Regulation has always been a fact of life in the healthcare and pharmaceuticals industries: the Affordable Care Act is just the most recent example. Noncompliance can mean costly penalties and have serious health-related consequences. Complying with new regulatory changes can disrupt what once had been efficient compliance procedures—and turn your bottom line from black to red in the process.

Secure Direct Messaging for Healthcare

Government initiatives and incentives have encouraged the adoption of electronic medical & health records solutions from many vendors. Unfortunately, this multi-vendor environment has created individual islands and closed networks of records that cannot be shared easily and securely between healthcare providers using different solutions. This limits the value of EHR/EMR, particularly when consultation across health networks or transitions of care are required.

Based on the national encryption standard called “Direct Protocol” for securely exchanging clinical healthcare data via the Internet, Healthcare organizations are required to use secure “Direct“ messaging for healthcare providers, patients, business associates, and clinical systems. Using Direct Standards, PHI can be sent and received securely, in a manner that conforms to MU2 guidelines. It supports a variety of sensitive data, including summary of care documents, large images, and personal messages. Best of all it integrates easily with existing EMR/EHR solutions to fully support in-network and out-of-network communications.

The objective is that Health Information Service Providers (HISP), provisioning Direct services that are fully interoperable with other HISPs. When Direct Messaging Systems are entrusted with the delivery of secure messages, documents, and images, that data is processed and stored in a ‘mission critical’ manner following the best practices of strong encryption, checksums, disaster recovery, high availability, and data back-up.

Healthcare providers in all types of organizations are adopting Direct Secure Messaging (Direct) to improve patient care and attest to Meaning Use Stage 2 (MU2) standards. Direct utilizes the familiar structure of email and enhances it with sender and recipient identity validation, message encryption and message delivery notification. Privacy and security are further enhanced through the trust relationship established between Health Information Service Providers (HISPs).

Eligible Hospitals (EHs) and Critical Access Hospitals (CAHs) seeking to meet the transition of care objectives of Meaningful Use Stage 2 (MU2) are encountering serious obstacles to attestation because the technology for delivering summary of care records is not fully deployed. Specifically, the entities to which referrals are typically sent are not equipped with Direct Secure Messaging (Direct) and therefore lack the recipient addresses that are needed to transition referrals from one setting of care to another.

TBS will assist it’s Healthcare clients in setting up Direct Secure Communications to overcome the issue of interoperability among disparate Healthcare Information Exchange systems. TBS’s solutions easily integrate with providers’ email clients, mobile devices, EHR systems, and other healthcare workflows. When utilizing Direct protocol as a hosted service there is no software, hardware, or apps to install. Direct communications could include an optional Community Web Portal feature with a built-in C-CDA viewer that extends Direct addresses to individual providers and enables them to easily read and print the Continuation of Care Documents (CCDs) sent by hospitals. This enables participation with other providers in this important emerging communications network.

TBS will coordinate the implementation of Direct communication with Healthcare organizations of all sizes in our effort to reduce interoperability issues the Industry has been struggling with. We will provide the guidance needed  throughout  the process of needs analysis through the proposal to implementation of the solution.

BUSINESS BENEFITS

• Meaningful Use Stage 2 Attestation: Meet requirements for Transition of Care
• Improve Compliance: Minimize exposure to regulatory violations.
• Cost Containment: Cut costs of faxes, printing, postage, and courier services.
• Seamless External Communication: Easily send and receive PHI with providers and health care systems outside of your primary network.
• Minimize Business Risk: Protect your brand and reputation by preventing data leaks.

Healthcare and Section 508

The 1998 Section 508 Amendment to the 1973 U.S. Workforce Rehabilitation Act mandates that people with disabilities be given equal access to healthcare-related electronic information and data.

TBS’s subject matter experts remediate legacy documents and guarantee new documents’ accessibility and compliance with Section 508.

Using DITA, we add or edit structural tags to define document elements to make documents accessible to assistive technology. We ensure that your documents pass all Adobe Acrobat Section 508 checks without provoking warning or error messages. And our QA ensures that screen readers yield a quality reading experience.

Pharmaceuticals and NDAs

Getting a drug to market means getting U.S. Food and Drug Administration (FDA) approval, which involves assembling and filing the FDA’s required new drug applications (NDAs).

Shareholder value is directly related to the speed with which new drugs can be patented and brought to market—and, therefore, to the speed with which NDAs can be assembled and submitted.

By turning over your NDA creation and management to our Pharmaceutical Services practice, TBS’s subject matter experts can collect the necessary data from clinical trials, then create, manage, and deliver your NDA content to FDA regulators. TBS:

• Manages data collection and uploads it to a customized component content management system
• Summarizes data from charts and graphs, turning it into succinct discussions of safety and efficacy
• Adds citations from third-party medical and pharmaceutical journals via linking

All with an impressively low error rate.

Pharmaceutical marketing and labeling

The marketing and labeling of pharmaceutical products is highly regulated as well. Copy for product information and marketing sheets and websites must be straightforward, precise, unambiguous, and error free. All content must go through a stringent legal and regulatory review. Even the design parameters are proscribed.

This can make crafting documents, microsites, and social media campaigns slow and cumbersome.

TBS’s solutions include single-source, multiplatform content storage, as well as compliant document design, production, and delivery. And our “lights-out” publishing technology automates the review and approval process.