constitutional problem existed, making impartial adjudicators decide cases under a cloud of political removal hardly seemed like good public policy — at most, it solved one problem while creating another.”

The High Court’s Fix

To remedy the situation without eradicating the PTAB, the Supreme Court sent Smith & Nephew and Arthrex’s case to the United States Patent and Trademark Office (USPTO) director for review. It further gave the USPTO director power to “issue decisions himself on behalf of the Board,” moving forward.

Notably, while this remedy seeks to maintain the political accountability required in the appointments clause, the current acting PTO director, Drew Hirshfeld, was not politically appointed. Nor is he officially “acting,” according to the Biden administration. He is simply “performing the duties and functions” of a director since Trump-appointed director Andrei Iancu left the position in January, according to an email obtained by Bloomberg.

Still, the court refers to him as “acting director” and is giving him the power to decide whether to rehear Smith & Nephew’s petition, along with a number of others waiting in the wings.

“I expect the director will have the opportunity to decide whether to rehear a number of other cases that were previously remanded to the PTAB and stayed (which had left the status of those patents in limbo pending a decision in Arthrex),” said William H. Milliken, a director at Sterne, Kessler, Goldstein & Fox who issued the firm’s client alert on the case. “However, the mechanics of this review process remain to be seen.”

A Fix With Its Own Potential Problems

“My observation of the USPTO is that in the past, you had the people doing the work on the merits, the APJs, and then the director working on policy objectives — he would never delve into the weeds on the merits of any matter,” said Ricciuti, the Oblon lawyer. “Not only is the director going to be making the policy decisions, but the merit decisions at some level will also rest with the director.”

This seemingly procedural change could raise the stakes on the appointment of USPTO’s next director, Ricciuti explained.

“This decision makes the choice of USPTO director more political: It potentially allows for more lobbying, with interested parties making sure the person is aligned not only on high-level policy but on particular decisions,” Ricciuti said. “There are stakeholders that get their claims brought before PTAB a lot and they might have an interest in swaying the choice of director.”

Recently, top members of the House Subcommittee on Courts, Intellectual Property and the Internet expressed concern with the idea that the USPTO director held such a wide, implicit scope of influence over APJ decisions without the legal authority to do so. The Supreme Court just rendered that power explicit — and legal.

“For those that want to see politics taken out of patent adjudication and protect APJ impartiality, I don’t think this decision necessarily helps,” Ricciuti said.

The case is United States v. Arthrex, — S.Ct. — (2021)

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Medical Devices

Field Safety Corrective Actions : EU MDR Requirements



Field safety corrective actions is one of the pillar process associated to post-market surveillance and its key importance is related to the impact of this specific process to the safety of the devices on the market. We have already been extensively discussing about post-market surveillance, including vigilance reporting, EU MDR requirements related to post-market surveillance, or discussion on specific documents like post-market surveillance plan or periodic safety update report.

In this article we will go through the main requirements associated with the FSCA Process according to EU MDR 2017/745.

What is a Field Safety Corrective Action (FSCA)?

According to the definition reported on the European Commission Guidelines on a Medical Devices Vigilance System MEDDEV 2.12-1, a Field Safety Corrective Action (FSCA) is defined as follows:

“FSCA is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. Such actions should be notified via a field safety notice.”

The definition provided is quite broad, but a field action it may include the following:

  • the return of a medical device to the supplier;
  • device modification;
  • device exchange;
  • device destruction;
  • retrofit by purchaser of the manufacturer’s modification or design change;
  • suggestions provided by the manufacturer regarding the use of the device.

Classic examples of field actions are modification of the devices or of the labelling of the device, software upgrade to fix safety-related issues. Advices to change the way in which the device it used in the clinical practice it is also considered a field action.

Typically, any field action is accompanied by a so-called field safety notice. The definition of field safety notice is also provide on the Guidelines on a Medical Devices Vigilance System MEDDEV 2.12-1:

A communication to customers and/or USERs sent out by a MANUFACTURER or its representative in relation to a Field Safety Corrective Action. 

In other words, the FSN (Field Safety Notice) is the explanation or communication to the customer in relation to a FSCA.

It is important to mention that an FSCA does not arise when a manufacturer is exchanging or upgrading devices in the absence of a safety risk or when actions on the market (for example, removal of the device from the market) are for purely commercial reasons.

EU MDR Requirements for FSCA

The requirements for the FSCA in relation to the EU MDR 2017/745 are reported the Article 87(b). In this article, it is explained that manufacturers shall report to the relevant competent authorities

“any field safety corrective action in respect of devices made  available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for  the field safety corrective action is not limited to the device made  available in the third country”.

This set the obligation of the manufacturer to inform the relevant competent authorities in case of FSCA. Moreover, always in Article 87 it is clearly mentioned:

Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in point (b) of paragraph 1 in advance of the field safety corrective action being undertaken.

Basically, it means that the field safety notice shall always precede the field safety corrective action, unless the safety of the patients is at risk and the field action needs to be taken immediately.

