Tag Archives: health technology

HIPAA-Regulated Entities Take Notice – States are Teaming Up on Enforcement

In an unprecedented settlement arising from a federal lawsuit in the U.S. District Court for the Northern District of Indiana, a medical software provider agreed to pay $900,000 to 16 state attorneys general (AGs) for alleged violations of a conglomerate of state and federal privacy laws. The settlement represents the resolution of the first-ever multistate data … Continue Reading

AdvaMed Issues Revised Code of Ethics on Interactions with U.S. Health Care Professionals

The Advanced Medical Technology Association (AdvaMed) – the national industry association of medical technology manufacturers – recently issued an updated Code of Ethics on Interactions with Health Care Professionals (HCPs) (the AdvaMed Code or Code). Last revised in 2009, AdvaMed’s updated Code will go into effect January 1, 2020. The Code speaks to the evolving … Continue Reading

FDA Announces Its Plan for Encouraging Reliance on Newer Predicate Devices and Medical Device Performance Criteria

On November 26, 2018, the Food & Drug Administration (FDA) announced its intent “to modernize the FDA’s 510(k) clearance pathway”1 by encouraging manufacturers to rely on newer (that is, 10 years old or less) medical devices as predicate devices in 510(k) notifications, and providing an alternative 510(k) pathway that allows manufacturers to rely on objective … Continue Reading

FDA to implement OIG suggestions on IoT cybersecurity

The Office of the Inspector General (OIG) published a report in September 2018 after a review of the Food and Drug Administration’s (FDA) policies, procedures, and guidance relating to cybersecurity reviews of networked medical1 devices. In its findings, covered in our recent client alert, the OIG determined that while the FDA has started to include … Continue Reading

FDA Announces Plans to Improve Safety and Advance Innovation of Medical Devices

On April 17, 2018, FDA announced its plan to launch the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (Action Plan), which aims to support and advance innovation in medical devices while also assuring the safety of the devices throughout their Total Product Life Cycle (TPLC). To that end, FDA intends to focus … Continue Reading

FDA Presents Webinar on Technical Considerations for Additive Manufactured Medical Devices

On December 5, 2017, the U.S. Food and Drug Administration (FDA) released the final version of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff.” As a follow up to the Guidance’s release the FDA held a webinar on January 10, 2017, to present an … Continue Reading

Is Your Software a Medical Device? FDA Weighs-in with New Draft Guidances

On December 8, 2017 – nearly a year after President Obama signed into law the 21st Century Cures Act (“Cures Act”) – the Food and Drug Administration (“FDA”) released two new draft guidances that aim to implement section 3060 of the Cures Act, and provide clarity on the Agency’s regulatory approach to software as a … Continue Reading

Senate Bill Seeks to Provide “Floor” for Cybersecurity Operational Standards for Internet-Connected Devices Purchased by Federal Agencies

A recent bill introduced by Sen. Mark Warner (D-Va.) is attempting to place heightened security standards on all Internet of Things (IoT) devices procured by any federal agency. Should the legislation be enacted, the expectations it sets forth regarding the security of IoT devices could be interpreted by courts as the minimal floor for any … Continue Reading

FDA Guidance Offers Initial Thoughts on Technical Considerations Specific to Medical Devices Using 3D Printing

The U.S. Food and Drug Administration (FDA) announced the availability of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff,” which was published in the Federal Register. This guidance was previously circulated in May 2016 in a draft form and underwent a comment period, where … Continue Reading

FDA Finalizes Policy for Sharing Patient-Specific Data from Medical Devices

FDA recently released guidance (“Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request”) finalizing its policy on medical device manufacturers sharing patient-specific information from devices with patients at the patients’ request. In response to the more active roles patients are playing in their health care, and increased frequency with which patients are seeking … Continue Reading

Upcoming Free CLE Webinar: “The Internet of Things’ Impact on the Health Care Industry: Diagnosing the Dangers with Disruptive Technology”

Reed Smith not only assists our pharmaceutical and medical device clients with their current legal challenges and opportunities, we look around corners to anticipate the next industry disruptor – and to help our clients navigate the legal issues that come with it. For our life sciences clients, the Internet of Things is clearly a game … Continue Reading

Upcoming Free CLE Webinar: “3D Printing: Component Parts/Raw Materials Product Liability & Health Risks”

Reed Smith is at the forefront of thought leadership surrounding 3D printing and how this revolutionary technology will impact our pharmaceutical and medical device clients, as well as universities and other leading medical centers which are incorporating this technology into patient care. Our 3D printing team has authored two white papers (available here and here) … Continue Reading

Upcoming Free CLE Webinar: “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers”

The Reed Smith life sciences product liability and 3D printing teams will be hosting an upcoming CLE webinar “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers” on May 8, 2017 at 12 p.m. ET. Reed Smith presenters Jim Beck and Matt Jacobson will be discussing 3D … Continue Reading

FDA Consumer Update: The 3Rs of 3D Printing – FDA’s Role

On December 21, 2016, the U.S. Food and Drug Administration (“FDA”) posted a Consumer Update and accompanying video on the “The 3Rs of 3D Printing: FDA’s Role,”  which reconfirms its position on the importance of 3D printed medical devices.  The FDA sums up its role in this “innovative space” as regulate, research, and resource (i.e., … Continue Reading

Reed Smith Launches Second Edition of 3D Printing White Paper

Following up the success of its first, medical device-focused 3D printing white paper, 3D Printing of Medical Devices:  When a Novel Technology Meets Traditional Legal Principles, Reed Smith’s 3D Printing Task Force has now launched a second edition of its 3D printing publication white paper addressing 3D printed products more broadly:  3D Printing of Manufactured Goods: … Continue Reading

FDA Publishes Draft Guidance Regarding 3D Printing Of Medical Devices

The U.S. Food and Drug Administration (FDA) has approved more than 80 medical devices that involve 3D printing and one prescription drug.  It also held a public workshop to obtain information and input about 3D printing issues on October 8 and 9, 2014.  FDA brought together technical 3D printing expertise from various industries and sectors … Continue Reading

IEEE Developing New Standards for 3D Printers For Medical Uses

The Institute of Electrical and Electronics Engineers Standards Association (IEEE) is developing new interoperability standards for medical devices, 3D printers and other eHealth devices.  IEEE P3333.2.5, Draft Standard for Bio-CAD File Format for Medical 3D Printing is intended to develop standard methods for the printing of 3D-printed prosthetics and medical devices.  IEEE proposes to define … Continue Reading

3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles

3D printing is quite possibly the next greatest chapter in the industrial revolution, and the technology is moving rapidly.  Reed Smith’s Life Sciences Health Industry Group recently launched its first 3D printing publication white paper – 3D Printing of Medical Devices:  When a Novel Technology Meets Traditional Legal Principles.  This paper explores unchartered legal issues … Continue Reading

21st Century Cures Markup Underway; Offsets Released

Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability of health technology, … Continue Reading

3D Printing Medical Devices

3D printing is providing physicians with a steady flow of new options for medical treatment. Reports are constantly emerging about novel, life-saving procedures made possible through 3D printing. As one might imagine, however, 3D printing a medical device for use in humans carries particular challenges not present with 3D printing in other contexts.… Continue Reading

Bipartisan Energy & Commerce Committee Leaders Release Updated 21st Century Cures Draft

The bipartisan leadership of the House Energy and Commerce Committee has released their 2015 version of the 21st Century Cures Act, which is intended to bolster medical discovery, treatment development and delivery of treatment to patients. The nearly 200-page legislation is the product of a year-long collaboration between lawmakers and stakeholders.… Continue Reading
LexBlog