Tag: patients

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Healthcare

Eagle Pharmaceuticals to discuss second quarter 2020 financial results on August 10, 2020

WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Eagle Pharmaceuticals, Inc. (“Eagle” or the “Company”) (Nasdaq: EGRX) today announced that the Company will release its 2020 second quarter financial results on Monday, August 10, 2020, before the market opens.

Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a conference call to discuss the results as follows:

Date

Monday, August 10, 2020

Time

8:30 a.m. ET

Toll free (U.S.)

877-876-9173

International

785-424-1667

Webcast (live and replay)

www.eagleus.com, under the “Investor Relations” section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-4014 (US) or 402-220-2983 (International) and entering conference call ID EGRXQ220. The webcast will be archived for 30 days at the aforementioned URL.

About Eagle Pharmaceuticals, Inc.

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include RYANODEX®, BENDEKA®, BELRAPZO®, and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle’s website at www.eagleus.com.

Contacts

Investor Relations for Eagle Pharmaceuticals, Inc:
Lisa M. Wilson

T: 212-452-2793

E: lwilson@insitecony.com

Public Relations for Eagle Pharmaceuticals, Inc.:
Faith Pomeroy-Ward

T: 817-807-8044

E: faith@fpwservices.com

Categories
Healthcare

Teva announces new strategic focus in the Japanese market

  • Japan Business Venture shifts focus to specialty assets and a portfolio of select generics that meet patients’ medical needs
  • Remains positioned to address unmet patient needs in core therapeutic areas
  • Will divest majority of current non-differentiated generics portfolio, as well as local manufacturing
  • Business venture remains committed to serving its Japanese patients and healthcare professionals

TEL AVIV, Israel–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), who holds (through its Japanese affiliates) with Takeda a joint business venture (the “BV”) in the Japanese market, announced today a new strategy for its local commercial operations. Nearly five years since its inception, and following an in-depth review of market opportunities, the BV’s new strategy will focus on commercializing a selection of complex generics, specialty assets and other pipeline opportunities.

This shift will include a divestment of the majority of the BV’s generic and operational assets to Nichi-Iko Pharmaceutical Co., Ltd. This transaction is expected to close by early 2021.

The BV will retain approximately 20 generic molecules and several pipeline assets, as well as its robust portfolio of authorized generics, LLPs and specialty assets. The BV will seek to address unmet patient needs with products from its portfolio and pipeline and will continue to combine Teva’s deep marketing expertise, commercial and medical excellence, coupled with financial rigor, with Takeda’s leading brand reputation and strong distribution presence in Japan.

Gianfranco Nazzi, Executive Vice President, International Markets Commercial, said: “The Teva and Takeda business venture has always aimed to address the wide-ranging needs of patients and healthcare professionals in Japan. Our new strategy will allow each of the parties to leverage its core strengths, and ultimately better serve the Japanese patients. For Teva, and in line with the company’s strategic objectives, the new model presents a chance to drive better performance by focusing our Japan business on a portfolio of select generics and pipeline of specialty assets, while continuing to put patients and healthcare professionals at the center of our strategy.”

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 re: our new strategic focus in the Japanese market, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

  • the potential that the expected benefits and opportunities related to our new strategic focus may not be realized or may take longer to realize than expected;
  • risks related to the satisfaction of the conditions to closing the disposition of certain of our joint venture’s generic and operational assets (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including the possibility that the disposition does not close, and the companies’ ability to consummate the disposition on the terms agreed by the parties;
  • our ability to successfully compete in the marketplace, including: competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations and the effectiveness of our patents and other measures to protect our intellectual property rights;
  • our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
  • our business and operations in general, including: duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; interruptions in our supply chain, including due to potential effects of the COVID-19 pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our customers and suppliers; adequacy of and our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; implementation of our restructuring plan announced in December 2017; challenges associated with conducting business globally, including adverse effects of the COVID-19 pandemic, political or economic instability, major hostilities or terrorism; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption sanctions and trade control laws; manufacturing or quality control problems; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; our prospects and opportunities for growth if we sell assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
  • compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject or delays in governmental processing time including due to modified government operations due to the COVID-19 pandemic and effects on product and patent approvals; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
  • other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;

and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2020 and our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

