Legal Workspace has produced  free online test to help corporate executives and counsel determine whether their firms are in compliance with the Health Insurance Portability and Accountability Act.

The click-through quiz includes topics such as encryption for all email, two-factor authentication for access to computer systems housing healthcare data, business associate agreements with all vendors, intrusion detection systems, electronic protected health information, HIPAA guidelines for off-site data backup providers, and more.

Take the quiz.

Pharmaceutical and medical device companies find themselves in the crosshairs for major matter “bet-the-farm” litigation, and recent research tends to suggest that such large-scale litigation is going to increase, reports litigation consulting firm DOAR in a new article published on its website.

DOAR is offering a presentation of its research and findings to corporate legal departments and the lawyers who represent them. The research is based on a national survey of attitudes toward the pharmaceutical industry that reports on consumer and juror sentiments and the ways in which their views and dispositions may impact litigation strategies.

“In order to best advise our clients as they respond to this shifting landscape, DOAR conducted empirical research designed to identify the key factors that contribute to jurors’ perceptions of product liability and defending companies, and how juror attitudes can be altered,” the company said. “What may be surprising is the vigor and specificity in feedback offered by individuals – as customers and as prospective jurors.”

Read the article.

The Los Angeles Times examines the question of whether actor Charlie Sheen faces legal jeopardy if he did not disclose to sex partners that he was HIV-positive. He announced on Tuesday that he tested positive for HIV four years ago.

Los Angeles police told The Times that they have received no complaints against the actor.

“In California, it is against the law for a person to willfully expose others to the human immunodeficiency virus. The crime is punishable by up to eight years in prison,” the paper reports.

Few cases of this type go to trial, but it has happened, according to the report.

Read the article.

Fitch, Even, Tabin & Flannery LLP will hold a complimentary webinar, “Navigating Patent Potholes Along the FDA’s Proposed ANDA / 505(b)(2) Pathway,” presented by Kendrew Colton and James Zak. The webinar will be Wednesday, Dec. 2, 2015, at 9 am PST / 10 am MST / 11 am CST / 12 noon EST.

The FDA has released new rules regarding the procedures for approval of ANDA and 505(b)(2) applications implementing the Medicare Prescription Drug, Improvement, and Modernization Act (MMA). The U.S. Patent and Trademark Office in turn has created new procedures and other ways by which they cancel, modify, and administer patent rights. The USPTO’s actions have created potholes along the FDA-proposed pathways for pharmaceuticals companies and generics manufacturers attempting to maintain monopolies. Their activities may also provide an express lane for new startups in the pharmaceutical space.

The webinar will cover these topics and more:
• Newly listed patents in the Orange Book and the ability to catch up to first applicants
• Breaking through settlement roadblocks with AIA post-grant procedures
• Newly listed and issued patents downshifting ANDAs into tentative approvals
• Express lane for 505(b)(2) applicants

The speakers will be Fitch Even attorneys Kendrew H. Colton and James A. Zak. Colton has extensive IP counseling and litigation experience, with a focus on designing strategies to achieve market exclusivity and freedom to operate for clients working with chemical and biochemical technologies. Zak chiefly focuses his practice on the intersection of intellectual property and FDA law, often working with startups in FDA-regulated industries to develop and align their IP and FDA market approval strategies while simultaneously developing robust patent portfolios.

CLE credit has been approved for California and Illinois and is pending in Nebraska. Other states may also award CLE credit upon attendee request. There is no fee to attend, but please note registration is required.

Following the live event, a recording of the webinar will be available to view for one year at fitcheven.com.

Register for the webinar.

Employers generally embrace a policy of utilizing at-will employment as often as possible, where employers and employees can end their relationship with each other at any time and for any (legal) reason, writes F. Kytle Frye III of Fisher & Phillips LLP in an article posted on JDSupra.com. Written employment contracts are usually reserved for select executives and a few professionals.

“Numerous states, often through judicial pronouncements, have recognized varying exceptions to the at-will employment concept, such as allowing employees to challenge their termination as a violation of public policy,” he writes.

