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Health Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

Texas Medical Board Proposes New Rules on Heals of Relaxed Telemedicine Laws

by Baker Ober Health Law on

The Texas Medical Board recently proposed changes to its telemedicine regulations (22 Tex. Admin. Code §§ 174.1 – 174.12) to follow the amendments to Section 111 of the Texas Occupations Code governing the practice of...more

Reaping the Jurisdictional Whirlwind

by Reed Smith on

Literally for decades plaintiffs in mass torts have employed the business model of flooding jurisdictions seen as friendly to them with more solicited plaintiffs than any court system can possibly handle. They have employed...more

The Opioid Crisis: Declaring a National Emergency and the Effect on Remote Prescribing through Telemedicine

by McDermott Will & Emery on

On July 31, 2017, President Donald Trump’s Commission on Combating Drug Addiction and the Opioid Crisis recommended that he declare the opioid epidemic a national emergency. In August 2017 and again on October 16, 2017, the...more

AGG Food and Drug Newsletter - October 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Republican Frank White Announces Bid for Florida Attorney General- Republican state Representative Frank White announced his candidacy in the open 2018 race for Florida AG. He is also the general counsel...more

FDA Approves Companion Dx for PD-1 Inhibitor

by Foley & Lardner LLP on

According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung...more

Building a Health App? Part 5: Contracting for Health App Construction

As you take your health app from innovative idea to reality, you will be engaging in a development project that will likely entail the procurement of technology, services and perhaps even content from third parties. For...more

PTAB Declines Request to Review Method of Treating Lymphoma Claim

A Patent Trial and Appeal Board (PTAB) panel declined to institute an inter partes review (IPR) of a claim directed to a method for treating low grade B-cell non-Hodgkin’s lymphoma. The challenged method required patients to...more

Understanding FDA Guidance On Connected Medical Devices

by Morrison & Foerster LLP on

In the coming years, we expect to see an explosion in the number of interoperable medical devices. These are connected medical devices that have the ability to connect to different technologies and devices, even from other...more

Pro Te: Solutio - Vol. 10 No. 3 – Summer 2017

by Butler Snow LLP on

Every summer vacation (or, at least, the ability to take the weekend off!) should include a good read. Whether your preference runs toward a memoir with words of wisdom, a review of new technical advancements, issues of...more

Compulsory Licensing of Biopharmaceutical Inventions

Very few topics in international intellectual property have been as controversial as compulsory licenses. While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets minimum standards for...more

Uncle Sam should be wary in partnering with Big Pharma on cancer treatments

Is Uncle Sam launching a way to speed and improve cancer treatments so they get to patients sooner—or is Big Pharma about to fleece taxpayers, yet again? The National Institutes of Health should carefully consider its just...more

WORD OF THE DAY® – Biosimilar Product

by Latham & Watkins LLP on

Partner Michael Morin explains the term Biosimilar Product from the Book of Jargon® – Healthcare & Life Sciences. The Book of Jargon® – Healthcare & Life Sciences is one of a series of practice area and industry-specific...more

JAMA: Cybersecurity Concerns and Medical Devices – Lessons from a Pacemaker Advisory

Interesting viewpoints from this Journal of the American Medical Association article on FDA’s August 2017 notice re: cyber security issues with certain pacemakers, including:... ...more

H.R. 3985 Calls For Public-Private Working Group to Study Medical Device Security

by Kelley Drye & Warren LLP on

The “Internet of Medical Things Resiliency Partnership Act of 2017” was introduced in the House of Representative earlier this month. Co-sponsored by Rep. David Trott (R-MI) and Rep. Susan Brooks (R-IN), the bill would...more

Seventh Circuit Curtails RICO Application to Third-Party Payor Off-Label Suits

by Reed Smith on

If you want to insult and annoy someone, consider suing them under the Racketeering Influenced and Corrupt Organizations Act, 18 U.S.C. section 1964. That law is charmingly known as RICO, in an allusion to the big bad in the...more

Cybersecurity 2018 – The Year in Preview: HIPAA Compliance

Like many things in Washington, the HIPAA landscape in 2018 will be shaped by the shifting priorities of President Trump’s new administration. Early signs point to less funding for the Office of Civil Rights (“OCR”) within...more

Alert: China Issues New Policy for Drug and Medical Device Approvals

by Cooley LLP on

On October 8, 2017, the General Office of the CPC Central Committee and the General Office of China's State Council jointly issued Opinions of the State Council on Promulgating the Reform of Review and Approval System for...more

Is it HIPAA or HIPPA? Either way, it still applies.

by Winstead PC on

I have negotiated hundreds of SaaS agreements for dozens of software companies and I always hated when the company on the other side was a healthcare provider. Invariably, they would bring up Protected Health Information...more

Get your Single IRB lined up for Multi-Site Research

by Akerman LLP - Health Law Rx on

Changes to the federal regulations governing the protection of human subjects participating in research (known as the Common Rule) were amended earlier this year. The changes to the Common Rule impact research conducted,...more

ACA’s Nondiscrimination Taglines and Notices Require Updating Your Notice of Privacy Practices

by Davis Wright Tremaine LLP on

There has been confusion as to whether the Affordable Care Act’s nondiscrimination provision (“ACA”) affects a covered entity’s notice of privacy practices (“NPP”) or data breach notifications. OCR has issued guidance...more

U.S. watchdogs tally $1.5 billion cost for one type of defective medical device

Big medical device makers, like Big Pharma, have complained Big medical device makers, like Big Pharma, have complained relentlessly that Uncle Sam hamstrings them with red tape and bureaucracy that slows or prevents...more

California Enacts Bill on Drug Pricing Transparency

by Ropes & Gray LLP on

On October 9, 2017, California Governor Jerry Brown (D) signed into law what may be the most comprehensive prescription drug pricing transparency bill in the country. The bill, SB-17, is intended to foster transparency in...more

Vermont AG Settles with SAManage for $264,000 for Delayed Breach Notification

The Vermont Attorney General (AG) recently announced that it has settled with SAManage USA, a business support services company, for failing to timely notify 660 Vermont residents that their names and Social Security numbers...more

New California Law Limits Drug Manufacturer Co-Pay Cards and Other Discounts in California

by Hogan Lovells on

In the most recent salvo by states eager to show an effort to contain prescription drug costs, California's governor has signed into law a bill that will prohibit, with some limited exceptions, pharmaceutical manufacturers...more

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