PK Law Attorneys Named to 2017 Super Lawyer Maryland List

Congratulations to the Following PK Law Attorneys on their selection to the 2017 Super Lawyer Maryland List (Top 5% of MD Attorneys)

Steven Allen
James Benjamin Jr.
Joan Cerniglia-Lowensen
Gregory Kirby
Thomson Kohn
Patricia Lambert
Michael Leaf
Natalie Magdeburger
Mairi Pat Maguire
Mark Maneche
David Pessin
Lisa Settles
Catherine Steiner
Drake Zaharris

And 2017 Super Lawyer Maryland Rising Stars List (Next Top 2.5% After Super Lawyers List, Practicing Less than 10 Years and under 40 years of Age)

David Burkhouse
Brian Cathell
Chantelle Custodio
Cheryl Jones
Kayleigh Keilty
Talley Kovacs
Andrew Scott
Aidan Smith

We congratulate these attorneys as this shows their dedication to PK Law clients and professionalism within the legal field.

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About Pessin Katz Law, P.A. (PK Law)

PK Law is a leading Maryland law firm with more than 60 attorneys, paralegals and law clerks. The firm’s main office is located in Towson with offices in Columbia and Bel Air. PK Law’s core practice areas include Corporate and Real Estate, Education Law, Employment Law, Estate Planning and Elder Law, Litigation and Medical Malpractice Defense. www.pklaw.com

President Obama Signs “21st Century Cures Act”

On December 13th the President signed into law the “21st Century Cures Act” (H.R. 34, PL 114-255 (the “Act”)).  The legislation has been hailed as a variety of things including a tribute to Vice President Joe Biden; evidence of bipartisan cooperation in Congress; the most important health-related legislation since Obamacare; and a terrible piece of “pork barrel” legislation.  (Legislation which favors specific interests in Congress.)  What effect the election of Donald Trump and a Republican Congress may have on the Act is unclear, but certain provisions, no matter how they are influenced by subsequent events, are important to note.

  • The Act does not contain an exemption which would have negated the requirement that drug and medical device makers report payments to physicians under a federal database established in 2014. The database tracks those types of financial relationships.  That program, known and referred to as Open Payments, was part of the Affordable Care Act (“Obamacare”) and was established under the theory that fees for speaking engagements on products, free textbooks, and the like, might influence prescribing by the physicians involved with those activities.
    • Much focus is on the U.S. Food and Drug Administration which is provided $500 million over ten years to implement speedier FDA approval of regulated health care items.
    • The National Institutes of Health will receive $10 billion over 10 years for cancer and stem cell research.
    • States will receive $1 billion for grants for opioid abuse treatment and prevention.
    • Administrative burdens on researchers will be lessened.
    • Efforts will be made to establish a global network devoted to pediatric study.
    • Patient experience data will now be included in a statement attached to a drug’s approval by the FDA, such experiences to include not only those of patients but also those in a broad range of persons, organizations and institutions associated with patients.
    • The FDA will be required to issue guidance on the manner in which patient experience is to be collected and submitted and how that data will be used.
    • The FDA is permitted to bypass Paperwork Reduction Act requirements when seeking information from patients regarding their treatment so as to provide timely feedback from patients on the same.
    • The FDA must report its review of patient experience data and information on patient=focused drug development tools according to a timeline in the Act.
    • The Act establishes a review “pathway” for drug development tools to attempt to shorten drug development times and improve success in drug development.
    • Regarding rare diseases, the Act clarifies the manner in which certain drug developers may rely on data for the same or similar technology from earlier approved applications by the same developer without altering standards.
    • The FDA will have authority to waive or alter informed consent requirements for clinical trials with minimal risks associated with them.
    • The Act allows the FDA to grant swifter approval for “regenerative therapeutic products”. Regulations and guidance regarding such products are to be updated by the FDA.
    • Regulations are to be promulgated to allow the best manner in which the FDA may approve “combination products”, those allowing a medical device and biologic to be used together in treatment, and how disagreements within the FDA on the same are to be resolved.
    • The FDA is granted more flexibility to approve certain drugs based on a “limited population” if the drug is designed to treat a life-threatening infection.
    • Sponsors of devices will no longer be required to use a local institutional review board in seeking FDA approvals, instead employing the use of centralized models for review.
    • Audits of FDA reviews are to be conducted by the FDA ombudsman in an attempt to ensure and track that the least burdensome means are being employed by the FDA in the drug and device approval process.
    • The Act identifies five categories of medical software that will not be classified as “devices” if certain conditions are met.

The foregoing are just a few of the highlights of the Act’s 996 pages. For additional information on the Act or other legal matters contact one of PK Law’s Attorneys or information@pklaw.com.

 

This information is provided for general information only. None of the information provided herein should be construed as providing legal advice or a separate attorney client relationship. Applicability of the legal principles discussed may differ substantially in individual situations. You should not act upon the information presented herein without consulting an attorney of your choice about your particular situation. While PK Law has taken reasonable efforts to insure the accuracy of this material, the accuracy cannot be guaranteed and PK Law makes no warranties or representations as to its accuracy.