“The 8th Circuit Court of Appeals recently published a decision which sharply limits the application of the public policy exception. Interestingly, this limitation does not apply to at-will employees, but to employees with employment contracts. Somewhat ominously, the decision does not extend to all such contracts, creating an air of uncertainty for any healthcare business with employment contractual situations.”

Read the article.

Clearwater Compliance will present a complimentary webinar featuring industry experts discussing how to assess specific security risks and build a strong business case for enhanced security.

The webinar, titled “How to Calculate the Cost of a Data Breach and How to Get the Budget for Your HIPAA-HITECH Compliance Program,” will be Dec. 3, 2015, from 11 a.m. to 12:15 Central time.

“Even with the increased enforcement of HIPAA and HITECH requirements and the increase in penalties being levied for non-compliance, the security efforts of health care organizations responsible for safeguarding protected health information (PHI) are simply not keeping pace with the growing risks of unauthorized or impermissible disclosures of PHI,” the company says on its website. “Those risks are increasing as a result of the expansion in the number of organizations handling PHI and thus statutorily-obligated to comply with HIPAA, the increase in electronic health record (EHR) adoption and the growing rewards of PHI theft.”

Register for the webinar.

California-based Kite Pharma, Inc. (Kite) has entered into a worldwide research and license agreement with Washington-based Alpine Immune Sciences, Inc. (AIS), a privately‐held biotechnology company, to discover and develop protein‐based immunotherapies targeting the immune synapse to treat cancer.

In a release, the company said AIS will grant Kite an exclusive license to two programs from its transmembrane immunomodulatory protein (TIP™) technology, which Kite plans to further engineer into chimeric antigen receptor (CAR) and T cell receptor (TCR) product candidates. Under the terms of the collaboration, Kite will make an upfront payment to AIS of $5 million and additional payments to support AIS’ research. AIS will be eligible to receive milestone payments based upon the successful achievement of pre‐specified research, clinical, and regulatory milestones totaling $530 million plus low single digit royalty payments on product sales.

Latham & Watkins LLP counsel Geoff Kuziemko, based in the firm’s Silicon Valley office, represented Alpine Immune Sciences in the licensing agreement. Silicon Valley partners Patrick Pohlen and Brian Cuneo advise AIS on corporate matters.

The release continues:

“The field of immuno‐oncology has the potential to significantly improve the outcome of patients with cancer,” said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer of Kite. “We believe the ability of AIS’ TIP™ technology to modulate the immune synapse can be incorporated into engineered T cell therapies to advance CAR and TCR product candidates into multiple tumor types. This collaboration is another example of Kite’s continuing commitment to advancing our pipeline through transformative technologies grounded in innovative science.”

Under the terms of the collaboration, Kite will make an upfront payment to AIS of $5 million and additional payments to support AIS’ research. AIS will be eligible to receive milestone payments based upon the successful achievement of pre‐specified research, clinical, and regulatory milestones totaling $530 million plus low singledigit royalty payments on product sales. Kite will receive an exclusive, worldwide license to research, develop and commercialize engineered autologous T cell therapies incorporating two programs coming from the AIS platform.

“AIS was established with a team of experienced scientists to capitalize on our keen understanding of immunology and protein engineering,” said Mitchell H. Gold, M.D., Executive Chairman. “At AIS, we have a robust discovery platform to identify molecules capable of directly modulating the immune synapse. We look forward to working with Kite, a company that uniquely understands the complexities surrounding cancer biology.”

About Kite Pharma, Inc.

Kite Pharma, Inc., is a clinical‐stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on engineered autologous cell therapy (eACT™) designed to restore the immune system’s ability to recognize and eradicate tumors. Kite is based in Santa Monica, CA.

About Alpine Immune Sciences, Inc.

Alpine Immune Sciences, Inc. is a privately‐held biotechnology company focused on developing protein‐based immunotherapies that harness the body’s own immune system to target cancer and autoimmune disease. AIS has developed a proprietary variant immunoglobulin domain (vIgD™) platform to enhance or diminish an immune response. The vIgD™ platform, unlike other therapeutic approaches in development or available commercially that address a single target, is designed to interact with multiple targets in the immune synapse. AIS has also developed a transmembrane immunomodulatory protein (TIP™) technology, based on the vIgD™ platform, for direct applications with engineered T cell therapies to potentially improve their efficacy and persistence. AIS was launched in 2015 with series seed financing from Alpine BioVentures and is headquartered in Seattle, WA. Alpine BioVentures is a Seattle‐based healthcare venture firm led by Dr. Mitchell H. Gold, Managing Partner, a long‐time executive and pioneer in the immuno‐oncology area, and Jay Venkatesan, Managing Partner, a veteran investor in the biotechnology space.

