Big Data
Subscribe to Big Data's Posts

FDA Issues Artificial Intelligence/Machine Learning Action Plan

On January 12, 2021, the US Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The Action Plan outlines five actions that FDA intends to take to further its oversight of AI/ML-based SaMD: Further develop the proposed regulatory framework, including through draft guidance on a predetermined change control plan for “learning” ML algorithms FDA intends to publish the draft guidance on the predetermined change control plan in 2021 in order to clarify expectations for SaMD Pre-Specifications (SPS), which explain what “aspects the manufacturer changes through learning,” and Algorithm Change Protocol (ACP), which explains how the “algorithm will learn and change while remaining safe and effective.” The draft guidance will focus on what should be included in an SPS and ACP in order to ensure safety and effectiveness of the AI/ML SaMD algorithms. Other areas of focus...

Continue Reading

OFAC Advisory Warns of Civil Penalties for Ransomware Payments

On October 1, 2020, the US Department of the Treasury’s Office of Foreign Assets Control (OFAC) issued an advisory alert that serves as a warning to entities who have been or will be the victim of a ransomware attack. As such, the crucial decision of whether to pay a ransom now comes with the additional risk of legal scrutiny by a powerful federal agency and the possibility of steep fines. Access the article.

Continue Reading

Uber Criminal Complaint Raises the Stakes for Breach Response

On August 20, 2020, a criminal complaint was filed charging Joseph Sullivan, Uber's former chief security officer, with obstruction of justice and misprision of a felony in connection with an alleged attempted cover-up of a 2016 data breach. These are serious charges for which Mr. Sullivan has the presumption of innocence. At the time of the 2016 data breach, Uber was being investigated by the US Federal Trade Commission (FTC) in connection with a prior data breach that occurred in 2014. According to the complaint, the hackers behind the 2016 breach stole a database containing the personal information of about 57 million Uber users and drivers. The hackers contacted Uber to inform the company of the attack and demanded payment in return for their silence. According to the complaint, Uber's response was to attempt to recast the breach as a legitimate event under Uber's "bug bounty" program and pay a bounty. An affidavit submitted with the complaint portrays a...

Continue Reading

Preparing Your Data for a Post-COVID-19 World

The US healthcare system’s data infrastructure needs an overhaul to prepare for future health crises, streamline patient care, improve data sharing and accessibility among patients, providers and government entities, and move toward the delivery of coordinated care. With insights from leaders from Arcadia, Validic and McDermott, we recently discussed key analyses and updates on the interoperability and application programming interfaces (API) criteria from the 21st Century Cures Act, stakeholder benefits of healthcare data exchange and data submission facilitation for public health purposes. Click here to listen to the webinar recording, and read on for highlights from the program. To learn more about the “Around the Corner” webinar series and attend an upcoming program, click here. PROGRAM INSIGHTS COVID-19 is reshaping healthcare through technology. Hospitals, clinicians and payors need to use digital health tools to address the challenges of the...

Continue Reading

Public Backlash Calls Use of Facial Recognition Systems into Question

In recent weeks and months, legal and technical issues related to use of facial recognition systems in the United States have received national attention, including concerns that the technology lacks accuracy in identifying non-white individuals and that its widespread use by police departments may play a role in racially discriminatory policing. Privacy considerations will play a key role in the ongoing debate over the future of facial recognition technology. Facial recognition systems (FRS) are automated or semi-automated technologies that analyze an individual’s features by extracting facial patterns from video or still images. FRS use attributes or features of an individual’s face to create data that can be used for the unique personal identification of a specific individual. FRS use has grown exponentially in recent years. In addition to widespread adoption by law enforcement agencies, FRS are also frequently used in retail, banking and security sectors,...

Continue Reading

Future Forward: Data Arrangements During and After COVID-19

The need for speedy and more complete access to data is instrumental for healthcare providers, researchers, pharmaceutical, biotech and device companies and public health authorities as they work to quickly identify infection rates, disease trends, outcomes, including antibodies, and opportunities for treatments and vaccines for COVID-19. A variety of data sharing and collaborations have emerged in the wake of this crisis, such as: Requests and mandates by public health authorities, either directly or via providers’ business associates requesting real time information on infections and bed and equipment availability Data sharing collaborations among providers for planning, anticipating and tracking COVID-19 caseloads Data sharing among providers, professional societies and pharmaceutical, biotech and medical device companies in search of testing options, treatment and vaccine solutions, and evaluation of co-morbidities CLICK HERE TO VIEW THE FULL...

Continue Reading

Consumer Demand in Digital Health Data and Innovation

Digital health companies are producing increasingly innovative products at a rapidly accelerating pace, fueled in large part by the expansive healthcare data ecosystem and the data strategies for harnessing the power of that ecosystem. The essential role data strategies play make it imperative to address the data-related legal and regulatory considerations at the outset of the innovation initiative and throughout the development and deployment lifecycle so as to protect your investment in the short and long term. The Evolution of Digital Health Digital health today consists of four key components: electronic health records, data analytics, telehealth, and patient and consumer engagement tools. Electronic health records were most likely first, followed very closely by data analytics. Then telehealth deployment rapidly increased in response to both demand by patients and providers, the improved care delivery and access it offers, and more recently, the expanded...

Continue Reading

Maximizing Your IP Protections in Digital Health

Digital health is experiencing a boom in investment as the regulatory environment becomes more supportive of digital health services. But as companies seek to make the most of their funding and protect the innovations that drive their product, it is imperative that they protect their intellectual property from being copied or duplicated by others in the market. What exactly is IP? Intellectual Property (IP) is generally non-tangible property. You can hold your laptop in your hands or you can stand on a piece of land -- those are both tangible examples of property. Intellectual property cannot be physically held or touched. Protections available for intellectual property generally break down into one of four areas: patents; trade secrets, trademark, and copyright. Patent protection offers an additional layer of protection for digital health solutions compared to copyrights. For example, a company may be eligible for a patent if it has innovated a new approach...

Continue Reading

US Office of Management and Budget Calls for Federal Agencies to Reduce Barriers to Artificial Intelligence

On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory approaches to reducing barriers to the development and adoption of artificial intelligence (AI) technologies. Implementing agencies are agencies that conduct foundational research, develop and deploy AI technologies, provide educational grants, and regulate and provide guidance for applications of AI technologies, as determined by the co-chairs of the National Science and Technology Council (NSTC) Select Committee. To our knowledge, the NTSC has not yet determined which agencies are “implementing agencies” for purposes of the Memorandum. Submission of Agency Plan to OMB The “implementing agencies” have 180 days to submit to OMB their plans for addressing the Memorandum. An agency’s plan must: (1) identify any statutory authorities...

Continue Reading

Challenges and Opportunities in MedTech, Innovation and Digital Health

A recent McDermott roundtable on European health private equity generated key insights into the future of medtech, digital health, and data analytics, and identified opportunities for companies and investors. Digital health solutions are widely considered to be the next big growth market. Healthcare lags significantly behind other industries when it comes to digitization, but the potential opportunities are driving developers, healthcare providers, and investors to find solutions. PATIENT CARE A key point to bear in mind about healthcare technology is that success and adoption may often be measured by the quality of the users’ experience, the resulting clinical outcomes, short and long term cost savings, and the resulting margin for both investors and the health care system at large. These multi-faceted goals are best illustrated by the demands for i) greater efficiency, and ii) better patient outcomes. Efficiency is typified by, for example, streamlined bookings...

Continue Reading

STAY CONNECTED

TOPICS

ARCHIVES