Analysis of Field Safety Corrective Actions

In the Article 89 of the EU MDR 2017/745 there are additional requirements related to the Field Actions. Specifically, it is mentioned:

  • the field safety corrective action taken shall be brought without delay to the attention of users of the device in question by means of a field safety notice.
  • The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the FSCA is taken.
  • The content of the draft field safety notice shall be submitted to the evaluating competent authority (unless in case of urgency).
  • Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States.

Moreover, some requirements related to traceability in the Field Action process are also mentioned in the Article 89. Specifically, the FSCA shall allow the identification of the device(s) involved, including the UDIs, and identification of the manufacturers (for example, the SRN of the manufacturer that has undertaken the field safety corrective action).

Field Actions and Risk Management Process

Risk management process has been the subject of many posts and discussion through the QualityMedDev blog post. We have been discussing of different topics ranging from the risk analysis to risk-benefit analysis, until to arrive to the risk management plan.

The process of field action is strictly linked with risk management. In fact the manufacturer shall take a decision when an FSCA is needed and this decision is typically based on the following:

  1. The hazard arising from the device shortcoming
  2. The probability of the hazard occurring
  3. Whether the risk outweighs any possible hazard caused by the FSCA due to itstemporary/permanent removal from use, modification, exchange, retrofit or due to new advice being provided by the manufacturer.

As you can see, the decision is always based on risk-related considerations. This is why it is essential to have a solid risk management process to ensure adequate decisions are taken when safety of the patient is under discussion.

QualityMedDev Newsletter

QualityMedDev is an online platform that provides extensive support to medical device manufacturers and consultancy companies in the field of regulatory compliance. We publish blog posts on quality management system and regulatory-related topics and provide extensive documentation ready to be downloaded to support the implementation and maintenance quality system or product-related certifications. QualityMedDev provides consulting service for quality and regulatory affairs topic for medical device manufacturers, do not hesitate to find out more on our services in the dedicated page of the website. We support the construction of brand new quality system and/or preparation of SW related technical documentation.

We publish as well a periodic newsletter aimed at sharing information on the new articles or documents which have been made available through QualityMedDev website.

A discount of 10% is available for purchase value of minimum 50€ in our QualityMedDev DocShop by using the following Coupon Code FBT2WDX5.

If you would like to stay updated with the last news and analysis from the regulatory world for medical device sector, do subscribe to our newsletter by filling the form below.

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Medical Devices

UNITY-B Percutaneous Balloon Expandable Biodegradable Biliary Stent Receives European CE Mark



UNITY-B Percutaneous Balloon Expandable Biodegradable Biliary Stent has received CE mark approval according to QualiMed Innovative Medizinprodukte GmbH, a wholly-owned subsidiary of Dublin, Ireland based Q3 Medical Devices Limited (Q3).

UNITY-B Percutaneous Balloon Expandable Biodegradable Biliary Stent (BEBS) was developed for the percutaneous treatment of hepatobiliary obstruction requiring large opening drainage with the added benefit of eliminating removal procedures associated with traditional non-degradable implants. Before the recent introduction of biodegradable biliary and pancreatic drainage devices, biliary and pancreatic duct implants were made of non-degrading plastics or metals. These traditional plastic and metal implants typically require multiple procedures to place the stents, treat associated complications, and remove the implants as their removal is mandatory in most cases. The removal requirement associated with the traditional implants has the effect of doubling the total cost of care by requiring two (2) operations (1 for the device implant & 1 for the device removal) versus one (1) operation (1 for the device implant) for the biodegradable devices. Biodegradable devices have the added benefit of dissolving in the body after they have completed their work.

The UNITY-B biodegradable stent is a large diameter balloon-expandable biodegradable implant that is introduced percutaneously and is intended to facilitate the drainage of obstructed ducts requiring larger openings. The UNITY-B biodegradable stent is designed to replace the estimated 1 Billion Euro plus the global market for non-degradable metal biliary implants. The UNITY-B biodegradable percutaneous stent was developed as an alternative to avoid the second removal procedures required with the traditional covered and uncovered metallic stents. The QualiMed percutaneous biodegradable balloon-expandable implant provides an advanced treatment option to the traditional plastic and metallic implants used by Gastroenterologists, Surgeons, and Interventional Radiologists to reduce the total cost of care and complications associated with the older generation of non-biodegradable plastic and metallic implants.

The UNITY-B Biodegradable Stent is designed based on the functionality of Musculoskeletal System (Bone and Muscle) where the biodegradable magnesium alloy mimics the bone and the polymer acts more like the muscle. The Skeletal (Magnesium) portion of the system serves as the main support structure. The Muscle (Polymer) helps to support movement and stability eliminating the shortcomings found in 1st generation biodegradable technology.

In a recent safety and efficacy clinical study conducted, the UNITY-B biodegradable system showed no (0) Adverse Events and no (0) Serious Adverse Events reported as related or even possibly related to the UNITY-B study device. “The final clinical success evaluation resulted to a success rate of 94.4% which is outstanding in comparison to the ESGE 2012 guideline for traditional products, which just for stent dysfunction already reports 41%, 27% and 20% failure rate for plastic stents, uncovered SEMS (self-expandable metallic stents) and covered SEMS, respectively.