Kite Pharma, Inc. Forward‐Looking Statements This press release contains forward‐looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward‐looking statements. Forward‐looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to research and develop TIP™ technology and to engineer a TIP™ into CAR and TCR product candidates; the success of such product candidates and their ability to overcome the inhibitory mechanisms present in the tumor microenvironment; and the ability to advance Kite’s pipeline through new technologies. Various factors may cause differences between Kite’s expectations and actual results as discussed in greater detail in Kite’s filings with the Securities and Exchange Commission, including without limitation in its Form 10‐Q for the quarter ended June 30, 2015. Any forward‐looking statements that is made in this press release speak only as of the date of this press release. Kite assumes no obligation to update the forward‐looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Gritstone Oncology, a cancer immunotherapy company developing next-generation, personalized cancer therapeutics, has announced a Series A financing of $102 million. The financing will support discovery and development of novel tumor-specific neo-antigen (TSNA) based immunotherapies, with an initial focus on lung cancer, the company said in a release.

Latham & Watkins LLP advised Gritstone Oncology in its formation and the Series A financing with a corporate team led from the firm’s Silicon Valley office by partners Alan Mendelson and Brian Cuneo, with associates Alexander White and Kevin Tsai.

The financing was co-led by biotechnology investors Versant Ventures and The Column Group, with Clarus Ventures alongside. Other investors include Frazier Healthcare Partners, Redmile Group, Casdin Capital, and Transformational Healthcare Opportunity, a special-purpose vehicle for private investors.

“We are honored that this discerning group of investors recognized the tremendous potential that exists both in our approach and our team,” said Andrew Allen, M.D., Ph.D., Gritstone Oncology co-founder, president and CEO. “We believe that this substantial funding, along with our best-in-class expertise, a systematic discovery and development approach, and our commitment to do the scientific heavy-lifting required, will enable us to solve the core challenge of identifying personalized, therapeutic neo-antigens for individual patients.

“Cancer immunotherapy is an exciting area of discovery, and an ability to predict the antigens recognized by T cells that drive tumor elimination is likely fundamental to continuing advances in the field,” said Allen. Gritstone will focus initially on discovering and developing TSNA-based therapies for non-small cell lung cancer (NSCLC).

Compliancy Group will present a complimentary webinar Thursday, Oct. 22, 2-3:30 p.m. EDT, to discuss how a medical practice can measure, control and protect the practice’s reputation.

“Can you name the one thing in your practice that can dictate everything from new patient referrals to insurance contract negotiations and recruiting of staff and providers?” the firm asks.

“Your practice’s online reputation is your most important asset, yet it is often ignored, unmanaged or neglected.”

David Brooks, VP, Marketing, Doctor.com, will discuss:

• How patients, insurance carriers, and potential employees evaluate the reputation of your practice
• Five things you can do right now to improve the way search engines view your practice’s reputation
• The best practices that define high-performance practices

The webinar is limited to medical practice owners and senior practice management executives.

Register for the webinar.

Dire predictions that the Affordable Care Act would lead to job losses and cuts in employee hours have so far proved to be unfounded, according to a new research paper from Federal Reserve Bank of New York economist Maxim Pinkovskiy and reported on the website of CBS Moneywatch.

According to the CBS report, “The fear was that employers who were newly required to provide health insurance to their workers would opt instead to cut hours or fire employees. But early numbers show that locations with a high percentage of uninsured Americans, such as Texas, ended up experiencing a rise in employment, salaries and output in comparison to areas with less exposure to the health care law, Pinkovskiy noted.”

Part-time work in states where Obamacare had major impact saw “a statistically insignificant decline in their part-time to full-time ratio,” Pinkovskiy wrote.