Contacts

IR Contacts

United States

Kevin C. Mannix (215) 591-8912

Israel
Ran Meir 972 (3) 926-7516

PR Contacts

United States
Doris Li (973) 265-3752

Israel

Yonatan Beker

972 (54) 888 5898

Categories
Healthcare

Bristol Myers Squibb and bluebird bio announce submission of Biologics License Application (BLA) to FDA for Idecabtagene Vicleucel (Ide-cel, bb2121) for adults with relapsed and refractory multiple myeloma

BLA submission based on results from pivotal Phase 2 KarMMa study evaluating ide-cel in heavily pre-treated patient population

Companies are committed to working with the FDA to rapidly advance ide-cel through the regulatory review process

PRINCETON, N.J., & CAMBRIDGE, Mass.–(BUSINESS WIRE)–$BLUE #BMS—Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma. This submission provides further details on the Chemistry, Manufacturing and Controls (CMC) module to address the outstanding regulatory requests from the FDA in May 2020 following the original BLA submission from March 2020.

The submission is based on results from the pivotal Phase 2 KarMMa study evaluating the efficacy and safety of ide-cel in relapsed and refractory multiple myeloma patients exposed to an immunomodulatory (IMiD) agent, a proteasome inhibitor (PI) and an anti-CD38 antibody. Results from the study were shared during an oral presentation as part of the American Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program.1

Multiple myeloma is a cancer of plasma cells.2 The cause of multiple myeloma is not known and currently there is no cure; however, there are a number of treatment options available that can lead to response.2 Patients who have already been treated with some available therapies but continue to have progression of their disease have “relapsed” and “refractory” multiple myeloma, meaning their cancer has returned after they have received initial treatments. Patients with relapsed and refractory multiple myeloma that have been exposed to all three major drug classes, including an IMiD agent, a PI and an anti-CD38 antibody, have fewer treatment options and poor outcomes, including shorter response durations and lower overall survival.3

Ide-cel was granted Breakthrough Therapy Designation (BTD) by the FDA, and PRIority MEdicines (PRIME) designation and validation of its Marketing Authorization Application (MAA) by the European Medicines Agency for relapsed and refractory multiple myeloma.

Ide-cel is not approved for any indication in any geography.

For Holders of Contingent Value Rights (CVR), Ticker BMY-RT

U.S. FDA approval of ide-cel by March 31, 2021 is one of the required remaining milestones of the Contingent Value Rights issued upon the close of the Celgene acquisition in the fourth quarter of 2019. The other is U.S. FDA approval of liso-cel by December 31, 2020. The company is committed to working with FDA to progress both applications and achieve the remaining regulatory milestones required by the CVR.

About Ide-cel

Ide-cel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy. The ide-cel CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing BCMA, attached to a human CD8 α hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 4-1BB and CD3-ζ chain, in tandem. Ide-cel recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

Ide-cel is being developed as part of a Co-Development, Co-Promotion and Profit Share Agreement between Bristol Myers Squibb and bluebird bio. Ide-cel was granted accelerated assessment by the European Medicines Agency (EMA) on March 26, 2020, and the MAA was validated by the EMA on May 20, 2020.

About KarMMa

KarMMa (NCT03361748) is a pivotal, open-label, single-arm, multicenter, multinational, Phase 2 study evaluating the efficacy and safety of ide-cel in adults with relapsed and refractory multiple myeloma in North America and Europe. The primary endpoint of the study is overall response rate as assessed by an independent review committee (IRC) according to the International Myeloma Working Group (IMWG) criteria. Complete response rate is a key secondary endpoint. Other efficacy endpoints include time to response, duration of response, progression-free survival, overall survival, minimal residual disease evaluated by Next-Generation Sequencing (NGS) assay and safety. The study enrolled 140 patients, of whom 128 received ide-cel across the target dose levels of 150-450 x 106 CAR+ T cells after receiving lymphodepleting chemotherapy. All enrolled patients had received at least three prior treatment regimens, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and were refractory to their last regimen, defined as progression during or within 60 days of their last therapy.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

About bluebird bio, Inc.

bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, we’re developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, we’re working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. We’re putting our care and expertise to work across a spectrum of disorders including cerebral adrenoleukodystrophy, sickle cell disease, β-thalassemia and multiple myeloma using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

bluebird bio is a trademark of bluebird bio, Inc.

Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results will be consistent with the results to date, that ide-cel, or bb2121, may not achieve its primary study endpoint or receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

bluebird bio Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of ide-cel. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, the possibility that the BLA submission may not be accepted for filing by the FDA without the provision of further information or responses to additional requests, if at all, that ide-cel may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all, and, if approved, whether ide-cel will be commercially successful, that the positive results for ide-cel may not continue in additional clinical trials, and that the collaboration with Bristol Myers Squibb may not continue or be successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect bluebird bio’s business, particularly those identified in the risk factors discussion in bluebird bio’s Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, bluebird bio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

Hyperlinks are provided as a convenience and for informational purposes only. Neither Bristol Myers Squibb nor bluebird bio bears responsibility for the security or content of external websites or websites outside of their respective control.

References

  1. Munshi NC, et al. Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM): initial KarMMa results. ASCO 2020 Virtual Scientific Program. Abstract #8503.
  2. American Cancer Society. What is Multiple Myeloma? Available at: https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed June 2020.
  3. Jagannath S, et al. KarMMa-RW: a study of real world treatment patterns in heavily pretreated patients with relapsed and refractory multiple myeloma (RRMM) and comparison of outcomes to KarMMa. ASCO 2020 Virtual Scientific Program. Abstract #8525.

Contacts

Bristol Myers Squibb
Media Inquiries:

609-252-3345

media@bms.com

Rose Weldon

rose.weldon@bms.com

Investors:

Tim Power

609-252-7509

timothy.power@bms.com

bluebird bio

Media:
Victoria von Rinteln

617-914-8774

vvonrinteln@bluebirdbio.com

Investors:
Ingrid Goldberg

410-960-5022

igoldberg@bluebirdbio.com

Elizabeth Pingpank

617-914-8736

epingpank@bluebirdbio.com

Categories
Healthcare

Bayer continues to earn top marks in 2020 Disability Equality Index

Company earns score of 90 and recognized as a Best Place to Work for Disability Inclusion

WHIPPANY, N.J.–(BUSINESS WIRE)–For the second consecutive year, Bayer U.S. was recognized as a Best Place to Work for Disability Inclusion, earning a score of 90 in the 2020 Disability Equality Index (DEI). Bayer’s DEI score improved from 2019, recognizing the company’s continued growth. DEI is the most comprehensive disability inclusion assessment tool designed and embraced by both business leaders and disability advocates across the United States.

“Improving our policies and benefits for employees with disabilities has always been a priority for us,” said Philip Blake, President of Bayer U.S. “Increasing our score and being recognized as one of the best places to work for disability inclusion is a true honor and testament to Bayer’s commitment to bettering the lives of its employees and their families.”

Bayer is committed to sustaining an inclusive culture with a diverse workforce, which represents the communities it serves. As part of this commitment, the company partnered with Inclusion Works of Disability:IN, the leading nonprofit resource for business disability inclusion worldwide. In addition, the U.S. Bayer Diversity Advisory Inclusion Council (BDAIC) and Business Resource Groups (BRGs) are critical aspects of Bayer’s Inclusion and Diversity (I&D) strategy. ENABLE, one of Bayer’s Resource Groups, is dedicated to the overall wellness and development of employees and their families with disabilities.

“Aligned with our inclusive vision of Health for All and Hunger for None, we embrace and encourage our employees’ uniqueness and continue to work to build a culture where every employee feels a sense of belonging,” said Shakti Harris, Head of Bayer’s Inclusion & Diversity in the U.S. “This DEI recognition represents the hard work, passion, and commitment everyone at Bayer has given to get to this point. Not only is disability inclusion the right thing to do, but it’s naturally aligned with the communities and patients we serve.”

Created six years ago, the DEI guides businesses to impact the unemployment and underemployment of people with disabilities. This year the DEI evaluated inclusion criteria for culture and leadership, enterprise-wide access, employment practices, such as benefits, employment, education and accommodations, in addition to community engagement, and supplier diversity.