Doctor Pérez-Cuadrado-Robles, an interventionalist stated, “The UNITY-B Biodegradable Stent will become a new paradigm in the management of pancreatobiliary diseases.  Patients with a variety of indications, such as benign biliary strictures, biliary stones, prevention of post-sphincterotomy bleeding, biliary leaks etc. can be candidates to this technology. Indeed, this intuitive and outstanding stent can prevent second-look procedures and their procedure-related complications, resulting in a cost-effective and safe approach. Notably, the UNITY-B has major advantages in patients with a difficult access to the biliary duct (i.e., surgical anatomy). For all these reasons, this new technology should be an integral part in the management of pancreatobiliary diseases armamentarium.”

“The CE mark approval of the UNITY-B Percutaneous Biodegradable implant represents yet another milestone for QualiMed and all the companies of Q3 Medical and our collective mission of Creating Value By Helping People. In these uncertain times, being able to provide total cost of care cost-saving using advanced, clinically proven products is more important than ever,” said Eric K. Mangiardi, CEO of Q3. “As we continue the development of additional biodegradable technologies to expand our portfolio for use in the gastrointestinal tract and peripheral vasculature, we are striving to shift the paradigm for treatments by reducing complications and eliminating the need for additional removal procedures or latent complications associated with the current treatment options.

“This device opens a new era in biodegradable advancements that are easy to use and similar to the current technology so no additional training is needed. The technology also has the additional benefit of potentially eliminating the second procedure required for stent removal with the traditional technology and eliminating the cost of care for the patients and the insurance providers. With its reliable degradation profile, ease of use, and cost-saving benefits the device will surely see the utility in other applications throughout the gastrointestinal and peripheral vasculature,” said Professor of Radiology Gianpaolo Carrafiello, from the University of Milano, Milano, Italy.

It is an exciting time for the company stated Eric Mangiardi, CEO of Q3 Medical as “this is only the beginning of the creative journey developing biodegradable implants for use by interventionalists and surgeons in the gastrointestinal tract as a 1st step and in the vasculature as a 2nd step. The company plans to continue its development for a variety of vascular indications including the commercialization of a specialty biodegradable implants for vascular dissections and occlusions including biodegradable covered versions of the UNITY Platform. To date Q3 Medical through its portfolio companies like QualiMed, AMG, Qsan, and QualiMed USA has 5 unique differentiated biodegradable products CE approved for treatment of a wide range of gastrointestinal indications in the hepatobiliary tract. The companies are focused on additional developments to expand the biodegradable product offering in the gastrointestinal and peripheral vascular areas.

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Medical Devices

QuickSee Handheld Autorefractor Can Dramatically Increase Access to Eyeglasses According to a Study



The study authors suggest that QuickSee, due to its accuracy and portability, could be used to radically expand access to eyeglasses in remote and low resource settings which lack professionals and clinical equipment to provide accurate prescriptions.

Uncorrected refractive error is a matter of major global concern, including wealthy nations. A report published by The Lancet in February 2021, “The Lancet Global Health Commission on Global Eye Health: vision beyond 2020,” estimated that over 1 billion people worldwide had distance- or near-vision impairment, resulting in at least $410 billion in productivity loss annually. The authors also highlighted the impact of poor vision on quality of life, education, and workforce opportunities, noting that vision correction would support a number of the UN’s Sustainable Development Goals. This is the challenge PlenOptika set out to solve.

“These encouraging findings support our belief that the global burden of vision impairment can be met with innovative technology, not only in low- and middle-income countries, but also in wealthy countries like the US where vision care disparities persist,” said Shivang Dave, PhD, CEO of PlenOptika and one of QuickSee’s inventors. He and his colleagues in PlenOptika, Daryl Lim, PhD, Eduardo Lage, PhD, and Nicholas Durr, PhD, invented the technology while researchers at the Massachusetts Institute of Technology, in collaboration with the Regional Government of Madrid. QuickSee development was supported in part by grants from the National Eye Institute of the National Institutes of Health.

In wealthy nations where patients have access to licensed health care providers, QuickSee’s technology has also helped eye doctors provide on-site care, such as in nursing homes, correctional facilities, and community health centers. Even large eye health centers are using QuickSee to manage large patient volumes efficiently.

Lage, PlenOptika’s Chief Technology Officer, noted that impact in global health was QuickSee’s central design objective. “Portable, durable, easy to use, and affordable, all without sacrificing clinical quality, that was our mission,” he said. “It is gratifying that independent research affirms QuickSee’s capability to achieve this.”

To date, QuickSee has been used to measure over three million people in 45 countries, and was found in prior peer-reviewed studies to produce measurements that strongly agree with subjective refraction.

“Our goal with QuickSee is nothing short of making accurate autorefraction accessible to everyone, everywhere, enhancing their opportunities and enabling the wonder of clear vision,” said Dave. “We hope this research gives vision care professionals, healthcare organizations, and NGOs the confidence that QuickSee will be instrumental in their work to dramatically increase access to vision correction.”

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