Read the report.

Common law judicial doctrines in almost every state discourage and restrict arbitration agreements covering personal injury or death claims, write Manton G. Grier and Marcus A. Manos of Nexsen Pruet. They see this point particularly regarding admission contracts to nursing homes or assisted-living facilities, which have superior bargaining power and may offer services on a “take it or leave it” basis.  The Federal Arbitration Act (FAA), on the other hand, encourages arbitration of claims.

“Because the arbitration laws stack the deck against a facility, there is no foolproof way to draft an arbitration agreement; what may be found enforceable by one judge may be found unenforceable by another,” they write. “With so many defenses available to plaintiffs, a bullet-proof agreement just doesn’t exist.  Nevertheless, there are five ways a facility can improve the odds that a court will enforce the agreement.”

Read the article.

Johnson & Johnson scored a defense win in a lawsuit over its Prosima pelvic mesh implant Oct. 5, after a Texas state jury ruled that the device was not defectively designed and that J&J subsidiary Ethicon’s risk warnings were adequate, reports Courtroom View Network.

“The jury reached a 10-2 verdict after beginning deliberations on Friday following a two-week trial during which attorneys for plaintiff Carol Cavness argued that J&J’s Ethicon unit knew the Prosima mesh was too stiff and could cause vaginal tissue to degrade, but failed to adequately warn patients and doctors of the risks,” the site reports. “Cavness, who is 60, had the Prosima mesh implanted in 2012 to treat a condition called pelvic organ prolapse, and claimed since then she’s suffered pain, infections and undergone multiple surgeries in an effort to remove the mesh.”

Read the story.

An article on Holland & Hart’s Health Law Blog provides a 40-point checklist that can be used when preparing or reviewing contracts involving the work of physicians.

Kim Stanger, Pia Dean and Bill Mercer wrote the article.

Topics covered include regulatory compliance, written agreement, nature of relationship, services, schedule, location, independence, intellectual property, use of information, outside services, qualifications, representations and warranties, performance standards, medical records, employer obligations, compensation, benefits, exempt status, referrals, assignment of fees, liability insurance, workers compensation insurance, indemnification, terms, termination, post-termination obligations, confidentiality, noncompetition, nonsolicitation, penalties for violation, notice, assignment, governing law and venue, alternative dispute resolution, entire agreement, meaningful use assignment, construction, no third-party beneficiaries, and survival of terms.

Read the article.

A panel of industry experts will discuss key tools to expand your portfolio to include ‘Compliance as a Service’ for your healthcare clients in a webinar aimed at MSP or business associates working with healthcare providers.

The panel will discuss key tools to use in expanding portfolio of offerings to clients. Participants will find out how to differentiate your company, increase revenue and client loyalty.

The webinar will be Thursday, September 24 at 2PM EST.

Speakers include Andy Nieto, (Health IT Strategist at DataMotion), Marc Haskelson (President & CEO of Compliancy Group), Stuart Crawford (Founder & CEO, Ulistic Inc.) and Jon Matero (President/CEO, Network Heroes).

Participants will gain:
Ideas for providing added value to your clients
Ways to simplify compliance
How to help clients protect data at rest, in motion and in use
How to make your Managed Service Provider STRATOSPHERICALLY SUCCESSFUL
Solutions for encryption as a service
Solutions for compliance as a service
The importance of a Culture of Compliance
Best practices to accelerate your business- tried and tested stories from the “trenches”

Register for the webinar.

A program planned by Farrell Fritz will cover trusts and estates, labor and employment, estate litigation and healthcare topics.

The seminar will be Nov. 4, 8 a.m. to 12:15 p.m., at the Long Island Marriott, 101 James Doolittle Blvd., Uniondale, NY 11553

Accountants will receive 4.0 CPE credits (1.0 Taxation; 2.0 Specialized Knowledge & Applications Related to Specialized Industries; 1.0 Advisory Services).