“The best way to attract, retain and grow talent with disabilities is to create an accessible, inclusive workplace. This year’s top scoring Disability Equality Index companies are demonstrating their commitment to many of the numerous leading disability inclusion practices featured in the DEI, recognizing that there’s still room for improvement,” said Jill Houghton, President and Chief Executive Officer of Disability:IN. “We are proud to have developed strong partnerships with corporate allies who are committed to advancing disability inclusion and equality across their businesses in the United States and around the world.”

In 2020, 247 corporations, including 143 Fortune 500 and 154 Fortune 1000 utilized the Disability Equality Index (DEI) to benchmark their disability inclusion efforts. Companies that scored an 80% or higher were recognized as a “Best Place to Work for Disability Inclusion.”

For more information on the 2020 Disability Equality Index, visit https://disabilityin.org.

About Disability:IN®

Disability:IN, formerly known as the US Business Leadership Network, is the leading nonprofit resource for business disability inclusion worldwide. Partnering with more than 220 corporations, Disability:IN expands opportunities for people with disabilities across enterprises. The organization and 30 affiliates raise a collective voice of positive change for people with disabilities in business. Through its programs and services, Disability:IN empowers businesses to achieve disability inclusion and equality, with the goal of advancing inclusion to the point when the organization is no longer necessary. Learn more at: www.disabilityin.org.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.us.

Bayer® and the Bayer Cross® are registered trademarks of Bayer.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contacts

Carolyn Nagle

Bayer U.S.

Email: carolyn.nagle@bayer.com
Mobile: 201-419-0337

Social Media Channels
– Facebook: BayerUnitedStates
– Twitter: BayerUS
– Instagram: BayerUS
– YouTube: BayerUS

Categories
Local News

Violation of HIPAA’s privacy laws could mean prison time

Photo by Michelle Dryden
Stephen Miller is chief compliance officer at Capital Health System Regional Medical Center in Trenton.

TRENTON, N.J. — Nowadays, invasion of one’s privacy is more accessible given the growth of social media and electronic devices everywhere; and this means greater protection for personal information.

Hackers and identity thieves are inquisitive about the sources to personal information that they can find. Employees working at healthcare facilities are also held accountable for protecting the privacy of patients they care for. Patients’ privacy is protected by the Health Insurance Portability and Accountability Act, (HIPAA), that was “born out of a statute in 1996,” said Stephen Miller, chief compliance officer at Capital Health System Regional Medical Center.

Miller said this Act covers several regulations, but only one part of it covers privacy information about patients.  Congress directed The Department of Health and Human Services to create the HIPAA laws. It was a broad piece of legislature that covered various regulations. One part of it had to do with disclosure and privacy, said Miller.

The HIPAA has a set of rules about privacy that, “tell healthcare providers how they can use information about their patients and with whom and under what circumstances they can share information about patients,” he said.

Miller explained that this law created at “floor”. “It created a floor–single set of rules that no matter where you go in the county you know if you see a healthcare provider: if go to a doctor, you go to a hospital, if you go to a nursing facility or a physical therapist, and give them information about yourself, you know there are certain things they are allowed to do with that information. There are certain things they are not allowed to do with that information. And there are certain ways they have to protect that information,” he said.

The reason we call that a floor because the law says you must at least follow these rules. States can pass their own laws and they can make them more protective of patients, but you have to at the minimum follow those rules nationally, Miller continued. “It created best-practice in a way for protecting information about patient,” he said.

Often times, when the HIPAA rules are broken, it has to do with identity theft, said Miller. He told of an incident, where employees were hacking into computers and stealing the identity of their cancer patients who were terminally ill. They wanted to get credit cards in their names.

However, breaching HIPAA privacy laws was not a prison term violation until recently.  Huping Zhou, “former University of California at Los Angeles [UCLA], Healthcare System research assistant, was sentenced to four months in prison after admitting he illegally read private electronic medical records of celebrities and others,” writes Howard Anderson of The Security Scrutinizer.

As Miller points out, it is easier for hackers; HIPAA violators and other identity thieves to leave a building with laptop under their jacket or a thumb drive in their pockets. Some individuals are even using cell phones to invade the privacy of others, by taking photos or recording conversations. Therefore, we need greater protections for information on these electronic devices.