Final Stark Law Regulations Published by CMS

As previously discussed here and on our Health Industry Washington Watch blog here the Centers for Medicare & Medicaid Services (CMS) has released final regulations under the physician self-referral law known as the Stark Law. The provisions of the final rule are effective on January 1, 2016, except for certain changes on calculating ownership percentages for physician-owned hospitals, which are effective January 1, 2017.

For more information on CMS’ changes to the Stark Law, and the implications of those changes for providers seeking to ensure compliance, read the full American Health Lawyers Association Weekly article “CMS Publishes Final Stark Law Regulations” written by Karl Thallner and Nicole Aiken.

ClearCorrect Ruling Keeps ITC From Policing 3D Printing and Other Digital Data Transmission

3D printing has been a common topic of discussion of the blog. We’ve written about it here and in a more in-depth review of the legal issues raised by the emergence of 3D printing in the medical device industry in our September 2015 white paper. 3D printing is in the news again thanks to the recent Federal Circuit ruling in ClearCorrect  Operating LLC v. Intl Trade Comm’n , No. 2014- 1527 (Fed. Cir., Nov. 10, 2015). According to the ruling, the ITC does not have jurisdiction over digital data transmitted into the United States from abroad due to the fact that digital data is not a “material thing.”

The issue at hand in ClearCorrect was that the respondents and accused infringers (ClearCorrect Operating, LLC and ClearCorrect Pakistan, Ltd.) used 3D printers in the United States to manufacture orthodontic aligners using digital models created in Pakistan. The Administrative Law Judge overseeing the ITC investigation found that the methods used to design and manufacture the aligners infringed the petitioner’s (Align Technology, Inc.) patents, and issued cease-and-desist orders against ClearCorrect and ClearCorrect Pakistan forbidding the importation of infringing digital models. The Federal Circuit’s ruling revoked the cease-and-desist order.

To read more about the ClearCorrect ruling and the uncertainty that exists in the legal landscape where intellectual property rights and new digital technologies intersect, read Reed Smith attorney Matthew J. Shiels’ blog post on Technology Law Dispatch here.

U.S.-EU Safe Harbor Framework for Data Sharing

Exactly one month after the Court of Justice of the European Union (CJEU) released its judgment in Maximillian Schrems v Data Protection Commissioner (C-362-14), the European Union released a Communication discussing the implications of their decision on data sharing involving personal information.

This topic is no stranger to the blog, as we’ve posted about it here, authored a recent Reed Smith Client Alert here, and – in light of this most recent EU Communication – we have drafted an even more up-to-date Reed Smith Client Alert here.

Continue Reading

Reminder: Upcoming Life Sciences CLE Day to Take Place at Reed Smith Philadelphia Office

A friendly reminder that the Reed Smith LSHI (Life Sciences Health Industry) Group will be hosting an upcoming November 18, 2015 Life Sciences 1/2 day CLE from 9:00 a.m. ET until 1:30 p.m. ET at their Philadelphia Office. All the details can be found in our previous post here.

Registration and breakfast begin at 8:30 a.m. ET and lunch will be provided. To register for the event, please click here.

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 the Bio-CAD format for 3D printing based on sectional scan image data containing surface and volumetric information, and its proposed standards are intended to address medical 3D printing services such as anatomic and pathologic models and medical-instrument printing.  IEEE also unveiled the Biometrics Open Protocol Standard (BOPS), which is a new eHealth cybersecurity standard designed to protect biometric data exchange.

Earlier this year, Reed Smith’s 3D Printing Task Force published a white paper discussing the spectrum of legal issues raised by 3D printing of medical devices and drugs, from product liability to IP to reimbursement.

Reed Smith to Host New York Event for Deal Dimensions Life Lines: Life Science M&A and the Rise of Personalised Medicine

As reported in Mergermarket’s Deal Dimensions series titled Life lines: Life sciences M&A and the rise of personalised medicine, 94 per cent of life sciences companies are planning an acquisition in the next year, with more than two-thirds (70 per cent) of respondents targeting personalised medicine.

Reed Smith will host a launch event regarding the report in their New York office on Tuesday, December 1st, from 12:00 PM ET – 1:00 PM ET. Report contributors including LSHI attorney Carol Loepere, Diane Frenier and Brian Miner will lead the informal, interactive discussion of the report’s findings over lunch.  Discussion questions will include:

  • What are the main drivers behind the sector’s pursuit for cross-border deals?
  • What are the challenges faced in executing those deals?
  • How may advances in personalized medicine change the face of the industry?