Website Accessiblity – An Introduction to the Problem and Best Practices for Education Agencies and Schools

College students sitting in a classroom, using laptop computers during class (shallow DOF)

Are you reading this article on a computer?  I would venture to guess that you are.  How did you access this page?  Did you have to navigate through multiple web pages?  While you were at it, were you surfing the internet, doing some online shopping, watching a video, reading some other articles on the web?  My guess is that many of you already did (or will likely do so after reading this piece).

We use computers at school, at work, and at home.  Every day, we log on to websites to conduct research, to shop, to check the news, to listen to music, and even to watch shows and movies.  The internet has become an indispensable tool for nearly every facet of life.

When most people log onto a website, they take for granted their ability to read a webpage, navigate links, click through web-content, and consume media.  Yet, for many people, parts of the web are inaccessible and unusable.  Blind individuals, individuals with low vision, individuals with limited manual dexterity, and individuals who are deaf or hard of hearing are adversely impacted by websites that are either incompatible with assistive technology or that lack features that enable these individuals to access and comprehend the website.   For these individuals, using the internet can be a cumbersome, clumsy, and nearly impossible task.

“Website accessibility” is a term used to describe the functionality of a website by individuals with disabilities that may or may not use assistive technology to operate the website.  The issue of website accessibility has become a growing concern for educational agencies as the use of computers and the internet becomes a bigger part of education programs and an important tool for distributing notices and information to stakeholders.

Recognizing that many school websites contain barriers to access for individuals with disabilities, the U.S. Department of Education Office for Civil Rights (OCR) has recently targeted local and state education agencies and schools for investigation and enforcement on the issue of website accessibility.  Government standards for accessibility are in the works, but in the meantime OCR has adopted a set of generally accepted guidelines governing accessibility called the “web content accessibility guidelines” (WCAG).  WCAG is based on 4 principles:

  1. The website must be perceivable (i.e. provide text alternatives for images, provide captions for multimedia, present content in different ways, make it easy to see and hear content, contrast alternatives)
  2. The website must be operable (i.e. make all functionality available through a keyboard, help users navigate content, adequate time to perceive content)
  3. The website must be understandable (i.e. text is readable, content operates in a predictable way, user can correct and avoid mistakes)
  4. The website must be robust (i.e. website is compatible with assistive technology tools)

OCR’s authority for investigating website accessibility complaints derives from its jurisdiction to enforce Section 504 of the Rehabilitation Act (applicable to federal funding recipients) and Title II of the Americans with Disabilities Act (applicable to state and local governments). Generally, these disability discrimination laws require that school districts provide qualified individuals with disabilities equal access to their programs, services, and activities, unless doing so would constitute an undue burden or fundamentally alter the nature of their program.  Even further, Title II of the ADA specifically requires that communications to individuals with disabilities be as effective as communications to individuals who are not disabled.[1]  OCR has read the disability discrimination laws to encompass access to a school district’s website. Maintaining websites that contain barriers to access for individuals with disabilities may violate these laws and open a district/school up to an OCR complaint, investigation, and enforcement.

Best practice for school systems dealing with a variety of stakeholders and community members is to ensure that the school system’s website is accessible to individuals with disabilities before you receive a complaint from OCR.  However, even if you have already received an OCR complaint, there are a number of steps a school system can take to address the issue.

Since website accessibility involves both technical, legal, and administrative components, it is best to approach the problem as a team.  The team should include your district’s information technology staff, legal counsel, third-party website host (if applicable), administrative officers, and anyone else who may contribute or edit content for the district’s website.  As a team, it is important to identify problems, develop a plan for fixing any problems identified, and prepare the district/school for ongoing compliance by developing policies and procedures governing website accessibility and training those involved in developing content and maintaining the district’s website.  The district/school may also want to consider soliciting input from parents, students, community members, and other stakeholders regarding website accessibility.

Undoubtedly, school district and school websites along with other web-based school resources will continue to play an important role for all educational stakeholders.  With that in mind, website accessibility will continue to be a vital concern.

If you have any questions about your website’s accessibility or have received an OCR complaint regarding website accessibility, feel free to contact the Education Law attorneys at PK Law.  They can assist with guiding you on the steps to take to ensure compliance or provide representation with respect to an OCR complaint.

[1] Providing effective communications to individuals with disabilities is also a requirement of Title III of the ADA, which is applicable to public accommodations and commercial facilities.  This may be the next area of concern for website accessibility.

Adam E. Konstas is an Attorney in PK Law’s Education and Labor Group.  He represents local school boards, superintendents, private schools, colleges, and private sector employers before federal and state courts, and federal and state civil rights agencies on a variety of matters, including employment discrimination litigation, teacher and student discipline, collective bargaining, and sexual harassment. Mr. Konstas also advises schools on the design and implementation of policies and procedures regarding student and employee relations, and system-wide policy issues including the use of online instructional tools and cloud computing, student data privacy, anti-discrimination, and website accessibility.

Mr. Konstas is an adjunct professor of school law at McDaniel College, where he completed a class on “Best Practices for Online Teaching and Learning” and is currently teaching an online school law class. He has also lectured on employment law at the University of Baltimore School of Law.  Mr. Konstas can be reached at 410-339-5786 or akonstas@pklaw.com.