Speakers and topics:

Eric M. Kramer, CPA, Esq., Trusts & Estates Partner | Estate Planning for the Closely-Held Business

Learning Objectives:
– Discuss tax efficient methods of transferring a closely-held business
– Review the non-tax issues encountered among family members

Domenique Camacho Moran, Esq., Labor & Employment Partner | Wage & Hour Issues that Plague Employers

Learning Objectives:
– Summarize Department of Labor’s 2015 Proposed Rules
– Proper classifications of Interns
– Managing Wage & Hour Audits
– Review Recordkeeping Requirements

Eric W. Penzer, Esq., Estate Litigation Partner | Tips to Avoid Estate Litigation

Learning Objectives:
– Recognizing the signs of a will contest
– The effective use of “no contest” clauses
– Special considerations for testators with diminished capacity
– Choosing the right fiduciaries
– Post-death disputes over lifetime gifts
– Joint accounts, convenience accounts & Totten trusts
– Disputes over the “family business”

Jeffrey P. Rust, Esq., Farrell Fritz Healthcare Partner | The Medical Professional: Issues Regarding Ownership, Transition & Regulatory Compliance

Learning Objectives:
– Professional entities under New York Law
– Closure or sale of a medical practice
– Multiple owner professional practices
– The physician landlord and regulatory compliance

RSVP to Carmela Lamberta (clamberta@farrellfritz.com) by 10/21/15 with your complete contact information.

Registered NYS CPE Sponsor ID # 001975

Register for the seminar.

Kane Russell Coleman & Logan has posted an article by Karin Zaner on its blog, The Doctor’s Advocate, discussing 10 tips for physician employment contracts.

The article discusses the importance of reading and understanding the agreement before signing, leverage in terms of employment negotiation, non-compete obligations, non-solicitation and non-ownership obligations, HIPAA, privacy and trade secret confidentiality, income guarantees, logistics, finding a good match, recognizing red flags, and resisting the urge to resign.

Read the article.

A complimentary webinar presented by Davis Wright Tremaine will discuss the negotiation of Health Information Technology (HIT) contracts, identifying tips and traps based on real world experience with contract successes and failures.

The webinar will be Tuesday, August 11, at 10 a.m. Pacific time.

“Frequently the legal contract is the last hurdle to beginning a new HIT project, and, for many health care organizations, the process can be a source of frustration in acquiring new technologies,” the firm says on its website. “This session will focus on best practices for maximizing the effectiveness of contract negotiations for HIT projects. We will examine key legal issues and practical implications arising from the process and the substantive contract terms.”

Register for the webinar.

Compliancy Group will present a complimentary webinar designed to help participants and their clients be compliant with healthcare regulations. The event will be Tuesday, August 18, at 2 p.m. Eastern time.

“According to HHS, 70 percent of the market is not HIPAA compliant, while CMS states that 79 percent of Meaningful Use Audits result in failure.” Compliancy Group says on its website. “The two biggest factors: incomplete risk assessments and the lack of understanding between the difference of HIPAA and HITECH compliance. With massive breaches, like Anthem, and mandatory 5% Meaningful Use Audits, Covered Entities are looking to their MSPs to provide a solution.”

The webinar will cover:

• Be confident about compliance
• Increase profits
• Retain clients
• Acquire new clients

Register for the webinar.

The standards for walkway safety have changed – and the way slip and fall lawsuits are going to change with them, reports The Expert Institute.

The Institute has produced a white paper that outlines crucial updates made by the (ANSI) B101 committee on safety requirements for slip, trip, and fall requirements, and how they will impact defendant liability in more than half of all slip and fall claims.

The information in this whitepaper will help readers:

• Use new testing standards to prove defendant liability
• Select better slip and fall cases
• Understand how these new standards will affect your practice

Download the white paper.

The parents of a community college student who went into a coma and died after a diagnostic test at Phelps Memorial Hospital Center in New York State have reached an $18.1 million settlement with the hospital and doctor who treated their daughter.

A report in lohud.com, a Gannett company, said Raina Ferraro, 19, had an endoscopy, in which a hollow tube is inserted into the body, usually through the mouth, at Phelps in January 2013 after experiencing stomach pain.

During the procedure, the patient went into cardiac and respiratory arrest. She died in May after more than two years in a vegetative state.

Her parents were represented by attorney Sanford Rubenstein.

Read the article.