To register for the event, please click here.

Synopsis of Safe Harbor Guidance Issued by European Union Data Protection Authorities

Data privacy issues in the European Union seem to be a reoccurring theme here on the blog, following Court of Justice of the European Union’s judgment in Maximillian Schrems v Data Protection Commissioner (C-362-14)  on October 6. We’ve posted about it here and also had a recent Reed Smith Client Alert here. Last week, European Justice Commissioner Vera Jourova stated that an agreement in principle had been reached with the United States on a new trans-Atlantic data transfer pact, dubbed “Safe Harbor 2.0.” On October 16, the Article 29 Working Party released a coordinated statement, promising a “robust, collective and common position” on the carrying out of the CJEU’s judgment by national Data Protection Authorities.

To view a synopsis of Safe Harbor guidance issued by EU Data Protection Authorities, read the Client Alert written by Cynthia O’Donoghue, Daniel Kadar, Kate Brimsted, Dr. Thomas Fischl, Philip Thomas, Katalina Bateman, Doretta Frangaki, Caroline Gouraud, Chantelle A. Taylor, Tom C. Evans, Dr. Alin Seegel and Dr. Alexander Hardinghaus, LL.M.

Upcoming Reed Smith Webinar on Cross-Border E-Discovery & New Ruling Regarding the US-EU Safe Harbor Framework

The Reed Smith Life Sciences Health Industry (LSHI) Group will be hosting an upcoming webinar “Cross-Border E-Discovery & New Ruling Regarding the US-EU Safe Harbor Framework” on November 24, 2015 from 9:00 a.m. PT, 12:00 p.m. ET, 5:00 p.m. GMT until 10:00 a.m. 1:00 p.m. ET, 6:00 p.m. GMT. Reed Smith presenters including London based Cynthia O’Donoghue, Paris based Daniel Kadar and US based David R. Cohen will be discussing the challenges of cross-border e-discovery  for Life Science and Healthcare Companies. With the recent invalidation of the US-EU Safe Harbor Framework, the waters are now even murkier. During this program, they will provide their take on:

  • Cross-border transfers of data
  • Data protection regulations
  • The landscape without the US-EU Safe Harbor Framework
  • Practical tips for managing cross-border e-discovery

To register for the event, please click here.

HHS’ Selection of Contractor Provides Latest Update on Impending Second Round of HIPAA Audits

On October 27, 2015, a U.S. Department of Health and Human Services (“HHS”) official stated that the agency has hired FCi Federal, a provider of management and professional services to government agencies in Ashburn, VA, to conduct the second round of Health Insurance Portability and Accountability Act (“HIPAA”) data security audits.  Similar to the Phase One HIPAA audits conducted as a pilot program in 2011 and 2012, these audits are used to determine if covered entities and business associates are complying with the Privacy and Security Rules.  Office for Civil Rights (“OCR”) Director Jocelyn Samuels generally stated that the audits will begin “shortly” but that OCR is currently “verifying contact information for the business associates and covered entities that will be included in the Phase Two audit.”  This is aligned with OCR Deputy Director Devin McGraw’s announcement last month that OCR will begin the next round of audits after it submits information about its plan for public comment in late 2015 or early 2016.  Ms. Samuels also provided additional information on the format of the audits stating that Phase Two will consist primarily of desk audits with some on-site audits but that OCR will release an audit protocol as the audits draw closer.

Continue Reading

GAO Report Regarding FDA-Ordered Postmarket Studies

Today, the Government Accountability Office (GAO) released a report entitled “Medical Devices: FDA Ordered Postmarket Studies to Better Understand Safety Issues, and Many Studies Are Ongoing.”   According to the report, “GAO was asked to report on the characteristics and status of postmarket studies. This report describes (1) the types of devices for which FDA has ordered a postapproval study and the status of these studies, and (2) the types of devices for which FDA has ordered a postmarket surveillance study and the status of these studies. GAO analyzed FDA data—including data on medical specialty and study status as of February 2015—for (1) postapproval studies ordered from January 1, 2007, through February 23, 2015, and (2) postmarket surveillance studies ordered from May 1, 2008, through February 24, 2015. These represent the time periods for which FDA reported consistently tracking study data. GAO also reviewed documents, such as FDA guidance, and interviewed FDA officials.”

Continue Reading